Status:
COMPLETED
Insulin Glargine in Type 1 Diabetes Mellitus
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
489 Patients enrolled
Trial Details
Trial ID
NCT00272090
Start Date
November 1 2002
End Date
December 1 2005
Last Update
June 8 2011
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