Phase 1
Completed N=25
Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)
Source: ClinicalTrials.gov NCT01537120 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: 24 Hour Weighted Mean Glucose (WMG) At 2 Weeks — 126.9; 114.2 mg/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24 Hour Weighted Mean Glucose (WMG) At 2 Weeks |
126.9; 114.2 | — |
| SECONDARY Hemoglobin A1C (HbA1C) At 2 Weeks |
7.12; 6.82 | — |
| SECONDARY HbA1C At 12 Weeks |
7.12; 6.66 | — |
Eligibility 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 = 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.
Data sourced from ClinicalTrials.gov (NCT01537120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.