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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sitagliptin
Glimepiride
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 18, 2014