Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Comparator: Placebo; Drug: Comparator: Pioglitazone; Drug: Comparator: Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00106704

0431-035

2005_009

Details and patient eligibility

About

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.

Enrollment: 441 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Type 2 Diabetes Mellitus with inadequate glycemic control

Exclusion criteria

• Patients with Type 1 Diabetes Mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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441 participants in 2 patient groups, including a placebo group

Sitagliptin

Experimental group

Description:

Sitagliptin 10 mg tablet daily for 54 weeks

Treatment:

Drug: Comparator: Sitagliptin

Placebo/ Pioglitazone

Placebo Comparator group

Description:

Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks

Treatment:

Drug: Comparator: Pioglitazone

Drug: Comparator: Placebo