Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)
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: exenatide, long acting release (Drug); exenatide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Lisa Porter, MD, Study Director, Affiliation: Amylin Pharmaceuticals, LLC.
Summary
This is a Pharmacokinetic (PK) sub-study to determine the relative bioavailability of
exenatide when administered using the once weekly dual chambered pen and the once weekly
single dose tray.
Clinical Details
Official title: A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in HbA1c From Baseline to Week 30Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen -11 Weekly Dose)
Secondary outcome: Percentage of Subjects Achieving HbA1c Target of <7%Percentage of Subjects Achieving HbA1c Target of <=6.5% Percentage of Subjects Achieving HbA1c Target of <=6.0% Change in Body Weight From Baseline to Week 30 Change in Fasting Plasma Glucose From Baseline to Week 30 Change in Blood Pressure From Baseline to Week 30 Change in Total Cholesterol From Baseline to Week 30 Change in High-density Lipoprotein (HDL) From Baseline to Week 30 Ratio of Triglycerides at Week 30 to Baseline Exenatide LAR Steady State Concentration From Week 29 to Week 30 Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14 Sub-study Safety and Tolerability of Exenatide When Administered Using the Once Weekly Single Dose Tray and the Once Weekly Dual (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen -11 Weekly Dose)
Detailed description:
Enrollment #: Original protocol Actual # of subjects: 303, Sub-study planned # of subjects:
130
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Has type 2 diabetes mellitus treated with diet modification and exercise alone or in
combination with a stable regimen of a combination of metformin, sulphonylureas, and
thiazolidinediones for a minimum of 2 months at screening.
- Hemoglobin A1c (HbA1c) of 7. 1% to 11. 0%, inclusive, at screening.
- Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
- (For sub-study) Currently participating in open ended assessment period of main study
2993 LAR105
Exclusion Criteria:
- Has been previously exposed to exenatide (Byetta®), exenatide LAR, or any
glucagon-like peptide-1 (GLP-1) analog.
- Received any investigational drug or has participated in any type of clinical trial
within 30 days prior to screening.
- Has been treated, is currently treated, or is expected to require or undergo
treatment with any of the following excluded medications:
- Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
- Insulin within 2 weeks prior to screening or insulin for longer than 1 week
within 3 months of screening;
- Regular use (> 14 days) of drugs that directly affect gastrointestinal motility;
- Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or
intramuscular route; or potent, inhaled, or intrapulmonary steroids known to
have a high rate of systemic absorption;
- Regular use (> 14 days) of medications with addictive potential such as opiates
and opioids;
- Prescription or over-the-counter weight loss medications within 6 months of
screening.
- (For sub-study) Subjects will be terminated from study who do not participate in the
dual chamber pen substudy
Locations and Contacts
Research Site 182, Encino, California 91436, United States
Research Site 171, La Jolla, California 92037, United States
Research Site 518, San Diego, California 92161, United States
Research Site 024, Walnut Creek, California 94598, United States
Research Site, Colorado Springs, Colorado, United States
Research Site 057, Miami, Florida 33156, United States
Research Site, Chicago, Illinois, United States
Research Site 149, Indianapolis, Indiana 46254, United States
Research Site 099, Lexington, Kentucky 40503, United States
Research Site 017, Detroit, Michigan 48202, United States
Research Site 224, Minneapolis, Minnesota 55416, United States
Research Site 312, St. Louis, Missouri 63141, United States
Research Site 023, Butte, Montana 59701, United States
Research Site 053, Rochester, New York 14609, United States
Research Site 002, Durham, North Carolina 27713, United States
Research Site 123, Winston-Salem, North Carolina 27103, United States
Research Site 405, Cincinnati, Ohio 45219, United States
Research Site 557, Marion, Ohio 43302, United States
Research Site, Toronto, Ontario, Canada
Research Site 231, Portland, Oregon 97239, United States
Research Site 152, Philadelphia, Pennsylvania 19146, United States
Research Site 587, Greer, South Carolina 29651, United States
Research Site 015, Dallas, Texas 75230, United States
Research Site 009, San Antonio, Texas 78229, United States
Research Site 108, Olympia, Washington 98502, United States
Additional Information
Starting date: April 2006
Last updated: February 17, 2015
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