Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)

Merck Sharp & Dohme LLC57 enrolled

Overview

A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus (T2DM)

Interventions

Comparator: sitagliptin phosphateDRUG

Sitagliptin tablet 100 mg, administered once daily before the morning meal.

Comparator: placebo (unspecified)DRUG

Matching placebo tablet, administered once daily before the morning meal.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant has type 2 diabetes mellitus * Males * Females who are highly unlikely to become pregnant * Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications Exclusion Criteria: * Participant has a history of type 1 diabetes mellitus or history of ketoacidosis * Participant required insulin therapy within the prior 8 weeks * Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit

Outcomes

Primary Outcomes

Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6

Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.

Time frame: Baseline and Week 6

Data from ClinicalTrials.gov

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