Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT00111540 |
Recruitment Status
:
Completed
First Posted
: May 24, 2005
Last Update Posted
: February 23, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: exenatide | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 456 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes Mellitus |
Study Start Date : | November 2002 |
Actual Primary Completion Date : | September 2006 |
Actual Study Completion Date : | September 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Exenatide
Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination
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Drug: exenatide
subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination
Other Names:
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- Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ]Change in HbA1c from Visit 1 to each visit up to open-ended study termination
- Change in body weight from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ]Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination
- Change in fasting plasma glucose from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ]Change in fasting plasma glucose from Visit 1 to each visit up to open-ended study termination
- Change in lipids from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ]Change in lipids from Visit 1 to each visit up to open-ended study termination

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The subject has an HbA1c value <=11.0%
- The subject has a body mass index (BMI) of 25 kg/m^2 to 45 kg/m^2, inclusive
Exclusion Criteria:
- Is currently treated with certain medications, including exogenous insulin

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): NCT00111540

Study Director: | Lisa Porter, MD | Amylin Pharmaceuticals, LLC. |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00111540 History of Changes |
Other Study ID Numbers: |
2993-119 |
First Posted: | May 24, 2005 Key Record Dates |
Last Update Posted: | February 23, 2015 |
Last Verified: | January 2015 |
Keywords provided by AstraZeneca:
exenatide diabetes Amylin exendin-4 |
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 |