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Sitagliptin on Postprandial Lipoprotein Metabolism in Type 2 Diabetes

NCT00939939Phase 4

Key facts

Status: Terminated
Start: Mar 2010
Primary completion: May 2011
Countries: 1
Sponsor: Ludwig Maximilian University of Munich
Modality: Small Molecules

Drugs: sitagliptin
Conditions: type 2 diabetes mellitus (T2DM)

Overview

Phase 4, randomised trial of sitagliptin in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Ludwig Maximilian University of Munich. Primary endpoint: incremental area under the triglyceride curve at 10 weeks. Started Mar 2010; status: terminated.

Design

2 arms

Study design: Randomized

Sitagliptin
Sitagliptin 100 mg/d
Glimepiride
Glimepiride 1 mg/d

Who it enrols

Patients with type 2 diabetes on dietary therapy, excluding those on lipid-lowering or anti-hyperglycemic drug therapy.

Endpoints

Primary

incremental area under the triglyceride curve10 weeks

Secondary

LDL-cholesterol10 weeks
HDL-cholesterol10 weeks
VLDL-cholesterol10 weeks
triglycerides10 weeks
area under the triglyceride curve10 weeks
area under the VLDL-triglyceride curve10 weeks
incremental area under the VLDL-triglyceride curve10 weeks
glucose10 weeks

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