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Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes

NCT00097500 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2015-04-07

Study results available
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Summary

This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.

Conditions

Interventions

DRUG

exenatide

subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets

DRUG

Insulin glargine

subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets

DRUG

Metformin

Patients usual dosage

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Finland
  • Netherlands
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
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 NCT00097500 on ClinicalTrials.gov