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Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin

NCT00082381 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 551

Last updated 2015-04-07

Study results available
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Summary

This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Exenatide (AC2993)

subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks

DRUG

Insulin glargine

subcutaneous injection, once daily; forced titration to target blood glucose level

Sponsors & Collaborators

Principal Investigators

  • Chief Medical Officer, MD · Eli Lilly and Company

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
2003-06-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Finland
  • Germany
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Puerto Rico
  • Spain
  • Sweden

Study Locations

More Related Trials

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 NCT00082381 on ClinicalTrials.gov