A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Comparator: Sitagliptin phosphate; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00813995

0431-074

2008_601

Details and patient eligibility

About

A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.

Enrollment: 395 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 - 78 years of age
• Currently on metformin monotherapy

Exclusion criteria

• History of Type 1 diabetes mellitus or ketoacidosis
• Currently on a weight loss program and not in the maintenance phase or has started on a weight loss medication within the last 8 weeks
• Has undergone surgery requiring general anesthesia within the past 4 weeks or has planned major surgery
• Currently participating in a study or has participated in a study with or without an investigational compound or device within the past 12 weeks
• History of active liver disease such as chronic active hepatitis B or C, cirrhosis or symptomatic gallbladder disease
• HIV positive
• Pregnant, breast-feeding or planning to become pregnant during the study
• User of recreational or illicit drugs or has a recent history (within the past year) of drug or alcohol abuse or dependence

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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395 participants in 2 patient groups, including a placebo group

Sitagliptin

Experimental group

Treatment:

Drug: Comparator: Sitagliptin phosphate

Placebo

Placebo Comparator group

Treatment:

Drug: Comparator: Placebo