Clinical Trial Results:
A clinical trial comparing efficacy and safety of insulin degludec/liraglutide (IDegLira) in subjects with type 2 diabetes mellitus using two different titration algorithms (DUAL™ VI)
Summary
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EudraCT number |
2012-004625-25 |
Trial protocol |
HU BG AT SK CZ |
Global end of trial date |
23 Dec 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Jan 2017
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First version publication date |
07 Jan 2017
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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 |
NN9068-4056
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02298192 | ||
WHO universal trial number (UTN) |
U1111-1135-6634 | ||
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 |
Global Clinical Registry (GCR 1452), Novo Nordisk A/S, Clinicaltrials@novonordisk.com
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Scientific contact |
Global Clinical Registry (GCR 1452), Novo Nordisk A/S, clinicaltrials@novnordisk.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 |
15 Jun 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Dec 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Dec 2015
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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 |
To confirm the efficacy of insulin degludec/liraglutide (IDegLira), using a once weekly titration
algorithm, in controlling glycaemia in insulin-naïve subjects with type 2 diabetes (T2DM),
inadequately controlled on metformin alone or in combination with pioglitazone. This is done by
comparing the difference in change from baseline HbA1c (glycosylated haemoglobin) after 32
weeks of treatment to a non-inferiority limit of 0.30 % for once weekly titration vs. twice weekly
titration.
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Protection of trial subjects |
The trial was conducted in accordance with the Declaration of Helsinki (64th WMA Assembly, October 2013) and ICH Good Clinical Practice (May 1996) and 21 CFR 312.120.
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Background therapy |
- | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
21 Nov 2014
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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 |
Austria: 30
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Country: Number of subjects enrolled |
Bulgaria: 40
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Country: Number of subjects enrolled |
Canada: 30
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Country: Number of subjects enrolled |
Czech Republic: 35
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Country: Number of subjects enrolled |
Hungary: 42
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Country: Number of subjects enrolled |
Serbia: 39
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Country: Number of subjects enrolled |
Russian Federation: 35
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Country: Number of subjects enrolled |
Slovakia: 60
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Country: Number of subjects enrolled |
United States: 109
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Worldwide total number of subjects |
420
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EEA total number of subjects |
207
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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) |
328
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From 65 to 84 years |
92
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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 80 sites in 9 countries as follows: Austria: 6 sites; Bulgaria: 5 sites; Canada: 7 sites, Czech Republic: 5 sites; Hungary: 4 sites, Russian Federation: 6 sites; Serbia: 4 sites, Slovakia: 7 sites; United States: 36 sites. | |||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Stable daily treatment with metformin (≥1500 mg or max tolerated dose) ± pioglitazone (≥30 mg) for at least 90 days prior to screening. | |||||||||||||||||||||||||||
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 |
Not blinded | |||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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IDegLira 1WT | |||||||||||||||||||||||||||
Arm description |
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50 units/1.8mg liraglutide). The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured prebreakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day. | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
Liraglutide
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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 |
IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed insulin degludec/liraglutide ratio of 100 units/3.6 mg per mL solution subcutaneously in the thigh, upper arm(deltoid) or abdomen approximately at the same time everyday.
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Investigational medicinal product name |
Insulin Degludec
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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 |
IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed insulin degludec/liraglutide ratio of 100 units/3.6 mg per mL solution subcutaneously in the thigh, upper arm(deltoid) or abdomen approximately at the same time everyday.
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Arm title
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IDegLira | |||||||||||||||||||||||||||
Arm description |
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group, the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured prebreakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day. | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
Liraglutide
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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 |
IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed insulin degludec/liraglutide ratio of 100 units/3.6 mg per mL solution subcutaneously in the thigh, upper arm(deltoid) or abdomen approximately at the same time everyday.
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Investigational medicinal product name |
Insulin Degludec
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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 |
IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed insulin degludec/liraglutide ratio of 100 units/3.6 mg per mL solution subcutaneously in the thigh, upper arm(deltoid) or abdomen approximately at the same time everyday.
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Baseline characteristics reporting groups
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Reporting group title |
IDegLira 1WT
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Reporting group description |
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50 units/1.8mg liraglutide). The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured prebreakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
IDegLira
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Reporting group description |
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group, the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured prebreakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
IDegLira 1WT
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Reporting group description |
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50 units/1.8mg liraglutide). The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured prebreakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day. | ||
Reporting group title |
IDegLira
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Reporting group description |
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group, the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured prebreakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day. |
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End point title |
Change from baseline in HbA1c | ||||||||||||
End point description |
Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment. Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.
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End point type |
Primary
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End point timeframe |
Week 0, week 32
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Statistical analysis title |
Statistical analysis | ||||||||||||
Statistical analysis description |
A standard MMRM model was applied for primary endpoint. The model included treatment, visit, region and previous OAD treatment as fixed factors and the corresponding baseline value as a covariate with an unstructured covariance structure. Interactions between visit and all factors and covariates were also included in the model. In the following, this model will be referred to as the standard MMRM model.
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Comparison groups |
IDegLira v IDegLira 1WT
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Number of subjects included in analysis |
389
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.012 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Treatment-Contrast | ||||||||||||
Point estimate |
0.12
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.04 | ||||||||||||
upper limit |
0.28 |
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End point title |
HbA1c below 7.0% | ||||||||||||||||||
End point description |
Responders to HbA1c below 7% after 32 weeks of treatment. Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.
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End point type |
Secondary
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End point timeframe |
Week 0, week 32
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No statistical analyses for this end point |
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End point title |
HbA1c below or equal to 6.5% | ||||||||||||||||||
End point description |
Responders to HbA1c below or equal to 6.5% after 32 weeks of treatment. Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.
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End point type |
Secondary
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End point timeframe |
Week 0, week 32
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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 |
Defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. (Visit 1- Visit 36)
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Adverse event reporting additional description |
Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation “as treated”.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
IDegLira
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Reporting group description |
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group, the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured prebreakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
IDegLira (1WT)
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Reporting group description |
Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50 units/1.8mg liraglutide). The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured prebreakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |