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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2005-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AC2993

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

Group Type EXPERIMENTAL

AC2993

Intervention Type DRUG

Subjects will receive 5 μg AC2993, subcutaneously injected twice daily, for 4 weeks followed by 10 μg AC2993, subcutaneously injected twice daily, during a maintenance period that is expected to continue for at least 11 months.

Interventions

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AC2993

Subjects will receive 5 μg AC2993, subcutaneously injected twice daily, for 4 weeks followed by 10 μg AC2993, subcutaneously injected twice daily, during a maintenance period that is expected to continue for at least 11 months.

Intervention Type DRUG

Other Intervention Names

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synthetic exendin-4

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No