Insulin Glargine in Type I Diabetes Mellitus> Main Study "AT.LANTUS": A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar. Sub-study: "HALT"(Hypoglycaemia Avoidance With Lantus Trial)

NCT00390728 | Completed Phase 4

• 1 other identifier: HOE901_3505
• Study Type: interventional
• Target: 2,346
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary objective: AT.LANTUS main study\*

• To determine the optimal treatment algorithm for insulin glargine based on the incidence of severe hypoglycaemia.(\*Target Number of patients for the main study:2346) HALT Sub-study\*\*
• To test the hypothesis that titration regimens involving insulin glargine are associated with changes in the rate of symptomatic hypoglycaemic episodes together with changes in Fear of Hypoglycaemia as measured by the HFS-98 Questionnaire in Type I diabetes.(\*\*Target Number of patients for the Sub-study: 250) Secondary objectives: AT.LANTUS main study To determine:
• the incidence of symptomatic, asymptomatic and nocturnal hypoglycaemia with each treatment regimen
• the difference in glycemic control as measured by HbA1c and fasting blood glucose with each treatment regimen
• the difference in glycemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment
• the safety on the use of insulin glargine in each treatment algorithm
• the change in subject weight with each treatment regimen
• the change in insulin doses with each treatment regimen
• the change in Diabetes Treatment Satisfaction (Diabetes Treatment Satisfaction Questionnaire, sub-study only) with each treatment regimen HALT Sub-study (baseline to study end)
• To estimate the relationship between change in HbA1c and incidence of hypoglycaemia
• To examine the effect of insulin glargine on Quality of Life (EQ-5D) in relation to incidence of hypoglycaemia
• To examine the effect of insulin glargine on the Hospital Anxiety and Depression Scale (HADS) in relation to the incidence of hypoglycaemia
• To examine the use of the Prescription Plan versus standard management (no Prescription Plan)

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

• Main study: Frequency of severe hypoglycaemia

• Sub-study: The fear of hypoglycaemia as measured by the Hypoglycaemia Fear Survey questionnaire (HFS-98) assessed at baseline, 3 months and study end point or upon withdrawal of the subject from the study.

Secondary Outcomes (16)

• Main study: HbA1c

• Incidence of nocturnal, symptomatic and asymptomatic hypoglycaemia

• Self monitored blood glucose

• Change in subject weight

• Changes in doses of insulin

Interventions

Insulin Glargine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with type 1 diabetes mellitus who require a basal (long-acting) insulin for the control of hyperglycemia, with HbA1c values \> 7.0% and \< 12 %, and a body mass index (BMI) \< 40 kg/m2.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Patrick SINNASSAMY, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 20, 2006
• Study Start: April 1, 2002
• Primary Completion: August 1, 2003
• Study Completion: August 1, 2003
• Last Updated: August 31, 2010

Record last verified: 2010-08