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

NCT01104701 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2015-08-20

Study results available
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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

Interventions

DRUG

exenatide once weekly

subcutaneous injection, 2 mg, once a week

DRUG

exenatide once monthly suspension

subcutaneous injection, low dose, once a month

DRUG

exenatide once monthly suspension

subcutaneous injection, medium dose, once a month

DRUG

exenatide once monthly suspension

subcutaneous injection, high dose, once a month

Sponsors & Collaborators

Principal Investigators

  • Vice President Research and Development · Amylin Pharmaceuticals, LLC.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01104701 on ClinicalTrials.gov