Status:
COMPLETED
Evaluation of the Effectiveness and Safety of Physician Versus Patient-led of Insulin Glargine Initiation and Titration in Type 2 Diabetes Mellitus
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief Summary
Primary Objective: To compare patient-led titration (intervention group) versus physician-led titration (usual standard of care) in optimizing the clinical use of insulin glargine in an Asian populat...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosed with T2DM duration of T2DM \> 2 years
- Insulin naïve
- Continuous treatment with stable doses of 2 OADs (sulphonylureas, biguanides, alpha-glucosidase inhibitors, DPP-IV inhibitors, and glinides) for \> three months prior to randomization
- HbA1c levels 7% and 11 %
- Body mass index (BMI) 20 and 40 kg/m2
- Willing and able to perform blood glucose monitoring using a blood glucose meter
- Exclusion criteria:
- Diabetes other than type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agent intake),
- Current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for \< 1 week),
- Current treatment with thiazolidinediones,
- Current or previous use (within the last 3 months) of GLP-1 receptor agonists or GLP-1 analogues,
- Current or previous (within the last 3 months) use of any treatment for weight lost,
- Active proliferative diabetic retinopathy,
- Patient without any history of eye examination in the past 6 months,
- Treatment with systemic corticosteroids in the 3 months prior to study entry,
- Currently receiving treatment with monoamine oxidase inhibitors,
- Currently receiving treatment with non-selective -blockers,
- Treatment with any investigational product and/or device in the 2 months prior to study entry,
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical trial protocol,
- History of ketoacidosis or hyperosmolar hyperglycemic state,
- History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the previous 12 months,
- History of congestive heart failure,
- History of hypoglycemia unawareness,
- Unexplained hypoglycemia in the past 6 months,
- Impaired renal function defined as, but not limited to, serum creatinine 1.5 mg/dL (133 mol/L) males or 1.4 mg/dL (124 mol/L) females or presence of macroproteinuria (\>2gr/day),
- Active liver disease (alanine transaminase ALAT greater than two times the upper limit of the reference range, as defined by the local laboratory),
- Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol,
- Had a blood transfusion or severe blood loss within the 3 months before screening, or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia,
- Known hypersensitivity / intolerance to insulin glargine or any of its excipients,
- History of pancreatitis,
- Currently undergoing therapy or planned radiological examinations requiring the administration of contrasting agents for malignancy (other than non-metastatic / early stage basal cell or squamous cell carcinoma),
- Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
- Any medical condition that may have an influence on HbA1c rate.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
555 Patients enrolled
Trial Details
Trial ID
NCT01169818
Start Date
August 1 2010
End Date
June 1 2012
Last Update
July 8 2013
Active Locations (6)
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1
Administrative office
Shanghai, China
2
Administrative office
Mumbai, India
3
Administrative office
Tokyo, Japan
4
Administrative office
Karachi, Pakistan