Status:
COMPLETED
Comparison Safety and Efficacy of Basal Insulin Lantus® (Insulin Glargine) vs NPH Insulin in Combination With Oral Antidiabetic Drugs (OADs) in Patients With Diabetes Mellitus, Type 2 (DMT2)
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Aim of the study is to compare two treatment regimens (insulin Lantus as basal insulin vs insulin NPH) plus oral antidiabetics in type 2 diabetic patients and confirm superiority of insulin glargine. ...
Eligibility Criteria
Inclusion
- Diabetes type 2
- Patients treated NPH insulin with stable dosage of OADs (Oral antidiabetic drugs) for at least 2 months prior to study start and OADs treatment with metformin at least 1,7 g /day in combination with sulfonylurea or glinides.
- Patients must have a HbA1c range of \>= 4,5% ( 6,2% DCCT/Diabetes Control and Complication Trials) and \<= 8% ( 9,4 % DCCT/Diabetes Control and Complication Trials)
- Ability and willingness to perform continuous glucose monitoring system / CGMS (examination within the study)
- Written informed consent obtained prior to enrollment in the study
- Women are either not of childbearing potential or women of childbearing potential must not be pregnant and must use a reliable contraceptive measure for the duration of the study
Exclusion
- Fasting value C peptide \<= 400 pmol/l
- 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.
- Pregnant women or women planning gravidity during clinical study protocol
- 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 and during study and other treatment, that can significantly have impression to glycaemia.
- 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 \>/= 133 micromol/L in men and \>/= 124 micromol/L in women at study entry
- History of drug or alcohol abuse in the last year
- Mental condition causing the patient unable to understand the nature, scope and possible consequences of the study
- Patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
- Use of insulin glargine outside the scope of the current SPC (Summary of Product Characteristics)
- 16\. Patients included in other clinical studies
- 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 :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00659477
Start Date
March 1 2008
End Date
June 1 2009
Last Update
July 30 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Prague, Czechia