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A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus

NCT00399724 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7376

Last updated 2010-08-31

No results posted yet for this study

Summary

Primary objective:

* To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia.

Secondary objectives:

* To determine for each treatment algorithm the incidence of asymptomatic, symptomatic and nocturnal hypoglycaemia.
* To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between the treatment algorithms.
* To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment.
* To obtain safety data on the use of insulin glargine in each treatment algorithm.
* To measure change in subject weight and insulin dose between baseline and end of treatment.
* To determine subject quality of life and treatment satisfaction (sub-study)

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin glargine

Sponsors & Collaborators

Principal Investigators

  • Patrick Sinnassamy, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2003-08-31
Completion
2003-08-31

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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 NCT00399724 on ClinicalTrials.gov