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

GlaxoSmithKline

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Type 2 Diabetes Mellitus

Interventions

denagliptin (GW823093)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (57)

Outcomes

Primary Outcomes

Change from baseline in blood glucose regulation after 26 weeks of treatment

Secondary Outcomes

Change from baseline in glycemic parameters, insulin, body weight and waist circumference, and safety measures

Data from ClinicalTrials.gov

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