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A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes

NCT00960661 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1036

Last updated 2015-04-07

Study results available
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Summary

The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.

Conditions

Interventions

DRUG

exenatide

subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day

DRUG

insulin lispro

titrated based on pre-meal glucose level; three times a day

DRUG

Metformin

DRUG

Insulin/ Glargine

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
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Argentina
  • Belgium
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Mexico
  • Netherlands
  • Portugal
  • Puerto Rico
  • Romania
  • Russia
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

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 NCT00960661 on ClinicalTrials.gov