Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)
This study has been completed.
Information provided by (Responsible Party):
First received: December 22, 2011
Last updated: October 16, 2012
Last verified: October 2012
This trial will attempt to develop the use of Continuous Glucose Monitoring (CGM) as a tool for the evaluation of both new and existing pharmacological treatments for type 2 diabetes, using the twice daily administered dipeptidyl peptidase-4 (DPP4) inhibitor, vildagliptin as a probe.
Type 2 Diabetes Mellitus
||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
||Evaluation of Continuous Glucose Monitoring as a Tool to Measure Glucoregulatory Effects of a Twice Daily Oral Insulin Secretagogue
Primary Outcome Measures:
- Change From Baseline In 24 hour Weighted Mean Glucose (WMG) At 2 Weeks [ Time Frame: Baseline and after 2 weeks of Vildagliptin dosing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change From Baseline In Hemoglobin A1C (A1C) At 2 Weeks [ Time Frame: Baseline and after 2 weeks of Vildagliptin dosing ] [ Designated as safety issue: No ]
- Change From Baseline In Hemoglobin A1C (A1C) At 12 Weeks [ Time Frame: Baseline and after 12 weeks of Vildagliptin dosing ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2012 (Final data collection date for primary outcome measure)
50 mg vildagliptin orally, twice daily for 12 weeks
Placebo orally, twice daily for 3 weeks
|Ages Eligible for Study:
||18 Years to 79 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Clinical diagnosis of type 2 diabetes mellitus on a clinical regimen that is metformin alone, up to a maximum of 3 gram per day, on a background of lifestyle measures, and has a Hemoglobin A1C at screening of > 7%.
- If on antihyperglycemic therapy with both metformin and sulfonylurea with a Screening Visit/Visit 1 Hemoglobin A1C of >= 6.5% and =< 7.5%, should then discontinue sulfonylurea usage and undergo washout of sulfonylurea.
- History of either stroke, chronic seizures or major neurological disorder within the last 6 months.
- Untreated hypertension with a blood pressure of > 160/95 mmHg.
- History of neoplastic disease within the past 5 years.
- History of hypersensitivity to vildagliptin or other DPP4 inhibitors.
- Had major surgery, or donated or lost 1 unit (500 mL) of blood, or participated in another investigational study within 4 weeks prior to screen.
- Used any illicit drug or abusively used alcohol within the past 3 months.
No Contacts or Locations Provided
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 22, 2011
||October 16, 2012
||Netherlands: Independent Ethics Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 22, 2013
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs