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

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)

Timeline

Start

2002-03

Primary completion

2003-08

Completion

2003-08

Publications

• Results 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.
• Results 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.
• Results 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.
• 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.

Drugs

Indications