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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: September 26, 2014
Last verified: September 2014

December 22, 2011
September 26, 2014
December 2011
October 2012   (final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT01537120 on ClinicalTrials.gov Archive Site
  • 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 (%).
  • 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 ]
Not Provided
Not Provided
 
Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)
Evaluation of Continuous Glucose Monitoring as a Tool to Measure Glucoregulatory Effects of a Twice Daily Oral Insulin Secretagogue

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Type 2 Diabetes Mellitus
  • Drug: Vildagliptin
  • Drug: Placebo
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
Interventions:
  • Drug: Vildagliptin
  • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01537120
0000-258
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP