Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: AC2993

Study type: Interventional

Funder types: Industry

Identifiers

NCT00044668

2993-117

Details and patient eligibility

About

This multi-center, open-label study is designed to examine the effects on long-term glucose control and safety of AC2993 in patients with type 2 diabetes treated with metformin, sulfonylurea, or metformin and sulfonylurea combination.

Enrollment: 155 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with type 2 diabetes
• Treated for at least 3 months prior to screening either with metformin, sulfonylurea, or metformin and sulfonylurea combination
• BMI 25-45 kg/m^2
• HbA1c between 7.5 % and 12.0 %, inclusive

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

155 participants in 1 patient group

AC2993

Experimental group

Description:

5 μg AC2993, twice daily, for 4 weeks followed by 10 μg AC2993, twice daily, during a maintenance period

Treatment:

Drug: AC2993