Phase 3
Completed N=346
The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification
Source: ClinicalTrials.gov NCT01664247 ↗Enrolled (actual)
346
Serious AEs
4.4%
Results posted
Apr 2016
Primary outcomePrimary: Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) — -0.99; -0.07 percentage of glycosylated haemoglobin
◆ Published Evidence
Established
32citations · ~3 / year
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).
Summary
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.
Linked Publications
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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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) |
-0.99; -0.07 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
-2.60; -0.28 | — |
| SECONDARY Number of Responders for HbA1c (Below 7.0 %) |
77.6; 35.5 | — |
| SECONDARY Change From Baseline in Mean Pre-breakfast Measurements Used for Titration |
5.88; 8.23 | <.0001 sig |
| SECONDARY Change From Baseline in 8-point Profile |
5.85; 8.54; 7.65; 9.75; 6.33; 8.34 | <.0001 sig |
| SECONDARY Change From Baseline in Mean of the 8-point Profile |
-2.3; -0.5 | — |
| SECONDARY Number of Hypoglycaemic Episodes |
47; 9 | — |
| SECONDARY Number of Adverse Events |
285; 252 | — |
| SECONDARY Change From Baseline in Patient Reported Health-related Quality of Life Using the Short-Form 36 Health Survey Version 2 (SF-36®v2) |
0.5; 0.0; 0.6; -0.7 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01664247) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.