NCT00359879CompletedPhase 3
Safety and Efficacy of Exenatide Taken Before Lunch and Before Dinner Compared With Before Breakfast and Before Dinner in Patients With Type 2 Diabetes Using Oral Antidiabetic Therapy
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 377
- Locations
- 1
- Primary Endpoint
- Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12
Study Overview
Brief Summary
This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with type 2 diabetes.
- •Have been treated with one of the following treatment regimens for at least three months prior to screening: *metformin alone; *sulfonylurea (SU) alone; *thiazolidinedione (TZD) alone; *a combination of metformin and SU; *a combination of metformin and TZD.
- •HbA1c between 7.1% and 10.0%, inclusive.
- •Body Mass Index (BMI) > 25 kg/m^2 and < 45 kg/m^2
Exclusion Criteria
- •Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening.
- •Have characteristics contraindicating metformin, SU, or TZD use.
- •Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
- •Have used any prescription drug to promote weight loss within 3 months prior to screening.
- •Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: *insulin within 3 months prior to screening; *alpha-glucosidase inhibitors within 3 months prior to screening; *meglitinides within 3 months prior to screening; *drugs that directly affect gastrointestinal motility
Arms & Interventions
1 - exenatide before breakfast and dinner
Experimental
Intervention: exenatide (Drug)
2 - exenatide before lunch and dinner
Active Comparator
Intervention: exenatide (Drug)
Outcomes
Primary Outcomes
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12
Time Frame: Baseline, Week 12
Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12
Secondary Outcomes
- Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12(Baseline, Weeks 4, 8, 12)
- Change in body weight from Baseline to Week 12, and if measured, at each visit(Baseline, Weeks 4, 8, 12)
- Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit(Baseline, Weeks 4, 8, 12)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 DiabetesType 2 Diabetes MellitusNCT00516074AstraZeneca54
Completed
Phase 4
A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT00477581AstraZeneca102
Completed
Phase 1
A Study to Examine the Pharmacokinetics, Tolerability, Safety and Efficacy of Exenatide Once Weekly SuspensionType 2 Diabetes MellitusNCT00894322AstraZeneca65
Completed
Phase 3
Safety and Efficacy of Exenatide as MonotherapyType 2 Diabetes MellitusNCT00381342AstraZeneca233
Completed
Phase 2
Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT00085969AstraZeneca99