MedTrace Logo

Insulin Glargine Injection Treatment in Place of Thiazolidinedione (TZD), Sulfonylurea, or Metformin in Triple Agent Therapy for Type 2 Diabetes Mellitus (T2DM) Adult Subjects With Unsatisfactory Control

NCT00283049 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2011-01-13

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin Glargine

Insulin glargine administered subcutaneously once daily.

DRUG

Insulin Glulisine

Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)

Sponsors & Collaborators

Principal Investigators

  • Lisa Jean-Louis · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States

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 NCT00283049 on ClinicalTrials.gov