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.

Sanofi0 sites7,376 target enrollmentMarch 2002

Overview

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)

Registry

clinicaltrials.gov

Start Date

March 2002

End Date

August 2003

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Incidence of severe hypoglycaemia

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