Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes
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
1 other identifier
interventional
45
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes-mellitus
Started Feb 2005
Shorter than P25 for phase_2 type-2-diabetes-mellitus
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 17, 2005
CompletedFirst Posted
Study publicly available on registry
February 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFebruary 24, 2015
January 1, 2015
8 months
February 17, 2005
February 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 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 Outcomes (5)
Examine the effect on various pharmacodynamic parameters of exenatide LAR administered weekly by subcutaneous injection in subjects with Type 2 Diabetes Mellitus
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).
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 to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27)
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 from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27)
Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27
Change in seven-point glucose concentrations from Baseline to Week 14 and Week 15
Baseline, 3 days between Day -7 and Day -3, and 3 days between Week 14 and Week 15
Study Arms (4)
Group A1
PLACEBO COMPARATORPlacebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR
Group A2
PLACEBO COMPARATORPlacebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR
Group B
EXPERIMENTALExenatide lead-in followed by exenatide LAR 0.8 mg weekly
Group C
EXPERIMENTALExenatide lead-in followed by exenatide LAR 2.0 mg weekly
Interventions
Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg
Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (7)
Research Site
Walnut Creek, California, United States
Research Site
Honolulu, Hawaii, United States
Research Site
St Louis, Missouri, United States
Research Site
Butte, Montana, United States
Research Site
Portland, Oregon, United States
Research Site
San Antonio, Texas, United States
Research Site
Olympia, Washington, United States
Related Publications (1)
Fineman M, Flanagan S, Taylor K, Aisporna M, Shen LZ, Mace KF, Walsh B, Diamant M, Cirincione B, Kothare P, Li WI, MacConell L. Pharmacokinetics and pharmacodynamics of exenatide extended-release after single and multiple dosing. Clin Pharmacokinet. 2011 Jan;50(1):65-74. doi: 10.2165/11585880-000000000-00000.
PMID: 21142268DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisa Porter, MD
Amylin Pharmaceuticals, LLC.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2005
First Posted
February 18, 2005
Study Start
February 1, 2005
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
February 24, 2015
Record last verified: 2015-01