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Effect of Sitagliptin on Postprandial Lipoprotein Metabolism

This study has been terminated.
(Recruitment failure)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00939939
First Posted: July 15, 2009
Last Update Posted: June 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ludwig-Maximilians - University of Munich
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


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 ]
    incremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge


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

  • HDL-cholesterol [ Time Frame: 10 weeks ]
    fasting HDL-cholesterol

  • VLDL-cholesterol [ Time Frame: 10 weeks ]
    fasting VLDL-cholesterol

  • triglycerides [ Time Frame: 10 weeks ]
    fasting triglycerides

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

  • glucose [ Time Frame: 10 weeks ]
    fasting glucose concentration

  • insulin [ Time Frame: 10 weeks ]
    fasting insulin concentration

  • HOMA [ Time Frame: 10 weeks ]
  • HbA1c [ Time Frame: 10 weeks ]
  • interleukin-6 [ Time Frame: 10 weeks ]
  • hs-CRP [ Time Frame: 10 weeks ]

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

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: July 14, 2009
First Posted: July 15, 2009
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