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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00399724
• Lead Sponsor: Sanofi

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2006-11-14
• Study First Submitted QC: 2006-11-14
• Study First Posted: 2006-11-15
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-30
• Last Update Posted: 2010-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7376

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of severe hypoglycaemia

Secondary Outcome Measures

Name	Time	Method
Incidence of any hypoglycaemia
Incidence of nocturnal hypoglycaemia
Incidence of asymptomatic hypoglycaemia
Adjusted mean change in Hb1Ac (%)
Adjusted mean change in fasting blood glucose (FBG) (mg/dl)
Adjusted mean change in nocturnal blood glucose (NBG) (mg/dl)
Incidence of symptomatic hypoglycaemia
Adjusted mean change in mean daily blood glucose (MBG) (mg/dl)
% of subjects at v12 with Hb1Ac < or = 6.5 %
% of subjects at v12 with Hb1Ac < or = 7.0 %
% of subjects at v12 with FBG < or = 100 mg/dl
Weight change (kg)
Change in insulin glargine dose v2 - v12 (IU)
Safety data
Quality of Life and treatment satisfaction before, during and at the end of treatment using the Diabetes Treatment Satisfaction Questionnaire