Clinical trial NCT01104701: A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension
Official title: A Randomized, Multi-dose, Controlled Trial Investigating the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: Exenatide
Amylin
Lilly
Byetta
Exenatide Once Weekly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2010-04-15
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population
timeFrame: Baseline (Day 1) to 20 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population
timeFrame: Week 20
measure: Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population
timeFrame: Baseline (Day 1) to Week 20
measure: Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population
timeFrame: Baseline (Day 1) to Week 20
measure: Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population
timeFrame: Day 1 to Week 20
measure: Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population
timeFrame: Baseline (Day 1), Week 20
measure: Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population
timeFrame: Baseline (Day 1), Week 20
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population
timeFrame: Day 1 to Study Termination (24 Weeks) or early Termination
measure: Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population
timeFrame: Day 1 through study termination (Week 24) or early termination.
measure: Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population
timeFrame: Day 1 to Study Termination (24 weeks) or early termination
measure: Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population
timeFrame: Day 1 to study termination (24 weeks) or early termination
measure: Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population
timeFrame: Day 1 to Study Termination (Week24) or early termination
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Lincoln
country: United States
facility: Research Site
state: Nebraska
Study officials:
affiliation: Amylin Pharmaceuticals, LLC.
name: Vice President Research and Development
role: STUDY_DIRECTOR
References:
citation: Wysham CH, MacConell L, Hardy E. Efficacy and Safety of Multiple Doses of Exenatide Once-Monthly Suspension in Patients With Type 2 Diabetes: A Phase II Randomized Clinical Trial. Diabetes Care. 2016 Oct;39(10):1768-76. doi: 10.2337/dc16-0238. Epub 2016 Jul 19.