Monitoring the efficacy and safety of lantus in t2 patients failing glycemic control with premix or NPH with OAD or short acting insuli
Phase 4
- Conditions
- type 2 diabetes.
- Registration Number
- IRCT2012110411356N1
- Lead Sponsor
- Sanofi Aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 230
Inclusion Criteria
suffering from diabetes Mellitus type 2; agebetween 19 to 79 years ; patients who previously failed to achieve a glycemic control (HbA1c = 7 %; ADA, EASD.) under premixesi nsulin BD or NPH with OAD or short acting insulins and patients must sign the informed consent.
Exclusion criteria: patients with severe renal failure and haemodialysis; patients with sever hepatic failure, pregnancy or breast feeding; mental disorders; hypersensitivity to basal insulin and inability to perform SMBG.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c level each visit. Timepoint: 24 weeks. Method of measurement: choromotography.
- Secondary Outcome Measures
Name Time Method Proportion of patients reaching the glycemic control. Timepoint: 24 weeks. Method of measurement: choromatography.