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Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes

NCT01652716 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 377

Last updated 2018-07-03

Study results available
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Summary

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.

To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Exenatide once weekly suspension

Exenatide suspension 2 mg weekly subcutaneous injection

DRUG

Exenatide twice daily

5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Vice President Medical Research & Development, M.D. · 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
2013-01-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Entities

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 NCT01652716 on ClinicalTrials.gov