Status:
COMPLETED
Insulin Glargine in Type 2 Diabetes Mellitus
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
45+ years
Phase:
PHASE4
Brief Summary
Primary objective: To evaluate in explorative manner the fasting blood glucose (FBG) coefficient of variability (CV)calculated on SMBG values (SMBG : Self-Monitoring of Blood Glucose). Secondary obj...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosis of type 2 diabetes mellitus for at least 5 years;
- Treatment with oral antidiabetic drugs in fixed combination (Combo, i.e. glibenclamide 2.5 mg + metformin 400 mg, 2 or 3 tablets, at stable dose in the last 3 months);
- HbA1c \>= 8% and \<= 11%;
- Body mass index (BMI) \> 27 and \< 35 kg/m2;
- Willingness and demonstrated ability to inject insulin;
- Demonstrated ability and willingness to perform self-monitoring of blood glucose (SMBG);
- Exclusion criteria:
- Patients diagnosed with type 1 insulin dependent diabetes;
- Patients with latent autoimmune diabetes of adults (LADA), defined as fasting C-peptide levels \< 1 ng/ml;
- Cardiac status NYHA III-IV;
- Impaired renal function as shown by (but not limited to) serum creatinine \>= 1.5 mg/dl for males or \>= 1.4 mg/dl for females;
- Planned pregnancy, pregnant or lactating females;
- Failure to use adequate contraception (women of current reproductive potential only);
- Any current malignancy, previous breast cancer, or malignant melanoma within the past 5 years;
- Diagnosis of dementia
- Hypersensitivity to insulin or any of their components or to metformin;
- Current or previous insulin therapy other than during hospitalisations;
- Inability or unwillingness to continue metformin at study dosages throughout the study;
- Treatment with intermittent doses of systemic steroids or large doses of inhaled steroids for the past one year (fixed doses for the past 6 months is acceptable providing there is no plan to change the dosage regime);
- Stroke, Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), Percutaneous Transluminal Coronary Angioplasty (PTCA), or Angina Pectoris within the last 12 months;
- History of drug or alcohol abuse;
- 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 :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00272077
Start Date
April 1 2005
Last Update
December 7 2009
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.