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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: placebo; Drug: Exenatide LAR	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	45 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (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
Study Start Date :	February 2005
Actual Primary Completion Date :	October 2005
Actual Study Completion Date :	October 2005

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

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 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 :

1. 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 ]
2. 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.
3. 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
4. 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
5. 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])

Eligibility Criteria

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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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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	February 18, 2005
Last Update Posted:	February 24, 2015
Last Verified:	January 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