Phase 2
Completed N=121
A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension
Source: ClinicalTrials.gov NCT01104701 ↗Enrolled (actual)
121
Serious AEs
1.7%
Results posted
Jul 2014
Primary outcomePrimary: Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population — -0.52; -0.33; -0.24; -0.34 Percent of Hemoglobin
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population |
-0.52; -0.33; -0.24; -0.34; -1.15; -0.89 | — |
| SECONDARY Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population |
48.3; 50.0; 57.1; 70.4; 44.8; 26.9 | — |
| SECONDARY Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population |
-0.31; 0.32; 0.31; 0.35; -0.66; -0.04 | — |
| SECONDARY Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population |
-1.16; -12.9; -14.6; -23.5; -21.7; -18.0 | — |
| SECONDARY Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population |
262.92; 127.13; 247.38; 218.07; 171.27; 198.06 | — |
| SECONDARY Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population |
-1.7; 3.4; 1.8; 1.9; -2.3; 4.4 | — |
| SECONDARY Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population |
2.8; 3.9; 5.6; -0.3 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population |
27; 25; 20; 24; 0; 2 | — |
| SECONDARY Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population |
6; 8; 3; 6 | — |
| SECONDARY Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population |
27; 30; 30; 29; 3; 0 | — |
| SECONDARY Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population |
0; 1; 0; 0; 0; 1 | — |
| SECONDARY Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population |
1; 1; 0; 0; 1; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01104701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.