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Insulin Glargine "All to Target" Trial

NCT00384085 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 588

Last updated 2011-05-06

Study results available
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Summary

The primary objectives were:

* To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c \[HbA1c\] \<7.0%) at Week 60
* To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from Baseline to Week 60 in HbA1c

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin Glulisine

Subcutaneous injection up to 1 injection per day

DRUG

Insulin Glargine

Subcutaneous injection once-a-day

DRUG

Premixed Insulin

Subcutaneous injection twice-a-day.

DRUG

Insulin Glulisine

Subcutaneous injection up to 3 injections per day.

Sponsors & Collaborators

Principal Investigators

  • Medical Affairs · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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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 NCT00384085 on ClinicalTrials.gov