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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):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00085969
First received: June 18, 2004
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Placebo 0.04 mL twice daily
Drug: Placebo 0.04 mL once daily
Drug: Placebo 0.08 mL once daily
Drug: B - Exenatide 10 mcg twice daily
Drug: C - Exenatide 10 mcg once daily
Drug: Exenatide 20 mcg once daily
 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, Multicenter Study to Examine the Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

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 28 ] [ Designated as safety issue: No ]
    Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28)


Secondary Outcome Measures:
  • 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)


Enrollment: 99
Study Start Date: September 2003
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A1 - Placebo 0.04 mL twice daily Drug: Placebo 0.04 mL twice daily
Subcutaneously injected, 0.04 mL, twice daily
Placebo Comparator: A2 - Placebo 0.04 mL once daily Drug: Placebo 0.04 mL once daily
Subcutaneously injected, 0.04 mL, once daily
Placebo Comparator: A3 - Placebo 0.08 mL once daily Drug: Placebo 0.08 mL once daily
Subcutaneously injected, 0.08 mL, once daily
Experimental: B - Exenatide 10 mcg twice daily Drug: B - Exenatide 10 mcg twice daily
Subcutaneously injected, 10 mcg (0.04 mL), twice daily
Other Names:
  • ACC2993
  • synthetic exendin-4
Experimental: C - Exenatide 10 mcg once daily Drug: C - Exenatide 10 mcg once daily
Subcutaneously injected, 10 mcg (0.04 mL), once daily
Other Names:
  • ACC2993
  • synthetic exendin-4
Experimental: D - Exenatide 20 mcg once daily Drug: Exenatide 20 mcg once daily
Subcutaneously injected, 20 mcg (0.08 mL), once daily
Other Names:
  • ACC2993
  • synthetic exendin-4

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085969

  Show 23 Study Locations
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
  More Information

No publications provided by Amylin Pharmaceuticals, LLC.

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

Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT00085969     History of Changes
Other Study ID Numbers: 2993-120
Study First Received: June 18, 2004
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, LLC.:
diabetes
exenatide
Amylin
Lilly

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