A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Sitagliptin; Drug: MK-0893; Drug: Placebo for Sitagliptin; Drug: Placebo for MK-0893; Drug: Placebo for Metformin; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00631488

0893-015

2007_646

Details and patient eligibility

About

This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.

Enrollment: 146 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy

Exclusion criteria

• Participants have a history of Type 1 Diabetes Mellitus
• Participants taking insulin or thiazolidinediones (TZDs: peroxisome proliferator-activated receptor [PPAR]-gamma agonists)
• Participants who have a contraindication to metformin or sitagliptin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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146 participants in 3 patient groups

MK-0893 + Sitagliptin

Experimental group

Treatment:

Drug: Placebo for Metformin

Drug: MK-0893

Drug: Sitagliptin

MK-0893 + Metformin

Experimental group

Treatment:

Drug: Metformin

Drug: MK-0893

Drug: Placebo for Sitagliptin

Sitagliptin + Metformin

Active Comparator group

Treatment:

Drug: Metformin

Drug: Placebo for MK-0893

Drug: Sitagliptin