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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00085969
Recruitment Status : Completed
First Posted : June 22, 2004
Last Update Posted : February 23, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2003
Primary Completion Date : January 2004
Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28 [ Time Frame: Baseline, Day 28 ]
    Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28)


Secondary Outcome Measures :
  1. Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28 [ Time Frame: Baseline, Day 14, Day 28 ]
    Change in serum fructosamine concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)

  2. Change in body weight from Baseline to Day 14 and to Day 28 [ Time Frame: Baseline, Day 14, Day28 ]
    Change in body weight from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)

  3. Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28 [ Time Frame: Baseline, Day 14, Day 28 ]
    Change in fasting plasma glucose concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)

  4. Change in postprandial blood glucose concentrations from Baseline to Day 28 [ Time Frame: Baseline, Week 28 ]
    Change in postprandial blood glucose concentrations from Baseline Visit 3 (Day 1) to study termination (Day 28)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085969


  Show 23 Study Locations
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00085969     History of Changes
Other Study ID Numbers: 2993-120
First Posted: June 22, 2004    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: January 2015

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