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

Browse trials for

• Diabetes Mellitus 10,923
• Diabetes Mellitus, Type 2 9,357

Keywords

• diabetes
• exenatide
• long acting release
• Amylin
• Lilly

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 45 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Study arms

• Placebo comparator
  Group A1

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

  Drug: placebo

• Placebo comparator
  Group A2

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

  Drug: placebo

• Experimental
  Group B

  Exenatide lead-in followed by exenatide LAR 0.8 mg weekly

  Drug: Exenatide LAR

• Experimental
  Group C

  Exenatide lead-in followed by exenatide LAR 2.0 mg weekly

  Drug: Exenatide LAR

Interventions

• Drugplacebo

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

• Drugplacebo

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

• DrugExenatide LAR

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

  Also known as: Bydureon

• DrugExenatide LAR

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

  Also known as: Bydureon

Primary outcomes

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 outcomes

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).

   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

3. 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

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

4. 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

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

5. 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 \[Week 15\])

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

Publications

• 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. PubMed 21142268 ↗