A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus (AT-LANTUS)
This study has been completed.
Information provided by:
First received: November 14, 2006
Last updated: August 30, 2010
Last verified: August 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)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Incidence of severe hypoglycaemia
Secondary Outcome Measures:
- 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
|Study Start Date:||March 2002|
|Study Completion Date:||August 2003|
|Primary Completion Date:||August 2003 (Final data collection date for primary outcome measure)|
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