Clinical Trial Results:
A trial comparing the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart in subjects with type 2 diabetes mellitus previously treated with insulin glargine
Summary
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EudraCT number |
2012-000373-23 |
Trial protocol |
DE |
Global end of trial date |
22 Aug 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Mar 2016
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First version publication date |
28 Jul 2015
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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 |
NN5401-3941
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01680341 | ||
WHO universal trial number (UTN) |
U1111-1127-4114 | ||
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@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 |
26 Jan 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
22 Aug 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Aug 2013
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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 the insulin degludec/insulin aspart (IDegAsp) twice daily (BID) simple titration algorithm in controlling glycaemia with respect to change from baseline in glycosylated haemoglobin (HbA1c) after 26 weeks of treatment.
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Protection of trial subjects |
The trial was conducted in accordance with the Declaration of Helsinki and ICH Good Clinical Practice and EN ISO 14155 Part 1 and 2.
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Background therapy |
While entering the treatment period the subjects discontinued IGlar and sulfonylurea (SU)/glinides (if administered) but continued treatment with other OADs as prescribed. i.e. metformin, DPP-4 inhibitor or alpha-glucosidase inhibitor. | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
31 Aug 2012
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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 |
Germany: 39
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Country: Number of subjects enrolled |
Algeria: 35
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Country: Number of subjects enrolled |
Malaysia: 33
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Country: Number of subjects enrolled |
Turkey: 10
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Country: Number of subjects enrolled |
United States: 155
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Worldwide total number of subjects |
272
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EEA total number of subjects |
39
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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) |
202
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From 65 to 84 years |
70
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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 43 sites in 5 countries as follows: 3 sites in Algeria, 5 sites in Germany, 3 sites in Malaysia, 3 sites in Turkey, 29 sites in United States. | |||||||||||||||||||||
Pre-assignment
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Screening details |
At screening, subjects were on IGlar and up to 3 OADs (metformin, DPP-4 inhibitor, SU/glinides or alpha-glucosidase inhibitor) therapy. These pre-trial assignments were ongoing from ≥12 weeks prior to randomisation and doses were stabilised in this period of time. | |||||||||||||||||||||
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 | |||||||||||||||||||||
Blinding implementation details |
This was an open-label trial. There was no blinding of investigators or subjects. An open label trial design was chosen since all subjects in both treatment arms were to receive insulin treatment with IDegAsp BID and since blinding of the different titration algorithms would not have been possible.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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IDegAsp Simple | |||||||||||||||||||||
Arm description |
Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the simple titration algorithm. IDegAsp doses were self-titrated, twice weekly (at intervals of 3-4 days) based upon a single pre-breakfast and single pre-dinner self-measured plasma glucose (SMPG) values. The titration of the morning dose was to be based on the previous evening's pre-dinner SMPG measurement and the titration of the dinner dose was to be based on the pre-breakfast SMPG measurement taken on the day of titration. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
IDegAsp
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Investigational medicinal product code |
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Other name |
Insulin degludec and Insulin aspart
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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 |
Twice weekly self-titration at intervals of 3-4 days, based upon a single pre-breakfast and pre-dinner SMPG (self-measured plasma glucose) value, with subcutaneous (s.c., under the skin) administration.
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Arm title
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IDegAsp Stepwise | |||||||||||||||||||||
Arm description |
Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the step-wise titration algorithm. IDegAsp doses were self-titrated, once weekly, based on lowest of 3 pre-breakfast and 3 pre-dinner self-measured plasma glucose (SMPG) values, (measurements on 3 consecutive days prior to titration). The titration of the morning dose was to be based on the pre-dinner SMPG measurements and the titration of the dinner dose was to be based on the pre-breakfast SMPG measurements. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
IDegAsp
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Investigational medicinal product code |
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Other name |
Insulin degludec and Insulin aspart
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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 |
Once weekly self-titration based upon the lowest of 3 pre-breakfast and 3 pre-dinner SMPG (self-measured plasma glucose) values, with subcutaneous (s.c., under the skin) administration.
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Baseline characteristics reporting groups
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Reporting group title |
IDegAsp Simple
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Reporting group description |
Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the simple titration algorithm. IDegAsp doses were self-titrated, twice weekly (at intervals of 3-4 days) based upon a single pre-breakfast and single pre-dinner self-measured plasma glucose (SMPG) values. The titration of the morning dose was to be based on the previous evening's pre-dinner SMPG measurement and the titration of the dinner dose was to be based on the pre-breakfast SMPG measurement taken on the day of titration. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
IDegAsp Stepwise
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Reporting group description |
Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the step-wise titration algorithm. IDegAsp doses were self-titrated, once weekly, based on lowest of 3 pre-breakfast and 3 pre-dinner self-measured plasma glucose (SMPG) values, (measurements on 3 consecutive days prior to titration). The titration of the morning dose was to be based on the pre-dinner SMPG measurements and the titration of the dinner dose was to be based on the pre-breakfast SMPG measurements. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
IDegAsp Simple
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Reporting group description |
Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the simple titration algorithm. IDegAsp doses were self-titrated, twice weekly (at intervals of 3-4 days) based upon a single pre-breakfast and single pre-dinner self-measured plasma glucose (SMPG) values. The titration of the morning dose was to be based on the previous evening's pre-dinner SMPG measurement and the titration of the dinner dose was to be based on the pre-breakfast SMPG measurement taken on the day of titration. | ||
Reporting group title |
IDegAsp Stepwise
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Reporting group description |
Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the step-wise titration algorithm. IDegAsp doses were self-titrated, once weekly, based on lowest of 3 pre-breakfast and 3 pre-dinner self-measured plasma glucose (SMPG) values, (measurements on 3 consecutive days prior to titration). The titration of the morning dose was to be based on the pre-dinner SMPG measurements and the titration of the dinner dose was to be based on the pre-breakfast SMPG measurements. |
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End point title |
Change from baseline in HbA1c (%) | ||||||||||||
End point description |
Change from baseline in HbA1c (%) after 26 weeks of treatment.
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End point type |
Primary
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End point timeframe |
At end of 26 weeks of treatment
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Statistical analysis title |
Change from baseline in HbA1c (%). | ||||||||||||
Statistical analysis description |
Change from baseline in HbA1c after 26 weeks of treatments is analysed using an ANOVA method with treatment, sex and region as fixed effects, and age and baseline HbA1c as covariates.
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Comparison groups |
IDegAsp Simple v IDegAsp Stepwise
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Number of subjects included in analysis |
272
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
ANOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.11
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Confidence interval |
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level |
95% | ||||||||||||
sides |
1-sided
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lower limit |
- | ||||||||||||
upper limit |
0.11 | ||||||||||||
Variability estimate |
Standard error of the mean
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End point title |
Change from baseline in fasting plasma glucose (FPG) | ||||||||||||
End point description |
Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment.
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End point type |
Secondary
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End point timeframe |
At end of 26 weeks of treatment
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No statistical analyses for this end point |
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End point title |
Proportion of subjects achieving HbA1c< 7.0% | |||||||||
End point description |
Proportion of subjects achieving HbA1c< 7.0% at end of 26 weeks of treatment.
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End point type |
Secondary
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End point timeframe |
At end of 26 weeks of treatment
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No statistical analyses for this end point |
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End point title |
Proportion of subjects with HbA1c< 7.0% without confirmed hypoglycaemic episodes | |||||||||
End point description |
Proportion of subjects with HbA1c< 7.0% without confirmed hypoglycaemic episodes during the last 12 weeks of treatment or within 7 days from last randomised treatment including only subjects exposed for at least 12 weeks.
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End point type |
Secondary
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End point timeframe |
At end of 26 weeks of treatment.
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No statistical analyses for this end point |
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End point title |
Self-measured plasma glucose measurements (SMPGs) of the 8-point profiles | ||||||||||||||||||||||||||||||||||||
End point description |
Self-measured plasma glucose measurements (SMPGs) of the 8-point profiles at the end of 26 weeks of treatment.
(N: Number of subjects)
1. Before breakfast: N in IDegAsp Simple = 134, IDegAsp Step wise = 131
2. 90 minutes after start of breakfast : N in IDegAsp Simple = 129, IDegAsp Step wise = 126
3. Before lunch: N in IDegAsp Simple = 131, IDegAsp Step wise = 126
4. 90 minutes after start of lunch: N in IDegAsp Simple = 128, IDegAsp Step wise = 127
5. Before main evening meal: N in IDegAsp Simple = 133, IDegAsp Step wise = 128
6. 90 minutes after main evening meal: N in IDegAsp Simple = 127, IDegAsp Step wise = 128
7. Before bedtime: N in IDegAsp Simple = 121, IDegAsp Step wise = 116
8. Before breakfast the following day: N in IDegAsp Simple = 135, IDegAsp Step wise = 131
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End point type |
Secondary
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End point timeframe |
At the end of 26 weeks of treatment
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No statistical analyses for this end point |
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End point title |
Self-measured plasma glucose measurements (SMPGs) of the Mean of the 8-point profile | ||||||||||||
End point description |
Self-measured plasma glucose measurements (SMPGs) of the mean of the 8-point profile at end of 26 weeks of treatment.
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End point type |
Secondary
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End point timeframe |
At end of 26 weeks of treatment.
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No statistical analyses for this end point |
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End point title |
Self-measured Prandial plasma glucose (SMPGs) increment from 8-point profile | ||||||||||||||||||||||||
End point description |
Self-measured Prandial plasma glucose (SMPGs) increment from 8-point profile at end of 26 weeks of treatment.
(N: Number of subjects)
1. Mean of SMPG increment-All Meal: N in IDegAsp Simple = 130, N in IDegAsp Step wise = 129
2. SMPG increment-Breakfast: N in IDegAsp Simple = 131, N in IDegAsp Step wise = 129
3. SMPG increment-Lunch: N in IDegAsp Simple = 132, N in IDegAsp Step wise = 129
4. SMPG increment-Evening Meal: N in IDegAsp Simple = 130, N in IDegAsp Step wise = 127
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End point type |
Secondary
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End point timeframe |
At end of 26 weeks of treatment
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No statistical analyses for this end point |
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End point title |
Incidence of treatment emergent adverse events (TEAEs) | |||||||||
End point description |
A treatment emergent adverse event (TEAE) was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
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End point type |
Secondary
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End point timeframe |
During 28 weeks of trial
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Notes [1] - 242 adverse events were reported in 87 subjects. [2] - 286 adverse events were reported in 89 subjects. |
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No statistical analyses for this end point |
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End point title |
Number of treatment emergent confirmed hypoglycaemic episodes according to the Novo Nordisk definition for confirmed hypoglycaemic episodes | |||||||||
End point description |
Number of treatment emergent confirmed hypoglycaemic episodes according to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured PG < 3.1 mmol/L (< 56 mg/dL) during 28 weeks of trial.
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End point type |
Secondary
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End point timeframe |
During 28 weeks of trial
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Notes [3] - 552 confirmed hypoglycaemic episodes were reported by 93 subjects. [4] - 323 confirmed hypoglycaemic episodes were reported by 78 subjects. |
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No statistical analyses for this end point |
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End point title |
Number of treatment emergent hypoglycaemic episodes according to the American Diabetes Association (ADA) definition ≤ 3.9 mmol/L (≤ 70 mg/dL) | |||||||||
End point description |
Number of treatment emergent hypoglycaemic episodes according to the American Diabetes Association (ADA) definition ≤ 3.9 mmol/L (≤ 70 mg/dL).
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End point type |
Secondary
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End point timeframe |
During 28 weeks of trial
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Notes [5] - 2226 hypoglycaemic episodes were reported by 122 subjects. [6] - 1270 hypoglycaemic episodes were reported by 113 subjects. |
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No statistical analyses for this end point |
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End point title |
Number of treatment emergent confirmed hypoglycaemic episodes in the maintenance period | ||||||||||||||||||
End point description |
Number of treatment emergent confirmed hypoglycaemic episodes in the maintenance period (from week 16 to end of trial including follow-up).
N = Number of subjects
1. Confirmed episodes: N in IDegAsp Simple = 64, N in IDegAsp Step wise = 50
2. ADA classified episodes: N in IDegAsp Simple = 109, N in IDegAsp Step wise = 94
3. ADA unclassifiable episodes: N in IDegAsp Simple = 3, N in IDegAsp Step wise = 4
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End point type |
Secondary
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End point timeframe |
From week 16 to end of trial including follow-up
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No statistical analyses for this end point |
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End point title |
Number of treatment emergent nocturnal (00:01-05:59) confirmed hypoglycaemic episodes | ||||||||||||||||||
End point description |
Number of treatment emergent nocturnal (00:01-05:59) confirmed hypoglycaemic episodes during 28 weeks of trial. (N: Number of subjects)
1. Confirmed episodes: N in IDegAsp Simple = 37, N in IDegAsp Step wise = 24
2. ADA classifiable episodes: N in IDegAsp Simple = 71, N in IDegAsp Step wise = 46
3. ADA Unclassifiable episodes: N in IDegAsp Simple = 0, N in IDegAsp Step wise = 0
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End point type |
Secondary
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End point timeframe |
During 28 weeks of trial
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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 the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period.
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Adverse event reporting additional description |
An adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16
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Reporting groups
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Reporting group title |
IDegAsp Simple
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Reporting group description |
Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the simple titration algorithm. IDegAsp doses were self-titrated, twice weekly (at intervals of 3-4 days) based on single pre-breakfast and single pre-dinner self-measured plasma glucose (SMPG) levels, with subcutaneous (s.c., under the skin) administration. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
IDegAsp Stepwise
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Reporting group description |
Subjects received insulin treatment with IDegAsp (co-formulated basal-bolus injection), for a treatment period of 26 weeks, using the step-wise titration algorithm. IDegAsp doses were self-titrated, once weekly, based on lowest of 3 pre-breakfast and 3 pre-dinner self-measured plasma glucose (SMPG) levels, with subcutaneous (s.c., under the skin) administration. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/23710902 |