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

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Non-Insulin-Dependent	Drug: Placebo 0.01 mL Drug: Placebo 0.02 mL Drug: Placebo 0.03 mL Drug: Placebo 0.04 mL Drug: AC2993 2.5 mcg Drug: AC2993 5.0 mcg Drug: AC2993 7.5 mcg Drug: AC2993 10.0 mcg	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Short-Term, Dose-Response Study to Examine the Effect on Glucose Control and Safety and Tolerability of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Exenatide

U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, LLC.:

Primary Outcome Measures:

Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28 [ Time Frame: Baseline (Day 1) to Day 28 ] [ Designated as safety issue: No ]
Change in HbA1c from Baseline (Day 1) to study termination (Day 28)

Secondary Outcome Measures:

Change in HbA1c from Baseline to Day 14 [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
Change in HbA1c from Baseline (Day 1) to Day 14
Change in fasting plasma glucose from Baseline to Day 14 and to Day 28 [ Time Frame: Baseline, Day 14, Day28 ] [ Designated as safety issue: No ]
Change in fasting plasma glucose from Baseline (Day 1) to Day 14 and to study termination (Day 28)
Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28 [ Time Frame: Baseline, Day 14, Day 28 ] [ Designated as safety issue: No ]
Change in serum fructosamine from baseline (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)

Enrollment:	156
Study Start Date:	August 2002
Study Completion Date:	May 2003
Primary Completion Date:	May 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo 0.01 mL 2 week placebo lead-in followed by Placebo 0.01 mL	Drug: Placebo 0.01 mL 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily
Placebo Comparator: Placebo 0.02 mL 2 week placebo lead-in followed by Placebo 0.02 mL	Drug: Placebo 0.02 mL 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily
Placebo Comparator: Placebo 0.03 mL 2 week placebo lead-in followed by Placebo 0.03 mL	Drug: Placebo 0.03 mL 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily
Placebo Comparator: Placebo 0.04 mL 2 week placebo lead-in followed by Placebo 0.04 mL	Drug: Placebo 0.04 mL 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily
Experimental: AC2993 2.5 mcg 2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL	Drug: AC2993 2.5 mcg 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily Other Name: synthetic exendin-4
Experimental: AC2993 5.0 mcg 2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL	Drug: AC2993 5.0 mcg 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily Other Name: synthetic exendin-4
Experimental: AC2993 7.5 mcg 2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL	Drug: AC2993 7.5 mcg 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily Other Name: synthetic exendin-4
Experimental: AC2993 10.0 mcg 2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL	Drug: AC2993 10.0 mcg 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily Other Name: synthetic exendin-4

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044694

Show 33 Study Locations

Sponsors and Collaborators

Amylin Pharmaceuticals, LLC.

More Information

No publications provided by Amylin Pharmaceuticals, LLC.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nelson P, Poon T, Guan X, Schnabel C, Wintle M, Fineman M. The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes. Diabetes Technol Ther. 2007 Aug;9(4):317-26.

Responsible Party:	Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:	NCT00044694 History of Changes
Other Study ID Numbers:	2993-116
Study First Received:	September 3, 2002
Last Updated:	February 5, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, LLC.:

Diabetes Mellitus, Type 2

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013