Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Treatments: Drug: AC2993; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00035984

2993-115

Details and patient eligibility

About

This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin and a sulfonylurea) throughout the study.

Enrollment: 734 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with Type 2 diabetes mellitus
• Treated with both metformin and a sulfonylurea at defined doses for at least 3 months prior to screening
• BMI= 27-45 kg/m2
• HbA1c value between 7.5% and 11%

Exclusion criteria

• Treated with oral anti-diabetic medications other than metformin and sulfonylurea within 3 months of screening
• Patients treated previously with AC2993
• Patients presently treated with insulin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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734 participants in 4 patient groups, including a placebo group

AC2993 5 mcg (0.02 mL)

Experimental group

Description:

Placebo, then AC2993 5 mcg, then AC2993 5 mcg

Treatment:

Drug: AC2993

Drug: AC2993

AC2993 10mcg (0.04 mL)

Experimental group

Description:

Placebo, then AC2993 5 mcg, then AC2993 10 mcg

Treatment:

Drug: AC2993

Drug: AC2993

Placebo 0.02 mL

Placebo Comparator group

Description:

Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL

Treatment:

Drug: Placebo

Drug: Placebo

Placebo 0.04 mL

Placebo Comparator group

Description:

Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL

Treatment:

Drug: Placebo

Drug: Placebo