A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension

NCT01104701 | Completed Phase 2 Results

• 1 other identifier: BCB111
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes

Keywords

Exenatide; Amylin; Lilly; Byetta; Exenatide Once Weekly

Outcome Measures

Primary Outcomes (1)

• Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population

  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.

  Baseline (Day 1) to 20 weeks

Secondary Outcomes (11)

• Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population

  Week 20

• 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

• 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

• Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population

  Baseline (Day 1), Week 20

Study Arms (4)

Group A

ACTIVE COMPARATOR

2 mg exenatide once weekly subcutaneous (SC). This arm is used as a reference arm in the study.

Drug: exenatide once weekly

Group B

EXPERIMENTAL

Low dose 5 mg exenatide once monthly suspension SC.

Drug: exenatide once monthly suspension

Group C

EXPERIMENTAL

Medium dose 8 mg exenatide once monthly suspension SC.

Drug: exenatide once monthly suspension

Group D

EXPERIMENTAL

High dose 11 mg exenatide once monthly suspension SC.

Drug: exenatide once monthly suspension

Interventions

exenatide once weekly DRUG

subcutaneous injection, 2 mg, once a week

Group A

exenatide once monthly suspension DRUG

subcutaneous injection, low dose, once a month

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Eli Lilly and Company: collaborator

Study Sites (2)

Research Site

Phoenix, Arizona, United States

Location

Research Site

Lincoln, Nebraska, United States

Location

Related Publications (1)

• 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.

  PMID: 27436275 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: AstraZeneca
• Organization: Clinical Trial Transparency

ClinicalTrialTrasparency@astrazeneca.com

Study Officials

• Vice President Research and Development

  Amylin Pharmaceuticals, LLC.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 15, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 20, 2015
• Results First Posted: July 17, 2014

Record last verified: 2015-07

Locations

US (2)