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Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00085969
First received: June 18, 2004
Last updated: June 4, 2014
Last verified: June 2014

June 18, 2004
June 4, 2014
September 2003
January 2004   (final data collection date for primary outcome measure)
Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28 [ Time Frame: Baseline, Day 28 ] [ Designated as safety issue: No ]
Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28)
Not Provided
Complete list of historical versions of study NCT00085969 on ClinicalTrials.gov Archive Site
  • Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28 [ Time Frame: Baseline, Day 14, Day 28 ] [ Designated as safety issue: No ]
    Change in serum fructosamine concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
  • Change in body weight from Baseline to Day 14 and to Day 28 [ Time Frame: Baseline, Day 14, Day28 ] [ Designated as safety issue: No ]
    Change in body weight from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
  • Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28 [ Time Frame: Baseline, Day 14, Day 28 ] [ Designated as safety issue: No ]
    Change in fasting plasma glucose concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
  • Change in postprandial blood glucose concentrations from Baseline to Day 28 [ Time Frame: Baseline, Week 28 ] [ Designated as safety issue: No ]
    Change in postprandial blood glucose concentrations from Baseline Visit 3 (Day 1) to study termination (Day 28)
Not Provided
Not Provided
Not Provided
 
Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus
A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo 0.04 mL twice daily
    Subcutaneously injected, 0.04 mL, twice daily
  • Drug: Placebo 0.04 mL once daily
    Subcutaneously injected, 0.04 mL, once daily
  • Drug: Placebo 0.08 mL once daily
    Subcutaneously injected, 0.08 mL, once daily
  • Drug: B - Exenatide 10 mcg twice daily
    Subcutaneously injected, 10 mcg (0.04 mL), twice daily
    Other Names:
    • ACC2993
    • synthetic exendin-4
  • Drug: C - Exenatide 10 mcg once daily
    Subcutaneously injected, 10 mcg (0.04 mL), once daily
    Other Names:
    • ACC2993
    • synthetic exendin-4
  • Drug: Exenatide 20 mcg once daily
    Subcutaneously injected, 20 mcg (0.08 mL), once daily
    Other Names:
    • ACC2993
    • synthetic exendin-4
  • Placebo Comparator: A1 - Placebo 0.04 mL twice daily
    Intervention: Drug: Placebo 0.04 mL twice daily
  • Placebo Comparator: A2 - Placebo 0.04 mL once daily
    Intervention: Drug: Placebo 0.04 mL once daily
  • Placebo Comparator: A3 - Placebo 0.08 mL once daily
    Intervention: Drug: Placebo 0.08 mL once daily
  • Experimental: B - Exenatide 10 mcg twice daily
    Intervention: Drug: B - Exenatide 10 mcg twice daily
  • Experimental: C - Exenatide 10 mcg once daily
    Intervention: Drug: C - Exenatide 10 mcg once daily
  • Experimental: D - Exenatide 20 mcg once daily
    Intervention: Drug: Exenatide 20 mcg once daily
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
January 2004
January 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject has type 2 diabetes mellitus treated with diet and exercise modification alone or in combination with one oral antidiabetic agent for no longer than 4 years.

Exclusion Criteria:

  • Subject has a clinically significant history or presence of any of the following conditions: (a) Hepatic disease, (b) Renal disease, (c) Central nervous system disease, (d) Gastrointestinal disease (e) Pulmonary disease (f) Hematologic disease.
  • Subject is currently treated with any of the following excluded medications: (a) Metformin/sulfonylurea combination therapy (b) Thiazolidinediones (c) Insulin as outpatient therapy (d) Regular use of drugs that directly affect gastrointestinal motility (e) Regular use of systemic corticosteroids by oral, intravenous (IV), or intramuscular (IM) route, or potent, inhaled, intrapulmonary, or intranasal steroids known to have a high rate of systemic absorption (f) Regular use of medications with addictive potential such as opiates, narcotics and tranquilizers (g) Antineoplastic agents (h) Transplantation medications (i) Prescription weight-loss medications.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00085969
2993-120
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Not Provided
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP