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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00103935
First received: February 17, 2005
Last updated: February 5, 2013
Last verified: February 2013
History of Changes

February 17, 2005
February 5, 2013
February 2005
Not Provided
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 ]
Not Provided
Complete list of historical versions of study NCT00103935 on ClinicalTrials.gov Archive Site
  • 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])
Not Provided
Not Provided
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Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • 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
  • 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
  • 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
  • Placebo Comparator: Group A1
    Placebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR
    Intervention: Drug: placebo
  • Placebo Comparator: Group A2
    Placebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR
    Intervention: Drug: placebo
  • Experimental: Group B
    Exenatide lead-in followed by exenatide LAR 0.8 mg weekly
    Intervention: Drug: Exenatide LAR
  • Experimental: Group C
    Exenatide lead-in followed by exenatide LAR 2.0 mg weekly
    Intervention: Drug: Exenatide LAR
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 1;50(1):65-74.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
October 2005
Not Provided

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00103935
2993LAR-104
No
Amylin Pharmaceuticals, LLC.
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
Amylin Pharmaceuticals, LLC.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP