Study Of Denagliptin In Subjects With Type 2 Diabetes Mellitus (T2DM)

GlaxoSmithKline (GSK)

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: denagliptin (GW823093)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00387972

DPB107246

Details and patient eligibility

About

GW823093 is a selective DPP-IV Inhibitor and is being investigated as a once a day oral therapy. The purpose of the Study is to evaluate the effectiveness, safety, and tolerability of 2 doses of GW823093, compared to placebo, taken once daily in patients with Type 2 diabetes mellitus.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus treated with diet and exercise or oral anti-diabetic treatment
• Body mass index between 20 and 40
• Females of childbearing potential must use adequate birth control.

Exclusion criteria

• Subjects with previous use of insulin
• Type 1 diabetes
• Uncontrolled thyroid disease
• History of drug or alcohol abuse in the past year
• Any other clinically significant disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind