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Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)

2014-08-27 03:31:35 | BioPortfolio

Summary

Primary objective:

- Efficacy assessment of the percentage of positive responders patients receiving Lantus plus glucophage association. Positive responders patients are defined by a final value of HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).

Secondary objectives:

- Determination of the predictive criterion of HbA1c final,

- Determination of the predictive criterion of weight variation,

- Description of the glycemic and therapeutic criteria in the both groups of responders (positive and negative responders),

- Assessment of the lipidic parameters according to the HbA1c and weight changes during the study (final value - basal value).

Safety:

- Adverse Event (AE)/Serious Adverse Event (SAE) assessments

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Type 2 Diabetes

Intervention

Lantus (insulin glargine) + Glucophage (Metformin)

Location

Sanofi-aventis administrative office
Paris
France

Status

Completed

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:31:35-0400

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Medical and Biotech [MESH] Definitions

A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)

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A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

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The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

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