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Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes
This study has been completed.
Sponsor:
AstraZeneca
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00103935
First received: February 17, 2005
Last updated: February 23, 2015
Last verified: January 2015
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Purpose
Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus.
| Condition | Intervention | Phase |
|---|---|---|
| Type 2 Diabetes Mellitus | Drug: placebo Drug: Exenatide LAR | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine Safety and Pharmacokinetics of Exenatide Long-Acting Release Administered Weekly in Subjects With Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Assess the safety, tolerability, and pharmacokinetics of exenatide long-acting release (LAR) administered weekly by subcutaneous (SC) injection in subjects with type 2 diabetes (T2DM) [ Time Frame: Time intervals: 0 min to 12 hours on Day 1 for a duration of 12 hours, from Day 1; 0 mininutes to Week 1 for a duration of 168 hours, and from Week 14 to Week 15 for a duration of 168 hours ]
Secondary Outcome Measures:
- Examine the effect on various pharmacodynamic parameters of exenatide LAR administered weekly by subcutaneous injection in subjects with Type 2 Diabetes Mellitus [ Time Frame: Various time intervals from Day 1 to Week 15 ]
- Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27). [ Time Frame: Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27 ]Change in HbA1c from baseline Visit 3 (Day -3) to Visit 25 (Week 15) and to each intermediate visit where applicable, and to study termination.
- Change in fasting glucose concentrations from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27) [ Time Frame: Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27 ]Change in fasting glucose concentrations from baseline Visit 3 (Day -3) to Visit 25 (Week 15) and to each intermediate visit where applicable, and to study termination
- Change in body weight from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27) [ Time Frame: Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27 ]Change in body weight (kg) from baseline Visit 3 (Day -3) to Visit 25 (Week 15) and to each intermediate visit where applicable, and to study termination
- Change in seven-point glucose concentrations from Baseline to Week 14 and Week 15 [ Time Frame: Baseline, 3 days between Day -7 and Day -3, and 3 days between Week 14 and Week 15 ]Change in seven-point glucose concentrations from baseline (collected on 3 days between Visit 2 [Day -7] and Visit 3 [Day -3]) to Visit 25 (collected on 3 days between Visit 20 [Week 14] and Visit 25 [Week 15])
| Enrollment: | 45 |
| Study Start Date: | February 2005 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Group A1
Placebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR
|
Drug: placebo
Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg
|
|
Placebo Comparator: Group A2
Placebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR
|
Drug: placebo
Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 2.0 mcg
|
|
Experimental: Group B
Exenatide lead-in followed by exenatide LAR 0.8 mg weekly
|
Drug: Exenatide LAR
Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg.
Other Name: Bydureon
|
|
Experimental: Group C
Exenatide lead-in followed by exenatide LAR 2.0 mg weekly
|
Drug: Exenatide LAR
Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 2.0 mcg.
Other Name: Bydureon
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Has type 2 diabetes treated with either: *A stable regimen of metformin for a minimum of 3 months, and/or *Diet modification and exercise for a minimum of 3 months.
- Has HbA1c of 7.1% to 11.0%, inclusive.
- Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.
Exclusion Criteria:
- Received any investigational drug within 3 months prior to screening.
- Is currently treated with any of the following excluded medications: *Thiazolidinediones within 3 months of screening; * Sulfonylureas within 3 months of screening; * Insulin within 1 year of screening.
- Participated previously in an exenatide clinical study.
Contacts and Locations
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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: NCT00103935
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103935
Locations
| United States, California | |
| Research Site | |
| Walnut Creek, California, United States | |
| United States, Hawaii | |
| Research Site | |
| Honolulu, Hawaii, United States | |
| United States, Missouri | |
| Research Site | |
| St. Louis, Missouri, United States | |
| United States, Montana | |
| Research Site | |
| Butte, Montana, United States | |
| United States, Oregon | |
| Research Site | |
| Portland, Oregon, United States | |
| United States, Texas | |
| Research Site | |
| San Antonio, Texas, United States | |
| United States, Washington | |
| Research Site | |
| Olympia, Washington, United States | |
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
| Study Director: | Lisa Porter, MD | Amylin Pharmaceuticals, LLC. |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00103935 History of Changes |
| Other Study ID Numbers: |
2993LAR-104 |
| Study First Received: | February 17, 2005 |
| Last Updated: | February 23, 2015 |
Keywords provided by AstraZeneca:
|
diabetes exenatide long acting release 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 |
ClinicalTrials.gov processed this record on July 26, 2017