Status:
COMPLETED
Lantus Versus Levemir Treat-To-Target
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief Summary
Primary objective: To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c \< 7% at the end of the trea...
Eligibility Criteria
Inclusion
- Type 2 diabetes for at least 1 year
- Insulin naïve
- Treated with stable doses of oral antidiabetics for at least 3 months prior to study start, including at least metformin (at least 1g/day)
- 7% ≤ HbA1c ≤ 10.5 %
- Body mass index (BMI) \< 40 kg/m²
- Ability and willingness to perform blood glucose monitoring using a blood glucose meter and to use a patient diary
Exclusion
- Type 1 diabetes
- Current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for less than 1 week)
- Treatment with glucagon-like peptide (GLP)-1 receptor agonists or with dipeptidyl peptidase (DPP)-IV inhibitors
- Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
- Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
- Breast-feeding
- History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
- Treatment with systemic corticosteroids in the 3 months prior to study entry
- Treatment with any investigational product in the 2 months prior to study entry
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
- Impaired hepatic function as shown by Alamine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range at study entry
- Impaired renal function as shown by serum creatinine ≥ 1.5 mg/dL (≥ 133 μmol/L) in men and ≥ 1.4 mg/dL (124 μmol/L) in women at study entry
- History of drug or alcohol abuse in the last year
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
973 Patients enrolled
Trial Details
Trial ID
NCT00405418
Start Date
November 1 2006
Last Update
September 15 2009
Active Locations (20)
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1
Sanofi-Aventis
North Ryde, Australia
2
Sanofi-Aventis
São Paulo, Brazil
3
Sanofi-Aventis
Laval, Canada
4
Sanofi-Aventis
Hoersholm, Denmark