NCT01104701CompletedPhase 2
A Randomized, Multi-dose, Controlled Trial Investigating the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population
Study Overview
Brief Summary
The purpose of Study BCB111 is to collect efficacy, pharmacokinetic, pharmacodynamic, safety, and tolerability data in patients with type 2 diabetes to assess the feasibility of once monthly dosing of the exenatide suspension formulation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Is at least 18 years old at study start
- •Has been diagnosed with type 2 diabetes mellitus
- •Has HbA1c of 7.1% to 11.0%, inclusive, at study start
- •Has been treated with diet and exercise alone or with a stable regimen of metformin, pioglitazone, or a combination of metformin and pioglitazone, for a minimum of 2 months prior to study start
- •Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: hormone replacement therapy (female subjects); antihypertensive agents; thyroid replacement therapy; or antidepressant agents
Exclusion Criteria
- •Clinically significant medical condition that could potentially affect study participation including:
- •Acute or chronic pancreatitis
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2
- •Active cardiovascular disease within 3 months of study start
- •Underlying hepatic or renal disease
- •Inflammatory bowel disease, or other severe gastrointestinal diseases (particularly those that may affect gastric emptying, such as gastroparesis, pyloric stenosis, and metabolic surgery)
- •Has had > 2 episodes of major hypoglycemia in the preceding 6 months before study start
- •Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start
- •Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
- •Any exposure to exenatide (BYETTA®, exenatide once weekly, or exenatide suspension), liraglutide (Victoza®), or any GLP-1 receptor agonist
- •Any DPP-IV inhibitor, sulfonylurea (SU), or rosiglitazone (Avandia®) within 3 months prior to study start
- •Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days prior to study start
- •Insulin within 2 weeks prior to study start, or for more than 1 week within 3 months prior to study start
- •Systemic corticosteroids by oral, intravenous, intra-articular, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
- •Prescription or over-the-counter weight loss medications within 3 months prior to study start
Arms & Interventions
Group A
Active Comparator
2 mg exenatide once weekly subcutaneous (SC). This arm is used as a reference arm in the study.
Intervention: exenatide once weekly (Drug)
Group B
Experimental
Low dose 5 mg exenatide once monthly suspension SC.
Intervention: exenatide once monthly suspension (Drug)
Group C
Experimental
Medium dose 8 mg exenatide once monthly suspension SC.
Intervention: exenatide once monthly suspension (Drug)
Group D
Experimental
High dose 11 mg exenatide once monthly suspension SC.
Intervention: exenatide once monthly suspension (Drug)
Outcomes
Primary Outcomes
Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population
Time Frame: Baseline (Day 1) to 20 weeks
HbA1c was measured as a percent of total hemoglobin at screening, Baseline, and during treatment on Weeks 4, 8, 12, 16, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. The Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.
Secondary Outcomes
- Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population(Baseline (Day 1) to Week 20)
- Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population(Baseline (Day 1) to Week 20)
- Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population(Day 1 to Study Termination (24 Weeks) or early Termination)
- Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population(Day 1 to Study Termination (Week24) or early termination)
- Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population(Week 20)
- Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population(Day 1 to Week 20)
- Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population(Day 1 through study termination (Week 24) or early termination.)
- Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population(Baseline (Day 1), Week 20)
- Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population(Baseline (Day 1), Week 20)
- Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population(Day 1 to Study Termination (24 weeks) or early termination)
- Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population(Day 1 to study termination (24 weeks) or early termination)
Investigators
Study Sites (1)
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