Study S002312

A Phase IV, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Effect of 12-week Treatment With the Glucagon-like Peptide-1 Receptor Agonist (GLP-1RA) Liraglutide or Dipeptidyl Peptidase-4 Inhibitor (DPP-4i) Sitagliptin on the Cardiovascular, Renal and Gastrointestinal System in Insulin-naïve Patients With Type 2 Diabetes (T2DM).

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT01744236
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: DOUBLE
Status: COMPLETED
Enrollment: 70
Start: 2013-04
Primary completion: 2015-08
Lead sponsor: Amsterdam UMC, location VUmc
Conditions: Type 2 Diabetes
Interventions: DRUG:Liraglutide; DRUG:Sitagliptin; DRUG:Exenatide; DRUG:Liraglutide placebo; DRUG:Sitagliptin placebo; DRUG:Exenatide placebo; DRUG:L-NMMA
Results posted: FALSE
Secondary identifiers: OTHER:U1111-1130-8248; EUDRACT_NUMBER:2012-003256-36

Registered primary outcomes

Changes from baseline following infusion of GLP-1RA (acute effects) and the changes from baseline following 12-week treatment with GLP-1RA or DPP-4i (long-term effects) on resting heart rate variability, as derived from electrocardiographic measurements. [12 weeks]
Changes from baseline following infusion of GLP-1RA (acute effects) and the changes from baseline following 12-week treatment with GLP-1RA or DPP-4i (long-term effects) on Glomerular Filtration Rate, measured by the inulin-clearance technique. [12 weeks]
Changes from baseline following 12-week treatment with GLP-1RA or DPP-4i (long-term effects) on pancreatic exocrine function, measured as fecal Elastase-1. [12 weeks]

Linked records (6)

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
R0016542	Liraglutide and sitagliptin have no effect on intestinal microbiota composition: A 12-week randomized placebo-controlled trial in adults with type 2 diabetes. Smits MM, Diabetes & metabolism	2021	Randomized trial	PMID 33429063 DOI	cites ClinicalTrials.gov:NCT01744236; registry reference DERIVED:33429063
R0013843	Acute renal effects of the GLP-1 receptor agonist exenatide in overweight type 2 diabetes patients: a randomised, double-blind, placebo-controlled trial. Tonneijck L, Diabetologia	2016	Randomized trial	PMID 27038451 DOI	cites ClinicalTrials.gov:NCT01744236; registry reference DERIVED:27038451
R0020426	Biliary effects of liraglutide and sitagliptin, a 12-week randomized placebo-controlled trial in type 2 diabetes patients. Smits MM, Diabetes, obesity & metabolism	2016	Randomized trial	PMID 27451030 DOI	cites ClinicalTrials.gov:NCT01744236; registry reference DERIVED:27451030
R0022406	Renal Effects of DPP-4 Inhibitor Sitagliptin or GLP-1 Receptor Agonist Liraglutide in Overweight Patients With Type 2 Diabetes: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial. Tonneijck L, Diabetes care	2016	Randomized trial	PMID 27585605 DOI	cites ClinicalTrials.gov:NCT01744236; registry reference DERIVED:27585605
R0023036	Twelve week liraglutide or sitagliptin does not affect hepatic fat in type 2 diabetes: a randomised placebo-controlled trial. Smits MM, Diabetologia	2016	Randomized trial	PMID 27627981 DOI	cites ClinicalTrials.gov:NCT01744236; registry reference DERIVED:27627981
R0014361	Cardiovascular, renal and gastrointestinal effects of incretin-based therapies: an acute and 12-week randomised, double-blind, placebo-controlled, mechanistic intervention trial in type 2 diabetes. Smits MM, BMJ open	2015	Randomized trial	PMID 26586327 DOI	cites ClinicalTrials.gov:NCT01744236; registry reference DERIVED:26586327