Clinical trial NCT00399724: A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-11-15
Enrollment: 7376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility 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.

Primary outcomes:
measure: Incidence of severe hypoglycaemia
Secondary outcomes:
measure: Incidence of any hypoglycaemia
measure: Incidence of symptomatic hypoglycaemia
measure: Incidence of nocturnal hypoglycaemia
measure: Incidence of asymptomatic hypoglycaemia
measure: Adjusted mean change in Hb1Ac (%)
measure: Adjusted mean change in fasting blood glucose (FBG) (mg/dl)
measure: Adjusted mean change in nocturnal blood glucose (NBG) (mg/dl)
measure: Adjusted mean change in mean daily blood glucose (MBG) (mg/dl)
measure: % of subjects at v12 with Hb1Ac < or = 6.5 %
measure: % of subjects at v12 with Hb1Ac < or = 7.0 %
measure: % of subjects at v12 with FBG < or = 100 mg/dl
measure: Weight change (kg)
measure: Change in insulin glargine dose v2 - v12 (IU)
measure: Safety data
measure: Quality of Life and treatment satisfaction before, during and at the end of treatment using the Diabetes Treatment Satisfaction Questionnaire
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Patrick Sinnassamy, MD
role: STUDY_DIRECTOR
References:
citation: Davies M, Lavalle-Gonzalez F, Storms F, Gomis R; AT.LANTUS Study Group. Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial. Diabetes Obes Metab. 2008 May;10(5):387-99. doi: 10.1111/j.1463-1326.2008.00873.x. Epub 2008 Mar 18.
citation: Davies M, Sinnassamy P, Storms F, Gomis R; AT.LANTUS Study Group. Insulin glargine-based therapy improves glycemic control in patients with type 2 diabetes sub-optimally controlled on premixed insulin therapies. Diabetes Res Clin Pract. 2008 Feb;79(2):368-75. doi: 10.1016/j.diabres.2007.09.013. Epub 2007 Nov 5.
citation: Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R; ATLANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care. 2005 Jun;28(6):1282-8. doi: 10.2337/diacare.28.6.1282.
citation: Khunti K, Srinivasan BT, Shutler S, Davies MJ. Effect of insulin glargine on glycaemic control and weight in obese and non-obese people with type 2 diabetes: data from the AT.LANTUS trial. Diabetes Obes Metab. 2010 Aug;12(8):683-8. doi: 10.1111/j.1463-1326.2010.01217.x.