A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus (AT-LANTUS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00399724|
Recruitment Status : Completed
First Posted : November 15, 2006
Last Update Posted : August 31, 2010
- To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia.
- 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)
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Insulin glargine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7376 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2002|
|Primary Completion Date :||August 2003|
|Study Completion Date :||August 2003|
- Incidence of severe hypoglycaemia
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399724
|Study Director:||Patrick Sinnassamy, MD||Sanofi|