Diabetes Mellitus, Type 2
Conditions
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 population of patients with Type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs (OADs). Secondary Objectives: To determine the difference in glycemic control, safety, quality of life and treatment satisfaction between patient-led titration and usual care.
Interventions
DRUGInsulin Glargine
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: initial: once a day in the evening at bedtime. Titration will occur each time the middle FPG (Fasting Plasma Glucose) value is above target
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with T2DM duration of T2DM \> 2 years 2. Insulin naïve 3. Continuous treatment with stable doses of 2 OADs (sulphonylureas, biguanides, alpha-glucosidase inhibitors, DPP-IV inhibitors, and glinides) for \> three months prior to randomization 4. HbA1c levels 7% and 11 % 5. Body mass index (BMI) 20 and 40 kg/m2 6. Willing and able to perform blood glucose monitoring using a blood glucose meter
Exclusion criteria
1. Diabetes other than type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agent intake), 2. Current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for \< 1 week), 3. Current treatment with thiazolidinediones, 4. Current or previous use (within the last 3 months) of GLP-1 receptor agonists or GLP-1 analogues, 5. Current or previous (within the last 3 months) use of any treatment for weight lost, 6. Active proliferative diabetic retinopathy, 7. Patient without any history of eye examination in the past 6 months, 8. Treatment with systemic corticosteroids in the 3 months prior to study entry, 9. Currently receiving treatment with monoamine oxidase inhibitors, 10. Currently receiving treatment with non-selective -blockers, 11. Treatment with any investigational product and/or device in the 2 months prior to study entry, 12. Likelihood of requiring treatment during the study period with drugs not permitted by the clinical trial protocol, 13. History of ketoacidosis or hyperosmolar hyperglycemic state, 14. History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the previous 12 months, 15. History of congestive heart failure, 16. History of hypoglycemia unawareness, 17. Unexplained hypoglycemia in the past 6 months, 18. 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), 19. Active liver disease (alanine transaminase ALAT greater than two times the upper limit of the reference range, as defined by the local laboratory), 20. Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol, 21. Had a blood transfusion or severe blood loss within the 3 months before screening, or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, 22. Known hypersensitivity / intolerance to insulin glargine or any of its excipients, 23. History of pancreatitis, 24. 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), 25. Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method), 26. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change (decrease) in mean hemoglobin glycosylated (HbA1c) level | from week 0 (baseline) to week 24 (end of study) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving target HbA1c levels (< 7.0% and <6.5%) | from week 0 (baseline) to week 24 (end of study) |
| Number of patients having a drop of 1% in HbA1c levels and/or a drop of at least 0.5%. | from week 0 (baseline) to week 24 (end of study) |
| Mean change in Fasting Plasma glucose (FPG) and Post Prandial blood Glucose (PPG) | from week 0 (baseline) to week 24 (end of study) |
| Evolution of Blood Glucose profiles | from week 0 (baseline) to week 24 (end of study) |
| Incidence of symptomatic hypoglycemia | from week 0 (baseline) to week 24 (end of study) |
| Percentage of patients achieving HbA1c levels < 7.0% without experiencing severe hypoglycemia | from week 0 (baseline) to week 24 (end of study) |
| Incidence of asymptomatic hypoglycemia | from week 0 (baseline) to week 24 (end of study) |
| Mean change in body weight in patients | from week 0 (baseline) to week 24 (end of study) |
| Mean insulin dose | from week 0 (baseline) to week 24 (end of study) |
| PROMs (patient reported outcome measures) scores from the DTSQs/c (diabetes treatment satisfaction questionnaire status) and EQ-5D (European quality of life - 5 dimensions) | from week 0 (baseline) to week 24 (end of study) |
| Incidence of nocturnal hypoglycemia | from week 0 (baseline) to week 24 (end of study) |
Countries
China, India, Japan, Pakistan, Philippines, Russia
Outcome results
None listed