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

Merck Sharp & Dohme LLC25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

VildagliptinDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

24 Hour Weighted Mean Glucose (WMG) At 2 Weeks

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.

Time frame: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment

Secondary Outcomes

Hemoglobin A1C (HbA1C) At 2 Weeks

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 (%).

Time frame: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment

HbA1C At 12 Weeks

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 (%).

Time frame: At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.