A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus
NCT ID: NCT00399724
Last Updated: 2010-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
7376 participants
INTERVENTIONAL
2002-03-31
2003-08-31
Brief Summary
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* 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)
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Insulin glargine
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Patrick Sinnassamy, MD
Role: STUDY_DIRECTOR
Sanofi
References
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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.
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.
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.
Other Identifiers
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HOE901_3504
Identifier Type: -
Identifier Source: org_study_id