Insulin Glargine in Type 1 Diabetes Mellitus

NCT00272090 | Completed Phase 3

• 1 other identifier: HOE901_3507
• Study Type: interventional
• Target: 489
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of the protocol is to demonstrate that the new regimen (insulin glargine+regular insulin ) is no worse than the reference regimen (insulin glargine+lys-pro insulin ) in reducing the incidence of severe nocturnal hypoglycemia at the end point; the secondary purpose is to compare the two study regimens as far as the glycemic control (measured by HbA1c), the daily Mean Blood Glucose (MBG) and the mean amplitude of glycemic excursion (MAGE index), calculated on the basis of Self Monitoring Blood Glugose (SMBG) data, are concerned and to verify the safety of basal insulinization with Lantus.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• severe nocturnal hypoglycemias will be measured throughout the study period.

Secondary Outcomes (3)

• HbA1c will be measured at basal and 8/16 weeks after start of treatment

• 8 point glucose profile will be measured during last 2 weeks before each scheduled visit

• severe hypoglycemias and nocturnal hypoglycemias will be measured throughout the study period.

Interventions

Insulin glargine DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects with type 1 diabetes mellitus for more than three years
• Subjects on multiple daily injection insulin therapy, basal-bolus scheme therapy
• HbA1c \<= 9 % (measured by central Lab, with DCCT aligned standard method)
• Fasting C-Peptide \<= 0,1nmol/L with FBG \>126 mg/dl
• Body Mass Index (BMI) \< 30 kg/m2
• Willingness to accept intensive insulin therapy
• Ability and willingness to perform SMBG using plasma glucose meter
• Female subjects must be postmenopausal or under adequate contraception as judged by the investigator (it may be oral contraceptives, intra-uterine device or surgical treatment) and must have a negative serum pregnancy test

You may not qualify if:

• Diabetes other than type 1 diabetic mellitus
• Type 1 diabetic patients with total insulin dose \>= 1 IU/kg/day
• Serum creatinine \> 1.5 mg/dl, or history of renal transplantation or current renal dialysis
• Congestive heart failure NYHA class II
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis
• Clinical evidence of active liver disease, or serum ALT/AST 2 times the upper limit of the normal range
• Hypoglycemia unawareness
• Pregnancy or lactation
• Concomitant use of β-blockers, thiazides or systemic corticosteroids
• More than one episode of severe hypoglycemia with seizure or coma during the past year
• Likelihood of requiring treatment during the study period with any anti-diabetic drug other than the study drugs
• Failure to use adequate contraception (women of current reproductive potential only)
• Known hypersensitivity to insulin glargine, or any of the excipients
• Malignancy except basal cell carcinoma within the last five years
• Long lasting (\> 2 weeks) treatment with systemic glucocorticoid therapy

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

• PAIZIS GEORGES, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 2, 2006
• First Posted: January 4, 2006
• Study Start: November 1, 2002
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: June 8, 2011

Record last verified: 2011-06