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

This study has been completed.

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00537251

Purpose

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	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: Insulin glargine	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin glargine Insulin lispro Insulin, isophane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
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.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 ]

Enrollment:	80
Study Start Date:	November 2001
Study Completion Date:	February 2004

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)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537251

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Jose Taboada Mosquera

Sanofi-Aventis

More Information

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

Study ID Numbers:	HOE901_4023
Study First Received:	September 28, 2007
Last Updated:	September 28, 2007
ClinicalTrials.gov Identifier:	NCT00537251
Health Authority:	Spain: Comité Ético de Investigación Clínica

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Glargine
Diabetes Mellitus
Insulin LISPRO

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009