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Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin

NCT00082407 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 505

Last updated 2015-04-07

Study results available
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Summary

This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

exenatide

subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks

DRUG

biphasic insulin aspart

subcutaneous injection, twice daily; 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
2003-11-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Croatia
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Portugal
  • Romania
  • Russia
  • Slovenia
  • Spain
  • Taiwan
  • United Kingdom

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 NCT00082407 on ClinicalTrials.gov