Diabetes Mellitus, Type 2
Conditions
Brief summary
* The primary objective of the present study is to verify the superiority of Telecare program vs. standard SMBG program in terms of mean HbA1c value (- 0,5%) at end-point. * The secondary objectives of the study are the assessment of: total daily dose of insulin, changes in glycaemic and lipid profile, frequency of hypoglycaemias, changes in weight, health-related quality of life, cost-effectiveness of Telecare program vs. common ambulatory program; general safety (adverse event profile, other routine laboratory parameters).
Interventions
DRUGInsulin glulisine
individualized, once daily, dose aiming at 2h post-prandial plasma glucose goal \< 140 mg/dl (7.8 mmol/l) in the optimized treatment phase, since visit 3, subcutaneous
DRUGInsulin glargine
individualized, once daily, dose to reach mean fasting plasma glucose (FPG) \<= 126 mg/dl (7.0 mmol/l), since randomization, subcutaneous
DRUGMetformin
1000 mg b.i.d, since the qualification phase, oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 2 Diabetes Mellitus * Patients treated with combined oral antidiabetic drugs(as fixed combination or simultaneous administration) or with metformin in monotherapy at maximal doses for at least 3 months * Patients having BMI \> 25 Kg/m2; * Patients having a HbA1c ≥ 7.5 % and ≤ 11 % * Female patients must be menopausal, surgically sterile, or using effective contraceptive measures; * Female of childbearing potential must use effective contraceptive measures for at least 1 month prior to the entry into the study and should continue to use the same contraceptive method during the overall study period.
Exclusion criteria
* Patients diagnosed with type 1 insulin dependent Diabetes Mellitus; * History of two or more severe hypoglycaemic episodes within the past 3 months or history of unawareness hypoglycaemia; * Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation); * Impaired renal function * Impaired liver function * History of hypersensitivity to insulin or insulin analogues or any of the excipients in the Insulin glulisine and Insulin glargine formulation * History of hypersensitivity to metformin; * Pregnant or breast-feeding women, or women planning to become pregnant during the study; * Failure to use adequate contraception (women of current reproductive potential only); * Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases or infective diseases; * History of drug or alcohol abuse within the last 2 years or current addiction to substances of abuse; * Night shift workers; * Receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry; * Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study; * Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol; * Any disease or condition including abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator or sponsor may interfere with the completion of the study; * Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study procedures; * Subject is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol; * Previous enrolment in the present study. 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 |
|---|---|
| Changes of glycosilated haemoglobin (HbA1c) | At least 12 weeks from baseline (visit 3) |
Secondary
| Measure | Time frame |
|---|---|
| Changes in plasma insulin levels | At each visit |
| Change of Self-monitoring of Blood Glucose (SMBG) | for the total study duration |
| Mean Amplitude Glucose Excursion (MAGE) | for the total study duration |
| Change in lipid profile | V1 (screening) and V5 (end of treatment) |
| Changes in fasting plasma glucose | At each visit |
| Total daily dose of insulins (glargine and glulisine) | At each visit (starting from V2 for glargine and from V3 for glulisine) |
| Health related Quality of Life | V2 (start of titration), V4 (after 12 weeks of treatment), V5 (end of treatment) |
| Hypoglycemic episodes | for the total study duration |
| Body weight - Body Mass Index | V1 (screening), V3 (start of titration), V4 (after 12 weeks of treatment), V5 (end of treatment), V6 (end of follow-up) |
Countries
Italy
Outcome results
None listed