Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, exenatide, long acting release, Amylin, Lilly
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.
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
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.
Sponsors
Eli Lilly and Company
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27). | 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. |
| Change in fasting glucose concentrations from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27) | 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 |
| Change in body weight from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27) | 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 |
| Change in seven-point glucose concentrations from Baseline to Week 14 and Week 15 | 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 \[Week 15\]) |
Countries
United States
Outcome results
None listed