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

Diabetes Mellitus, Type 2 Clinical Trial

— AT-LANTUS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399724
• Other study ID #: HOE901_3504
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2006
• Last updated: August 30, 2010
• Start date: March 2002
• Est. completion date: August 2003

Study information

• Verified date: August 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7376
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin glargine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

References & Publications (3)

Davies M, Lavalle-González 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 — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe hypoglycaemia
Secondary	Incidence of any hypoglycaemia
Secondary	Incidence of symptomatic hypoglycaemia
Secondary	Incidence of nocturnal hypoglycaemia
Secondary	Incidence of asymptomatic hypoglycaemia
Secondary	Adjusted mean change in Hb1Ac (%)
Secondary	Adjusted mean change in fasting blood glucose (FBG) (mg/dl)
Secondary	Adjusted mean change in nocturnal blood glucose (NBG) (mg/dl)
Secondary	Adjusted mean change in mean daily blood glucose (MBG) (mg/dl)
Secondary	% of subjects at v12 with Hb1Ac < or = 6.5 %
Secondary	% of subjects at v12 with Hb1Ac < or = 7.0 %
Secondary	% of subjects at v12 with FBG < or = 100 mg/dl
Secondary	Weight change (kg)
Secondary	Change in insulin glargine dose v2 - v12 (IU)
Secondary	Safety data
Secondary	Quality of Life and treatment satisfaction before, during and at the end of treatment using the Diabetes Treatment Satisfaction Questionnaire