Effect of Sitagliptin on Postprandial Lipoprotein Metabolism

June 24, 2011 updated by: Ludwig-Maximilians - University of Munich
The goal of the study is to evaluate whether sitagliptin can affect postprandial lipoprotein metabolism in type 2 diabetic patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81377
        • Medical Dept. 2, Grosshadern, University Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • type 2 diabetes
  • dietary therapy

Exclusion Criteria:

  • lipid-lowering therapy
  • anti-hyperglycemic drug therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sitagliptin
Drug: sitagliptin
sitagliptin 100 mg/d for 10 weeks
Active Comparator: glimepirid
Drug: glimepiride
glimepiride 1 mg/d for 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incremental area under the triglyceride curve (iAUC-TG)
Time Frame: 10 weeks
incremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge
10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 14, 2009

First Submitted That Met QC Criteria

July 14, 2009

First Posted (Estimate)

July 15, 2009

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 24, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KP MSD 01-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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