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

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ClinicalTrials.gov Identifier: NCT01537120
Recruitment Status : Completed
First Posted : February 23, 2012
Results First Posted : December 3, 2013
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Vildagliptin Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Evaluation of Continuous Glucose Monitoring as a Tool to Measure Glucoregulatory Effects of a Twice Daily Oral Insulin Secretagogue
Study Start Date : December 2011
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Hemoglobin A1C (HbA1C) At 2 Weeks [ Time Frame: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment ]
    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 (%).

  2. HbA1C At 12 Weeks [ Time Frame: At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment ]
    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 (%).


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01537120     History of Changes
Other Study ID Numbers: 0000-258
First Posted: February 23, 2012    Key Record Dates
Results First Posted: December 3, 2013
Last Update Posted: August 19, 2015
Last Verified: August 2015

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