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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

placebo

Exenatide LAR

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, exenatide, long acting release, Amylin, Lilly

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Research Site
Research Site
Research Site
Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Group A1

Group A2

Group B

Group C

Arm Description

Placebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR

Placebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR

Exenatide lead-in followed by exenatide LAR 0.8 mg weekly

Exenatide lead-in followed by exenatide LAR 2.0 mg weekly

Outcomes

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)

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

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.

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

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

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])

Full Information

NCT ID

NCT00103935

First Posted

February 17, 2005

Last Updated

February 23, 2015

Sponsor

AstraZeneca

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00103935

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

October 2005 (Actual)

Study Completion Date

October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

diabetes, exenatide, long acting release, Amylin, Lilly

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A1

Arm Type

Placebo Comparator

Arm Description

Placebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR

Arm Title

Group A2

Arm Type

Placebo Comparator

Arm Description

Placebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR

Arm Title

Group B

Arm Type

Experimental

Arm Description

Exenatide lead-in followed by exenatide LAR 0.8 mg weekly

Arm Title

Group C

Arm Type

Experimental

Arm Description

Exenatide lead-in followed by exenatide LAR 2.0 mg weekly

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Exenatide LAR

Other Intervention Name(s)

Bydureon

Intervention Description

Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg.

Intervention Type

Drug

Intervention Name(s)

Exenatide LAR

Other Intervention Name(s)

Bydureon

Intervention Description

Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 2.0 mcg.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Title

Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27).

Description

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.

Time Frame

Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27

Title

Change in fasting glucose concentrations from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27)

Description

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

Time Frame

Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27

Title

Change in body weight from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27)

Description

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

Time Frame

Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27

Title

Change in seven-point glucose concentrations from Baseline to Week 14 and Week 15

Description

Time Frame

Baseline, 3 days between Day -7 and Day -3, and 3 days between Week 14 and Week 15

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa Porter, MD

Organizational Affiliation

Amylin Pharmaceuticals, LLC.

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Walnut Creek

State/Province

California

Country

United States

Facility Name

Research Site

City

Honolulu

State/Province

Hawaii

Country

United States

Facility Name

Research Site

City

St. Louis

State/Province

Missouri

Country

United States

Facility Name

Research Site

City

Butte

State/Province

Montana

Country

United States

Facility Name

Research Site

City

Portland

State/Province

Oregon

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

Research Site

City

Olympia

State/Province

Washington

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21142268

Citation

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.

Results Reference

derived

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

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