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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00399724
• Collaborator: (none)
• Enrollment: 7,376
• Duration (Months): 17

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Insulin glargine	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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.
• Study Start Date: Mar 1, 2002
• Actual Primary Completion Date: Aug 1, 2003
• Actual Study Completion Date: Aug 1, 2003

Outcome Measures

Primary Outcome Measures

1. Incidence of severe hypoglycaemia []

Secondary Outcome Measures

1. Incidence of any hypoglycaemia []

2. Incidence of symptomatic hypoglycaemia []

3. Incidence of nocturnal hypoglycaemia []

4. Incidence of asymptomatic hypoglycaemia []

5. Adjusted mean change in Hb1Ac (%) []

6. Adjusted mean change in fasting blood glucose (FBG) (mg/dl) []

7. Adjusted mean change in nocturnal blood glucose (NBG) (mg/dl) []

8. Adjusted mean change in mean daily blood glucose (MBG) (mg/dl) []

9. % of subjects at v12 with Hb1Ac < or = 6.5 % []

10. % of subjects at v12 with Hb1Ac < or = 7.0 % []

11. % of subjects at v12 with FBG < or = 100 mg/dl []

12. Weight change (kg) []

13. Change in insulin glargine dose v2 - v12 (IU) []

14. Safety data []

15. Quality of Life and treatment satisfaction before, during and at the end of treatment using the Diabetes Treatment Satisfaction Questionnaire []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Patrick Sinnassamy, MD, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00399724
• Other Study ID Numbers: HOE901_3504
• First Posted: Nov 15, 2006
• Last Update Posted: Aug 31, 2010
• Last Verified: Aug 1, 2010

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Glargine

Study Results

No Results Posted as of Aug 31, 2010