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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Treatments: Drug: AC2993 10.0 mcg; Drug: Placebo 0.03 mL; Drug: AC2993 5.0 mcg; Drug: AC2993 7.5 mcg; Drug: Placebo 0.01 mL; Drug: Placebo 0.04 mL; Drug: AC2993 2.5 mcg; Drug: Placebo 0.02 mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00044694

2993-116

Details and patient eligibility

About

This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Patients whose diabetes management consists of diet and exercise will also be eligible for this study.

Enrollment: 156 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with type 2 diabetes
• Treated with diet and exercise alone or with metformin for at least 3 months prior to screening
• BMI 27-45 kg/m^2
• HbA1c between 7.0 % and 8.0 %

Exclusion criteria

• Treated with other oral anti-diabetic agents other than metformin within 3 months of screening
• Patients previously treated 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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156 participants in 8 patient groups, including a placebo group

Placebo 0.01 mL

Placebo Comparator group

Description:

2 week placebo lead-in followed by Placebo 0.01 mL

Treatment:

Drug: Placebo 0.01 mL

Placebo 0.02 mL

Placebo Comparator group

Description:

2 week placebo lead-in followed by Placebo 0.02 mL

Treatment:

Drug: Placebo 0.02 mL

Placebo 0.03 mL

Placebo Comparator group

Description:

2 week placebo lead-in followed by Placebo 0.03 mL

Treatment:

Drug: Placebo 0.03 mL

Placebo 0.04 mL

Placebo Comparator group

Description:

2 week placebo lead-in followed by Placebo 0.04 mL

Treatment:

Drug: Placebo 0.04 mL

AC2993 2.5 mcg

Experimental group

Description:

2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL

Treatment:

Drug: AC2993 2.5 mcg

AC2993 5.0 mcg

Experimental group

Description:

2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL

Treatment:

Drug: AC2993 5.0 mcg

AC2993 7.5 mcg

Experimental group

Description:

2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL

Treatment:

Drug: AC2993 7.5 mcg

AC2993 10.0 mcg

Experimental group

Description:

2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL

Treatment:

Drug: AC2993 10.0 mcg