The determination of the exact time of administration of Lantus basal insulin for treating type 2 diabetes mellitus patients poorly controlled with basal insulin associated with oral antidiabetic drugs
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- EUCTR2005-002958-21-HU
- Lead Sponsor
- Sanofi-Synthelabo Rt.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Age between 40 and 65 years
Both gender
Type 2 diabetes mellitus
Combined oral antidiabetic treatment (biguanid + sulfanylurea)
BMI>25 kg/m2, <30 kg/m2
HbA1c>7.0% - <9.0% within one month
Signed Informed consent
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Type 1 diabetes mellitus
known malignancy
drug or alcohol abuse
severe liver disease
renal faliure (se kreatinin> 150 micromol/l)
pregnancy, planned pregnancy, brest feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The determination of the exact time of administration of Lantus basal insulin.;Secondary Objective: ;Primary end point(s): The primary endpoints are the level of HbA1c by the end of both period
- Secondary Outcome Measures
Name Time Method