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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

HOE901_3504

Details and patient eligibility

About

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)

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.