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Effect of Sitagliptin on Postprandial Lipoprotein Metabolism

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ClinicalTrials.gov Identifier: NCT00939939
Recruitment Status : Terminated (Recruitment failure)
First Posted : July 15, 2009
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: sitagliptin Drug: glimepiride Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. LDL-cholesterol [ Time Frame: 10 weeks ]
    fasting LDL-cholesterol

  2. HDL-cholesterol [ Time Frame: 10 weeks ]
    fasting HDL-cholesterol

  3. VLDL-cholesterol [ Time Frame: 10 weeks ]
    fasting VLDL-cholesterol

  4. triglycerides [ Time Frame: 10 weeks ]
    fasting triglycerides

  5. area under the triglyceride curve (AUC-TG) [ Time Frame: 10 weeks ]
    area under the plasma triglyceride concentration curve following a standardized oral fat challenge

  6. 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

  7. 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

  8. glucose [ Time Frame: 10 weeks ]
    fasting glucose concentration

  9. insulin [ Time Frame: 10 weeks ]
    fasting insulin concentration

  10. HOMA [ Time Frame: 10 weeks ]
  11. HbA1c [ Time Frame: 10 weeks ]
  12. interleukin-6 [ Time Frame: 10 weeks ]
  13. hs-CRP [ Time Frame: 10 weeks ]


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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes
  • dietary therapy

Exclusion Criteria:

  • lipid-lowering therapy
  • anti-hyperglycemic drug therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939939


Locations
Germany
Medical Dept. 2, Grosshadern, University Munich
Munich, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich

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
First Posted: July 15, 2009    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: July 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors