Effect of Sitagliptin on Postprandial Lipoprotein Metabolism

Phase 4

Terminated

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: sitagliptin; Drug: glimepiride

• Registration Number: NCT00939939
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

The goal of the study is to evaluate whether sitagliptin can affect postprandial lipoprotein metabolism in type 2 diabetic patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-07
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-14
• Study First Posted: 2009-07-15
• Study Start: 2010-03
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2011-06-24
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• type 2 diabetes
• dietary therapy

Exclusion Criteria

• lipid-lowering therapy
• anti-hyperglycemic drug therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sitagliptin	sitagliptin	-
glimepirid	glimepiride	-

Primary Outcome Measures

Name	Time	Method
incremental area under the triglyceride curve (iAUC-TG)	10 weeks	incremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge

Secondary Outcome Measures

Name	Time	Method
LDL-cholesterol	10 weeks	fasting LDL-cholesterol
HDL-cholesterol	10 weeks	fasting HDL-cholesterol
VLDL-cholesterol	10 weeks	fasting VLDL-cholesterol
triglycerides	10 weeks	fasting triglycerides
area under the triglyceride curve (AUC-TG)	10 weeks	area under the plasma triglyceride concentration curve following a standardized oral fat challenge
area under the VLDL-triglyceride curve (AUC-VLDL-TG)	10 weeks	area under the plasma VLDL-triglyceride concentration curve following a standardized oral fat challenge
incremental area under the VLDL-triglyceride curve (iAUC-VLDL-TG)	10 weeks	incremental area under the plasma VLDL-triglyceride concentration curve following a standardized oral fat challenge
glucose	10 weeks	fasting glucose concentration
insulin	10 weeks	fasting insulin concentration
HOMA	10 weeks
HbA1c	10 weeks
interleukin-6	10 weeks
hs-CRP	10 weeks

Trial Locations

Locations (1)

Medical Dept. 2, Grosshadern, University Munich; 🇩🇪 Munich, Germany