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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00044694
First received: September 3, 2002
Last updated: June 4, 2014
Last verified: June 2014
  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:


Further study details as provided by AstraZeneca:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 33 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00044694     History of Changes
Other Study ID Numbers: 2993-116
Study First Received: September 3, 2002
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 20, 2014