Study S000398

The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes. A 26 Week, Randomised, Open-label, Parallel-group, Multicentre, Multinational Trial With a 26 Week Extension

ClinicalTrials.gov record

Registration

Registration: NCT00856986
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 987
Start: 2009-03
Primary completion: 2010-04
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:liraglutide; DRUG:insulin detemir; DRUG:metformin
Results posted: TRUE
Secondary identifiers: EUDRACT_NUMBER:2007-005317-19

Registered primary outcomes

Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26. [Week 0 (Randomisation), week 26]

Linked records (3)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0023483	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. Jensen TM, Diabetes care	2015	Systematic review	PMID 25504028 DOI	registry reference RESULT:25504028
R0027281	One-year sustained glycemic control and weight reduction in type 2 diabetes after addition of liraglutide to metformin followed by insulin detemir according to HbA1c target. Rosenstock J, Journal of diabetes and its complications	2013	Randomized trial	PMID 23746555 DOI	registry reference RESULT:23746555
R0027284	Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets. DeVries JH, Diabetes care	2012	Randomized trial	PMID 22584132 DOI	cites ClinicalTrials.gov:NCT00856986; registry reference RESULT:22584132