Insulin Glargine in Type 1 Diabetes Mellitus

Sanofi

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: Insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00272090

HOE901_3507

Details and patient eligibility

About

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.

Enrollment

489 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Known adrenal insufficiency (interferes with hypoglycemia counter-regulation)
Known hemoglobinopathy or chronic anemia because it may interfere with Hb1Ac determination
History of substance or alcohol abuse within the last two years or current addiction to substances of abuse including ethanol
History of positive HIV test or Hepatitis B/C test
Any usage outside of the current SPC (Summary of the Product Characteristics)
Any clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease other than type 1 diabetic mellitus making implementation of the protocol or interpretation of the study results difficult
History of demonstrable micro- and macro-angiopathic complications
Pre-planned surgery during the study
Blood donation of more than 500 ml during the previous 3 months for males or 6 months for females
Smoker for previous 3 months
Receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry.