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Completed

NCT Number: NCT00399724

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

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)

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Acronym: AT-LANTUS

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Nov 15, 2006
Registry last updated
Aug 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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