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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00103935
• Other study ID #: 2993LAR-104
• Status: Completed
• Phase: Phase 2
• First received: February 17, 2005
• Last updated: February 23, 2015
• Start date: February 2005
• Est. completion date: October 2005

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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
Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 2.0 mcg
• 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.
• 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.

Locations

Country	Name	City	State
United States	Research Site	Butte	Montana
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Olympia	Washington
United States	Research Site	Portland	Oregon
United States	Research Site	San Antonio	Texas
United States	Research Site	St. Louis	Missouri
United States	Research Site	Walnut Creek	California

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 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.	Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27	No
Secondary	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 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	Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27	No
Secondary	Change in body weight from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 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	Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27	No
Secondary	Change in seven-point glucose concentrations from Baseline to 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])	Baseline, 3 days between Day -7 and Day -3, and 3 days between Week 14 and Week 15	No