Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)
|ClinicalTrials.gov Identifier: NCT01537120|
Recruitment Status : Completed
First Posted : February 23, 2012
Results First Posted : December 3, 2013
Last Update Posted : August 19, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|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|
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|
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 ]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 ]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 ]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 (%).
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