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OpenTrials
Completed

NCT Number: NCT00537251

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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)

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

insulin glargine

Drug

Primary outcomes

  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

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Important dates

Study start
2001
Study completion
2004
First posted
Oct 1, 2007
Registry last updated
Oct 1, 2007

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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