Primary outcomeLeast squares mean· Week 0, week 26
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)
| Group | Value (percentage of glycosylated haemoglobin) | Spread |
|---|---|---|
| IDeg | -0.99 | 0.08 |
| Placebo | -0.07 | 0.08 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataThe Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification
NCTNCT01664247 (opens ClinicalTrials.gov in a new tab)Other idNN1250-3944Other id2011-004665-32Other idU1111-1124-6612
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 346 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Double masking
- Countries
11 countries
United States, Canada, France, Germany, Israel, Italy, Serbia, South Africa, Ukraine, United Arab Emirates, United Kingdom
- Start
- 1 Oct 2012
- Primary completion
- 31 Dec 2013
- Completion
- 31 Dec 2013
- First posted
- 14 Aug 2012 (estimated)
- Last update posted
- 25 Sept 2017
- Conditions
- Diabetes · Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201220132014
- Ph 3
The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification
NCT016642471 Oct 2012 to 31 Dec 2013
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type 2 diabetes qualifying for treatment intensification.
Interventions
- insulin degludecDrug
- placeboDrug
- liraglutideDrug
Arms2
Experimental
IDeg + Lira
Experimental
Placebo + Lira
Primary outcomes1
Outcomes the sponsor listed as primary.
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)
Time frame · Week 0, week 26
Registry description
Change from baseline in HbA1c after 26 weeks of treatment
Secondary outcomes(8)
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame · Week 0, week 26
Registry description
Change from baseline in FPG after 26 weeks of treatment
Number of Responders for HbA1c (Below 7.0 %)
Time frame · After 26 weeks of randomised treatment.
Registry description
Number of responders for HbA1c below 7.0%, after 26 weeks of randomised treatment.
Change From Baseline in Mean Pre-breakfast Measurements Used for Titration
Time frame · Week 0, week 26
Registry description
Change from baseline after 26 weeks of treatment in the average of the pre-breakfast self measured plasma glucose (SMPG) measured on the day of the contact and the two days immediately prior to the contact. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.
Change From Baseline in 8-point Profile
Time frame · Week 0, week 26
Registry description
The change from baseline in the 8-point SMPG profile after 26 weeks of randomised treatment. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.
Change From Baseline in Mean of the 8-point Profile
Time frame · Week 0, week 26
Registry description
Change from baseline in mean of the 8-point profile after 26 weeks of randomised treatment.
Number of Hypoglycaemic Episodes
Time frame · Weeks 0 - 26
Registry description
Number of confirmed hypoglycaemic episodes from week 0 to 26 weeks of randomised treatment. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes.
Number of Adverse Events
Time frame · Weeks 0 - 26
Registry description
Number of treatment emergent AEs (TEAEs) from week 0 to week 26 of the randomised treatment. A TEAE was defined as an event that had 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.
Change From Baseline in Patient Reported Health-related Quality of Life Using the Short-Form 36 Health Survey Version 2 (SF-36®v2)
Time frame · Week 0, week 26
Registry description
Change in subject's quality of life was evaluated using the Short-Form 36 Health Survey version 2 (SF-36®v2). Evaluations were performed at baseline and at the last treatment visit (week 26). SF-36 was assessed on a scale range of 0.65 to 80.73 for physical health and -8.81 to 81.65 for mental health respectively, where higher scores indicated a better quality of life. 0-100 scores from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Week 0, week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
| Group | Value (mmol/L) | Spread |
|---|---|---|
| IDeg | -2.60 | 2.91 |
| Placebo | -0.28 | 2.44 |
Secondary outcomeNumber· After 26 weeks of randomised treatment.
Number of Responders for HbA1c (Below 7.0 %)
| Group | Value (percentage (%) of subjects) |
|---|---|
| IDeg | 77.6 |
| Placebo | 35.5 |
Secondary outcomeLeast squares mean· Week 0, week 26
Change From Baseline in Mean Pre-breakfast Measurements Used for Titration
| Group | Value (mmol/L) | Spread |
|---|---|---|
| IDeg | 5.88 | 0.14 |
| Placebo | 8.23 | 0.15 |
Secondary outcomeLeast squares mean· Week 0, week 26
Change From Baseline in 8-point Profile
| Group | Value (mmol/L) | Spread |
|---|---|---|
| IDeg | 5.85 | 0.15 |
| Placebo | 8.54 | 0.16 |
Secondary outcomeMean· Week 0, week 26
Change From Baseline in Mean of the 8-point Profile
| Group | Value (mmol/L) | Spread |
|---|---|---|
| IDeg | -2.3 | 1.8 |
| Placebo | -0.5 | 1.7 |
Secondary outcomeNumber· Weeks 0 - 26
Number of Hypoglycaemic Episodes
| Group | Value (events) |
|---|---|
| IDeg | 47 |
| Placebo | 9 |
Secondary outcomeNumber· Weeks 0 - 26
Number of Adverse Events
| Group | Value (events) |
|---|---|
| IDeg | 285 |
| Placebo | 252 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| IDegLiraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period. | – | 6 / 173 | 33 / 173 |
| PlaceboPlacebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject's choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period. | – | 9 / 170 | 32 / 170 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
More studies
1 study on this page
Indexing hint: Randomized controlled trial · 2016
Corrected
Effect of adding insulin degludec to treatment in patients with type 2 diabetes inadequately controlled with metformin and liraglutide: a double-blind randomized controlled trial (BEGIN: ADD TO GLP-1 Study).
Aroda et al. 2016Diabetes, obesity & metabolismcited by 27
PMID 26990378PMC5074260DOI 10.1111/dom.12661PUB-26990378
Free to read · publisher termsCC BY-NC-ND
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Type 2 diabetes
* Insulin naïve
* Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only twice daily (BID))
* Glycosylated haemoglobin (HbA1c) (by central laboratory analysis): a. 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy, b. 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or exenatide (only BID)
Exclusion Criteria:
* Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks
* Calcitonin equal to or above 50 pg/mL
* Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks
* Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)
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