Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: placebo (Drug); placebo (Drug); Exenatide LAR (Drug); Exenatide LAR (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Lisa Porter, MD, Study Director, Affiliation: Amylin Pharmaceuticals, LLC.
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 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)
Secondary outcome: Examine the effect on various pharmacodynamic parameters of exenatide LAR administered weekly by subcutaneous injection in subjects with Type 2 Diabetes MellitusChange in HbA1c (glycosylated hemoglobin) from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27). Change in fasting glucose concentrations from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27) Change in body weight from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27) Change in seven-point glucose concentrations from Baseline to Week 14 and Week 15
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
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
Additional Information
Starting date: February 2005
Last updated: February 23, 2015
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