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

Study Overview
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Brief Summary
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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)

Official Title
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A Multicentre, Multinational, Randomised, Open Study to Establish the Optimal Method for Initiating and Maintaining Lantus® (Insulin Glargine) Therapy Based on a Comparison of Two Treatment Algorithms to Determine Optimal Metabolic Outcomes, Safety, and Satisfaction in Subjects With Type 2 Diabetes Mellitus.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin glargine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Subjects with Type 2 Diabetes Mellitus, Subjects on antidiabetic treatment (oral and/or insulin therapy) for > 6 months, Subjects who require a basal long-acting insulin for the control of hyperglycaemia, HbA1c values > 7.0% and < 12 %, BMI < 40 kg/m². The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin glargine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe hypoglycaemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of any hypoglycaemia |  |  | 
| Incidence of symptomatic 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) |  |  | 
| 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 |  |  |