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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Non-Insulin-Dependent
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Innovative Clinical Trials
    • Birmingham, Alabama, United States, 35243
      • Healthsouth Clinical Research
  • California
    • Anaheim, California, United States, 92801
      • Endocrinology Clinic of O.C.
    • Bellflower, California, United States, 90706
      • Pioneer Medical Group
    • Chula Vista, California, United States, 91910
      • International Clinical Research Network
    • Fresno, California, United States, 93721
      • Bautista Research and Medical Clinic
    • La Jolla, California, United States, 92037
      • Whittier Institute for Diabetes
    • Los Gatos, California, United States, 95032
      • Richard Cherlin, M.D.
    • Moreno Valley, California, United States, 92553
      • Dr. Martinez Medical Clinic
  • Colorado
    • Aurora, Colorado, United States, 80010
      • Anshutz Outpatient Pavilion
  • Florida
    • Clearwater, Florida, United States, 33760
      • Diagnostic Clinic
    • Gainsville, Florida, United States, 32605
      • Radiant Research-Gainsville
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Pinellas Park, Florida, United States, 33781
      • Radiant Research-Pinellas Park
  • Georgia
    • Blairsville, Georgia, United States, 30512
      • Clinical Research Group of North Georgia
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • East-West Medical Research Institute
    • Honolulu, Hawaii, United States, 96814
      • Radiant Research-Honolulu
  • Idaho
    • Boise, Idaho, United States, 83704
      • Radiant Research-Boise
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Cedar-Crosse Research Center
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Northshore Medical Research, LLC
    • Slidell, Louisiana, United States, 70458
      • Medical Research Institute
  • Massachusetts
    • Concord, Massachusetts, United States, 01742
      • Melvin Kramer, MD
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Radiant Research-Edina
  • Mississippi
    • Gulfport, Mississippi, United States, 39501
      • Mississippi Medical Research, LLC
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Innovative Health Research
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • Carolina Advanced Research
  • Ohio
    • Maumee, Ohio, United States, 43537
      • Fallen Timbers Internal Medicine, LLC
  • Texas
    • Benbrook, Texas, United States, 76126
      • Millenium Research
    • Desoto, Texas, United States, 75115
      • Healthsouth Clinical Research
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine/Clinical Studies Unit
    • Midland, Texas, United States, 79705
      • Diabetes Center of the Southwest
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • Utah Diabetes Center at the University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: synthetic exendin-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28	Change in HbA1c from Baseline (Day 1) to study termination (Day 28)	Baseline (Day 1) to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c from Baseline to Day 14	Change in HbA1c from Baseline (Day 1) to Day 14	Baseline, Day 14
Change in fasting plasma glucose from Baseline to Day 14 and to Day 28	Change in fasting plasma glucose from Baseline (Day 1) to Day 14 and to study termination (Day 28)	Baseline, Day 14, Day28
Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28	Change in serum fructosamine from baseline (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)	Baseline, Day 14, Day 28

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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. doi: 10.1089/dia.2006.0024.

Study record dates

Study Major Dates

• Study Start: August 1, 2002
• Primary Completion (Actual): May 1, 2003
• Study Completion (Actual): May 1, 2003

Study Registration Dates

• First Submitted: September 3, 2002
• First Submitted That Met QC Criteria: September 4, 2002
• First Posted (Estimate): September 5, 2002

Study Record Updates

• Last Update Posted (Estimate): February 20, 2015
• Last Update Submitted That Met QC Criteria: February 19, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Diabetes Mellitus, Type 2
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Exenatide
• Other Study ID Numbers: 2993-116