Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01537120
First received: December 22, 2011
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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. The primary hypothesis is that two weeks of treatment with 50 mg of oral Vildagliptin, twice daily will lead to a statistically significant decrease in 24 hour weighted-mean glucose (WMG) relative to placebo.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Vildagliptin
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Evaluation of Continuous Glucose Monitoring as a Tool to Measure Glucoregulatory Effects of a Twice Daily Oral Insulin Secretagogue

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 24 Hour Weighted Mean Glucose (WMG) At 2 Weeks [ Time Frame: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment ] [ Designated as safety issue: No ]
    The 24 hour WMG was measured after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment. Glucose was measured over a 24 hour period by having participants wear two continuous glucose monitors (CGM), which produced an average glucose value approximately every 5 minutes. Using these values, the concentration of glucose was calculated from Area Under the Curve 0-24 hours (AUC 0-24hr), and was expressed as 24 hour WMG.


Secondary Outcome Measures:
  • Hemoglobin A1C (HbA1C) At 2 Weeks [ Time Frame: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment ] [ Designated as safety issue: No ]
    Blood samples were taken after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%).

  • HbA1C At 12 Weeks [ Time Frame: At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment ] [ Designated as safety issue: No ]
    Blood samples were taken after 2 weeks of placebo treatment, and again after 12 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%).


Enrollment: 25
Study Start Date: December 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo → Vildagliptin
Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
Drug: Vildagliptin Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01537120     History of Changes
Other Study ID Numbers: 0000-258
Study First Received: December 22, 2011
Results First Received: September 25, 2013
Last Updated: August 26, 2014
Health Authority: Netherlands: Independent Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014