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CompletedNCT00399724AT-LANTUSUpdated Aug 31, 2010

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

A Phase 4 interventional study of Insulin glargine in Diabetes Mellitus, Type 2, sponsored by Sanofi. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-08-31.

Sponsored by Sanofi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
7,376
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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)
02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 7,376 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
7,376 participants

Interventions

  • DrugInsulin glargine
06

What researchers measure

Primary outcomes

  1. Incidence of severe hypoglycaemia

Secondary outcomes

  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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 18355327 ↗
  • 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. PubMed 17980928 ↗
  • 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. PubMed 15920040 ↗
  • 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. PubMed 20590745 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00399724
Lead sponsor
Sanofi
First posted
Nov 15, 2006
Start date
Mar 2002
Primary completion
Aug 2003
Completion
Aug 2003
Last update
Aug 31, 2010

Study contacts

Patrick Sinnassamy, MD
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

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