32 Week, Open, Randomized, 2 Way Cross Over Multicentre Trial to Compare Safety & Efficacy of Combination of HOE901 Insulin Analogue Once Daily at Bedtime + Lispro Insulin Before Meals vs NPH Insulin (Twice a Day) + Regular in Type 1 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00537251
Recruitment Status : Completed
First Posted : October 1, 2007
Last Update Posted : October 1, 2007
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Brief Summary:
To compare the efficacy (in terms of metabolic control evaluated through HbA1c levels) of treatment with insulin glargine as basal insulin and insulin analogue (insulin lispro) as mealtime insulin with a regimen of insulin NPH as basal insulin with regular insulin, as mealtime insulin, after a 16 week treatment phase with each regimen and to compare the safety of both treatments, evaluated through hypoglycemic rates.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Insulin glargine Phase 3

Detailed Description:

Multicenter, open-label, randomized (allocation ratio 1:1), cross-over with two treatment phases of 16 weeks each in two treatment groups:

  • Study arm with insulin glargine + insulin lispro (phase 1) and insulin NPH + regular insulin (phase 2)
  • Insulin NPH + regular insulin (phase 1) and insulin glargine + insulin lispro (phase 2)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 32-Week, Open, Randomized, Cross-Over, Local, Multicenter Clinical Trial Comparing Insulin Glargine in Combination With Insulin Analogue (Insulin Lispro) to NPH Insulin in Combination With Regular Insulin in Type 1 Diabetes Mellitus Patients in an Intensified Insulin Regimen.
Study Start Date : November 2001
Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Primary Outcome Measures :
  1. Compare efficacy of insulin glargine & short acting insulin (Lispro), NPH insulin regime as basal insulin and regular insulin for meal insulin for metabolic control, evaluated by means of HbA1c . [ Time Frame: after 16 weeks of treatment with each treatment regime ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with type 1 diabetes mellitus
  • 18-65 years of age
  • C-Peptide negative
  • Treated at least for 6 months with multiple daily doses of insulin and with HbA1c greater than or equal to 7.0% and less than or equal to 9.5% and a BMI less than or equal to 35 kg/m².
  • Women of childbearing potential must have a negative pregnancy test in visit 1 and must use an effective contraceptive method during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00537251

Sponsors and Collaborators
Study Director: Jose Taboada Mosquera Sanofi Identifier: NCT00537251     History of Changes
Other Study ID Numbers: HOE901_4023
First Posted: October 1, 2007    Key Record Dates
Last Update Posted: October 1, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin Glargine
Insulin, Isophane
Isophane Insulin, Human
Hypoglycemic Agents
Physiological Effects of Drugs