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Effect of Sitagliptin on Postprandial Lipoprotein Metabolism

This study has been terminated.
(Recruitment failure)
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00939939
First received: July 14, 2009
Last updated: June 24, 2011
Last verified: July 2009
History of Changes
  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 4

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:

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 May 19, 2013