drugset / Trial / NCT01511172
Effect of Liraglutide as add-on to Metformin Compared to Either Liraglutide or Metformin Alone, or to a Combination of Metformin and a SU (Sulphonylurea) Agent in Subjects With Type 2 Diabetes
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic agents).
Timeline
- Start
- 2002-08
- Primary completion
- 2002-12
- Completion
- 2002-12
Outcome
Met primary endpoint
paper Liraglutide added to metformin monotherapy was associated with a significant reduction in fasting serum glucose (FSG) (-3.9 mM -4.9; -2.9) (primary objective) PMID 17039422 ↗
paper An improvement in FSG over that in control groups was seen for liraglutide as an add-on to metformin. PMID 17039422 ↗
Publications
- Results Nauck MA, Hompesch M, Filipczak R, Le TD, Zdravkovic M, Gumprecht J; NN2211-1499 Study Group. Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Sep;114(8):417-23. doi: 10.1055/s-2006-924230.
- Results Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glimepiride | Small molecule | — | Oral |
| Subject | Liraglutide | Peptide | 2 mg | Subcutaneous |
| Subject | Metformin | Small molecule | 1000 mg | Oral |