Clinical Trial Results:
A 26-week double blinded, multiregional trial comparing the effect and safety of once weekly insulin icodec and once daily insulin degludec 100 units/mL, both in combination with non-insulin anti-diabetic drugs, in insulin naive subjects with type 2 diabetes
Summary
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EudraCT number |
2020-000472-37 |
Trial protocol |
CZ AT DK FR |
Global end of trial date |
23 Jun 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Jul 2023
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First version publication date |
14 Jul 2023
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
NN1436-4479
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04795531 | ||
WHO universal trial number (UTN) |
U1111-1247-5218 | ||
Sponsors
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Sponsor organisation name |
Novo Nordisk A/S
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Sponsor organisation address |
Novo Allé, Bagsvaerd, Denmark, 2880
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Public contact |
Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com
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Scientific contact |
Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
25 Aug 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Jun 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of the trial was to demonstrate the effect on glycaemic control of once weekly insulin icodec, in combination with non-insulin anti-diabetic drugs, in insulin naïve subjects withtype 2 diabtetes mellitus (T2D).
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Protection of trial subjects |
The trial was conducted in accordance with the Declaration of Helsinki (64th World Medical Association (WMA) general Assembly; Oct 2013) and International Council for Harmonisation (ICH) Good Clinical Practice, including archiving of essential documents, (Current Step 4 version, Nov 2016) and 21 Code of Federal Regulations (CFR) 312.120.
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Background therapy |
After randomisation subjects continued their pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which had to be reduced at randomisation by approximately 50% at the discretion of the investigator. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 Mar 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Argentina: 55
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Country: Number of subjects enrolled |
Austria: 28
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Country: Number of subjects enrolled |
Brazil: 51
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Country: Number of subjects enrolled |
Canada: 54
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Country: Number of subjects enrolled |
China: 100
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Country: Number of subjects enrolled |
Czechia: 51
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Country: Number of subjects enrolled |
Denmark: 32
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Country: Number of subjects enrolled |
France: 31
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Country: Number of subjects enrolled |
Mexico: 46
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Country: Number of subjects enrolled |
Taiwan: 45
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Country: Number of subjects enrolled |
United States: 95
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Worldwide total number of subjects |
588
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EEA total number of subjects |
142
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
411
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From 65 to 84 years |
177
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85 years and over |
0
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Recruitment
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Recruitment details |
The trial was conducted at 89 sites in 11 countries as follows (number of sites that screened participants/ number of sites that randomised participants): Argentina (4/4), Austria (3/3), Brazil (4/4), Canada (14/13), China mainland (13/13), Czech Republic (6/6), Denmark (4/4), France (9/8), Mexico (2/2), Taiwan (5/5), United States (28/27). | ||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
After randomisation subjects continued their pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which had to be reduced at randomisation by approximately 50% at the discretion of the investigator. | ||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||
Roles blinded |
Investigator, Subject | ||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Insulin icodec | ||||||||||||||||||||||||||||||
Arm description |
Subjects were to receive once weekly subcutaneous (s.c.) injection of insulin icodec using PDS290 prefilled pen-injector at a starting dose of 70 units (U) and once weekly placebo for 26 weeks. The dose was then adjusted once weekly to reach the glycaemic target of 4.4-7.2 millimoles per liter (mmol/L) based on 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; If the mean was: 4.4-7.2 mmol/L- no adjustment; > 7.2 mmol/L- dose increased by 20 U. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Insulin icodec 700 U/mL
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects received once weekly placebo matched to insulin icodec subcutaneously at an initial dose of 70 U using 3 mL PDS290 pre-filled pen-injector for 26 weeks.
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Investigational medicinal product name |
Insulin icodec 700 U/mL PDS290
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects were to receive once weekly subcutaneous (s.c.) injection of insulin icodec using PDS290 prefilled pen-injector at a starting dose of 70 units (U) and once weekly placebo for 26 weeks. The dose was then adjusted once weekly to reach the glycaemic target of 4.4-7.2 millimoles per liter (mmol/L) based on 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; If the mean was: 4.4-7.2 mmol/L- no adjustment; > 7.2 mmol/L- dose increased by 20 U.
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Arm title
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Insulin degludec | ||||||||||||||||||||||||||||||
Arm description |
Subjects were to receive once daily s.c. injection of insulin degludec using PDS290 prefilled pen-injector at a starting dose of 10 U and once daily placebo for 26 weeks. The dose was then adjusted once weekly to reach the glycaemic target of 4.4-7.2 millimoles per liter mmol/L based on 3 pre-breakfast values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 3 U; If the mean was: 4.4-7.2 mmol/L- no adjustment; > 7.2 mmol/L- dose increased by 3 U. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Tresiba 100 units/mL
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects received once daily placebo matched to insulin degludec subcutaneously at an initial dose of 10 U using 3 mL PDS290 pre-filled pen-injector for 26 weeks.
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Investigational medicinal product name |
Tresiba 100 units/mL
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects were to receive once daily s.c. injection of insulin degludec using PDS290 prefilled pen-injector at a starting dose of 10 U and once daily placebo for 26 weeks. The dose was then adjusted once weekly to reach the glycaemic target of 4.4-7.2 millimoles per liter mmol/L based on 3 pre-breakfast values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 3 U; If the mean was: 4.4-7.2 mmol/L- no adjustment; > 7.2 mmol/L- dose increased by 3 U.
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Baseline characteristics reporting groups
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Reporting group title |
Insulin icodec
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Reporting group description |
Subjects were to receive once weekly subcutaneous (s.c.) injection of insulin icodec using PDS290 prefilled pen-injector at a starting dose of 70 units (U) and once weekly placebo for 26 weeks. The dose was then adjusted once weekly to reach the glycaemic target of 4.4-7.2 millimoles per liter (mmol/L) based on 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; If the mean was: 4.4-7.2 mmol/L- no adjustment; > 7.2 mmol/L- dose increased by 20 U. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Insulin degludec
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Reporting group description |
Subjects were to receive once daily s.c. injection of insulin degludec using PDS290 prefilled pen-injector at a starting dose of 10 U and once daily placebo for 26 weeks. The dose was then adjusted once weekly to reach the glycaemic target of 4.4-7.2 millimoles per liter mmol/L based on 3 pre-breakfast values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 3 U; If the mean was: 4.4-7.2 mmol/L- no adjustment; > 7.2 mmol/L- dose increased by 3 U. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Insulin icodec
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Reporting group description |
Subjects were to receive once weekly subcutaneous (s.c.) injection of insulin icodec using PDS290 prefilled pen-injector at a starting dose of 70 units (U) and once weekly placebo for 26 weeks. The dose was then adjusted once weekly to reach the glycaemic target of 4.4-7.2 millimoles per liter (mmol/L) based on 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; If the mean was: 4.4-7.2 mmol/L- no adjustment; > 7.2 mmol/L- dose increased by 20 U. | ||
Reporting group title |
Insulin degludec
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Reporting group description |
Subjects were to receive once daily s.c. injection of insulin degludec using PDS290 prefilled pen-injector at a starting dose of 10 U and once daily placebo for 26 weeks. The dose was then adjusted once weekly to reach the glycaemic target of 4.4-7.2 millimoles per liter mmol/L based on 3 pre-breakfast values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 3 U; If the mean was: 4.4-7.2 mmol/L- no adjustment; > 7.2 mmol/L- dose increased by 3 U. |
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End point title |
Change in glycated haemoglobin (HbA1c) | ||||||||||||
End point description |
Change in HbA1c from baseline week 0 (V2) to week 26 (V28) is presented. The endpoint data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct subject-site contact, withdrawal for subjects who withdrew their informed consent, the last subject-investigator contact as defined by the investigator for subjects who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for subjects who died before any of the above. Full analysis set (FAS) included all randomised subjects.
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End point type |
Primary
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End point timeframe |
From baseline week 0 (V2) to week 26 (V28)
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Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment, region and SU/glinides use as fixed factors, and baseline response as covariate.
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Comparison groups |
Insulin icodec v Insulin degludec
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Number of subjects included in analysis |
588
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | ||||||||||||
P-value |
< 0.0001 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Treatment difference | ||||||||||||
Point estimate |
-0.21
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.34 | ||||||||||||
upper limit |
-0.08 | ||||||||||||
Notes [1] - Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin degludec) was strictly below 0.3%. |
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End point title |
Change in fasting plasma glucose (FPG) | ||||||||||||
End point description |
Change in FPG from baseline week 0 (V2) to week 26 (V28) is presented. The endpoint data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct subject-site contact, withdrawal for subjects who withdrew their informed consent, the last subject-investigator contact as defined by the investigator for subjects who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for subjects who died before any of the above. FAS included all randomised subjects. Number of subjects analyzed=subjects with available data for this endpoint.
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End point type |
Secondary
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End point timeframe |
From baseline week 0 (V2) to week 26 (V28)
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No statistical analyses for this end point |
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End point title |
Number of severe hypoglycaemic episodes (level 3) | ||||||||||||
End point description |
Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The endpoint data was evaluated based on the on-treatment observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a subject was considered exposed to trial product. Safety analysis set included all subjects who were randomly assigned to trial treatment and who took at least 1 dose of trial product.
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End point type |
Secondary
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End point timeframe |
From baseline week 0 (V2) to week 31 (V30)
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No statistical analyses for this end point |
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End point title |
Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 mmol/L (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose [BG] meter) | ||||||||||||
End point description |
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 millimoles per liter [mmol/L] (54 mg/dL), confirmed by BG meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The endpoint data was evaluated based on on-treatment observation period. On-treatment period started at the date of first dose of trial product and ended at the first date of any of the following: End of trial visit (V30), Last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of dosing interval for both treatment arms) and the end-date for in-trial observation period. The on-treatment period represented the time period in which a subject was considered exposed to trial product. Safety analysis set included all subjects who were randomly assigned to trial treatment and who took at least 1 dose of trial product.
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End point type |
Secondary
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End point timeframe |
From baseline week 0 (V2) to week 31 (V30)
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No statistical analyses for this end point |
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End point title |
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) | ||||||||||||
End point description |
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The endpoint data was evaluated based on on-treatment observation period. On-treatment period started at the date of first dose of trial product and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin and the end-date for in-trial observation period. Safety analysis set included all subjects who were randomly assigned to trial treatment and who took at least 1 dose of trial product.
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End point type |
Secondary
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End point timeframe |
From baseline week 0 (V2) to week 31 (V30)
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No statistical analyses for this end point |
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End point title |
Number of severe hypoglycaemic episodes (level 3) from baseline week 0 (V2) to week 26 (V28) | ||||||||||||
End point description |
Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Safety analysis set included all subjects who were randomly assigned to trial treatment and who took at least 1 dose of trial product.
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End point type |
Secondary
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End point timeframe |
From baseline week 0 (V2) to week 26 (V28)
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No statistical analyses for this end point |
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End point title |
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) from baseline week 0 (V2) to week 26 (V28) | ||||||||||||
End point description |
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The endpoint data was evaluated based on on-treatment observation period. On-treatment period started at the date of first dose of trial product and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin and the end-date for in-trial observation period. Safety analysis set included all subjects who were randomly assigned to trial treatment and who took at least 1 dose of trial product.
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End point type |
Secondary
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End point timeframe |
From baseline week 0 (V2) to week 26 (V28)
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No statistical analyses for this end point |
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End point title |
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) from baseline week 0 (V2) to week 26 (V28) | ||||||||||||
End point description |
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The endpoint data was evaluated based on on-treatment observation period. On-treatment period started at the date of first dose of trial product and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin and the end-date for in-trial observation period. Safety analysis set included all subjects who were randomly assigned to trial treatment and who took at least 1 dose of trial product.
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End point type |
Secondary
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End point timeframe |
From baseline week 0 (V2) to week 26 (V28)
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No statistical analyses for this end point |
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End point title |
Change in body weight | ||||||||||||
End point description |
Change in body weight from baseline week 0 (V2) to week 26 (V28) is presented. The endpoint data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct subject-site contact, withdrawal for subjects who withdrew their informed consent, the last subject-investigator contact as defined by the investigator for subjects who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for subjects who died before any of the above. Full analysis set included all randomised subjects.
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End point type |
Secondary
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End point timeframe |
From baseline week 0 (V2) to week 26 (V28)
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No statistical analyses for this end point |
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End point title |
Mean weekly insulin dose | ||||||||||||
End point description |
Estimated mean weekly insulin dose during the last 2 weeks of treatment (from week 24 to week 26) is presented. The endpoint data was evaluated based on the on-treatment observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a subject was considered exposed to trial product. FAS included all randomised subjects.
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End point type |
Secondary
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End point timeframe |
From week 24 (P26) to week 26 (V28)
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From week 0 to week 31
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Adverse event reporting additional description |
All presented AEs are treatment-emergent adverse events (TEAEs). Adverse events were defined as treatment-emergent if the onset of event occurs in the on-treatment period (from week 0 to week 26). Results are based on safety analysis set which included all subjects randomly assigned to trial treatment and who took at least 1 dose of trial product.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24
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Reporting groups
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Reporting group title |
Insulin degludec
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Reporting group description |
Subjects were to receive once daily s.c. injection of insulin degludec using PDS290 prefilled pen-injector at a starting dose of 10 U and once daily placebo for 26 weeks. The dose was then adjusted once weekly to reach the glycaemic target of 4.4-7.2 millimoles per liter mmol/L based on 3 pre-breakfast values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 3 U; If the mean was: 4.4-7.2 mmol/L- no adjustment; > 7.2 mmol/L- dose increased by 3 U. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Insulin Icodec
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Reporting group description |
Subjects were to receive once weekly subcutaneous (s.c.) injection of insulin icodec using PDS290 prefilled pen-injector at a starting dose of 70 units (U) and once weekly placebo for 26 weeks. The dose was then adjusted once weekly to reach the glycaemic target of 4.4-7.2 millimoles per liter (mmol/L) based on 3 pre-breakfast self-measured plasma glucose (SMPG) values measured on 2 previous days and on the day of the titration. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; If the mean was: 4.4-7.2 mmol/L- no adjustment; > 7.2 mmol/L- dose increased by 20 U. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |