Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)

Merck Sharp & Dohme LLC103 enrolled

Overview

A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

103

Conditions

Type 2 Diabetes

Interventions

sitagliptin phosphateDRUG

sitagliptin 100 mg tablets q.d. (once daily) for 7 days.

sitagliptin phosphateDRUG

sitagliptin 200 mg tablets q.d. (once daily) for 7 days.

Comparator: PlaceboDRUG

sitagliptin 100 mg \& 200 mg matching Placebo tablets q.d. (once daily) for 7 days.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has Type 2 Diabetes * Patient is between the ages of 30-65 years * Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin \[A1C\] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%). Exclusion Criteria: * Patient has Type 1 Diabetes * Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months * Patient has taken insulin within the past 3 months

Outcomes

Primary Outcomes

24-hour Weighted Mean Glucose (WMG)

The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.

Time frame: Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.

Data from ClinicalTrials.gov

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