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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Insulin glargine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Patrick Sinnassamy, MD, Study Director, Affiliation: Sanofi


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


- To determine subject quality of life and treatment satisfaction (sub-study)

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of severe hypoglycaemia

Secondary outcome:

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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/mĀ².

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations and Contacts

Additional Information

Starting date: March 2002
Last updated: August 30, 2010

Page last updated: August 23, 2015

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