Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes - Full Text View

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 Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Diabetes Type 2

Drug Information available for: Exenatide

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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):

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.


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
Health Authority:	United States: Food and Drug Administration

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 September 23, 2016