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Effect of Sitagliptin on Postprandial Lipoprotein Metabolism

Primary Purpose

Diabetes Mellitus Type 2

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
sitagliptin
glimepiride
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • type 2 diabetes
  • dietary therapy

Exclusion Criteria:

  • lipid-lowering therapy
  • anti-hyperglycemic drug therapy

Sites / Locations

  • Medical Dept. 2, Grosshadern, University Munich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sitagliptin

glimepirid

Arm Description

Outcomes

Primary Outcome Measures

incremental area under the triglyceride curve (iAUC-TG)
incremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge

Secondary Outcome Measures

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

Full Information

First Posted
July 14, 2009
Last Updated
June 24, 2011
Sponsor
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT00939939
Brief Title
Effect of Sitagliptin on Postprandial Lipoprotein Metabolism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Terminated
Why Stopped
Recruitment failure
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ludwig-Maximilians - University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sitagliptin
Arm Type
Experimental
Arm Title
glimepirid
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
sitagliptin
Intervention Description
sitagliptin 100 mg/d for 10 weeks
Intervention Type
Drug
Intervention Name(s)
glimepiride
Intervention Description
glimepiride 1 mg/d for 10 weeks
Primary Outcome Measure Information:
Title
incremental area under the triglyceride curve (iAUC-TG)
Description
incremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
LDL-cholesterol
Description
fasting LDL-cholesterol
Time Frame
10 weeks
Title
HDL-cholesterol
Description
fasting HDL-cholesterol
Time Frame
10 weeks
Title
VLDL-cholesterol
Description
fasting VLDL-cholesterol
Time Frame
10 weeks
Title
triglycerides
Description
fasting triglycerides
Time Frame
10 weeks
Title
area under the triglyceride curve (AUC-TG)
Description
area under the plasma triglyceride concentration curve following a standardized oral fat challenge
Time Frame
10 weeks
Title
area under the VLDL-triglyceride curve (AUC-VLDL-TG)
Description
area under the plasma VLDL-triglyceride concentration curve following a standardized oral fat challenge
Time Frame
10 weeks
Title
incremental area under the VLDL-triglyceride curve (iAUC-VLDL-TG)
Description
incremental area under the plasma VLDL-triglyceride concentration curve following a standardized oral fat challenge
Time Frame
10 weeks
Title
glucose
Description
fasting glucose concentration
Time Frame
10 weeks
Title
insulin
Description
fasting insulin concentration
Time Frame
10 weeks
Title
HOMA
Time Frame
10 weeks
Title
HbA1c
Time Frame
10 weeks
Title
interleukin-6
Time Frame
10 weeks
Title
hs-CRP
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: type 2 diabetes dietary therapy Exclusion Criteria: lipid-lowering therapy anti-hyperglycemic drug therapy
Facility Information:
Facility Name
Medical Dept. 2, Grosshadern, University Munich
City
Munich
ZIP/Postal Code
81377
Country
Germany

12. IPD Sharing Statement

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Effect of Sitagliptin on Postprandial Lipoprotein Metabolism

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