Effect of Sitagliptin on Postprandial Lipoprotein Metabolism - Full Text View

Sponsor:	Ludwig-Maximilians - University of Munich
Information provided by:	Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00939939

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus Type 2	Drug: sitagliptin Drug: glimepiride	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Glimepiride Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:

incremental area under the triglyceride curve (iAUC-TG) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
incremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge

Secondary Outcome Measures:

LDL-cholesterol [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
fasting LDL-cholesterol
HDL-cholesterol [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
fasting HDL-cholesterol
VLDL-cholesterol [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
fasting VLDL-cholesterol
triglycerides [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
fasting triglycerides
area under the triglyceride curve (AUC-TG) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
area under the plasma triglyceride concentration curve following a standardized oral fat challenge
area under the VLDL-triglyceride curve (AUC-VLDL-TG) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
area under the plasma VLDL-triglyceride concentration curve following a standardized oral fat challenge
incremental area under the VLDL-triglyceride curve (iAUC-VLDL-TG) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
incremental area under the plasma VLDL-triglyceride concentration curve following a standardized oral fat challenge
glucose [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
fasting glucose concentration
insulin [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
fasting insulin concentration
HOMA [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
interleukin-6 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
hs-CRP [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment:	3
Study Start Date:	March 2010
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: sitagliptin	Drug: sitagliptin sitagliptin 100 mg/d for 10 weeks
Active Comparator: glimepirid	Drug: glimepiride glimepiride 1 mg/d for 10 weeks

Eligibility

Ages Eligible for Study:	19 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

type 2 diabetes
dietary therapy

Exclusion Criteria:

lipid-lowering therapy
anti-hyperglycemic drug therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939939

Locations

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

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

More Information

No publications provided

Responsible Party:	Prof. Klaus Parhofer, Med. Dept. 2 University Munich
ClinicalTrials.gov Identifier:	NCT00939939 History of Changes
Other Study ID Numbers:	KP MSD 01-08
Study First Received:	July 14, 2009
Last Updated:	June 24, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Sitagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012