Type 2 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: To identify a best fasting plasma glucose (FPG) target for Chinese type 2 diabetes patients using insulin glargine which can provide the highest control rate of glycated hemoglobin (HbA1c) \< 7%. Secondary Objectives: The control rate of HbA1c ≤6.5% achievement. The control rate of HbA1c \<7.0% in patients achieving their FPG target. The percentage of HbA1c \<7% without hypoglycemia. The percentage of patients achieving the FPG target without hypoglycemia. The percentage of patients achieving the FPG target and post prandial glucose (PPG) target (2-hour post breakfast \<10 mmol/L).
Detailed description
The study duration for each patient will be 27 weeks.
Interventions
DRUGINSULIN GLARGINE
Pharmaceutical form: solution Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
: * 18 to 65 years old. * Type 2 diabetes patients insufficient controlled by 1-3 oral anti-hyperglycemic drugs (OADs) with stable dose at least 3 months: * If on 1 OAD, provided with the following doses (including but not limited to): * α-glucosidase inhibitor: 100mg, three times a day (tid); * metformin: 1.5-2.0 g/day; * sulphonylureas: sub-maximum (half dose above) to maximum tolerated dose; * thiazolidinediones: eg. pioglitazone, 30-40 mg/day. * Besides the medications listed above, if on 1 OAD, others should be maximum tolerated dose allowed in package insert. * If on 2-3 OADs, any range of dose is acceptable. * HbA1c \>7%, and ≤10.5%. * FPG \>7 mmol/L. * Body mass index (BMI) ≥20 kg/m\^2, and ≤40 kg/m\^2. * Diabetes duration ≥1 year. * Physician decides to and the patient is willing to start basal insulin (BI) treatment. * Willing to join the study and sign the informed consent.
Exclusion criteria
* Type 1 diabetes patients. * Patients with acute diabetic complications (including unexplained severe hypoglycemia in the last 6 months). * Previous treatment with insulin for more than 1 month cumulatively in last 1 year, or treatment with insulin in the last 3 months before the screening. * Known hypoglycemia unawareness or recurrent hypoglycemia. * Hypersensitivity to study drug or its excipients. * Any clinically significant acute major organ or systemic disease, or any other situation judged by the Investigator, that is difficult for the 24 weeks follow-up. * Pregnancy or breastfeeding women. * Have any mental disorders, lack self-control or not able to express accurately. * Involved in another clinical trial simultaneously or within a 1 month before start of trial. 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 |
|---|---|
| Percentage of patients with HbA1c <7% achievement | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving HbA1c <7% without hypoglycemia | 24 weeks |
| Change in body weight in each treatment arm | Baseline to 24 weeks |
| Percentage of patients achieving HbA1c <=6.5% | 24 weeks |
| Percentage of patients achieving FPG target with HbA1c <7% | 24 weeks |
| Percentage of patients achieving the FPG target without hypoglycemia | 24 weeks |
| Percentage of patients achieving FPG target | 24 weeks |
| Percentage of patients achieving PPG target (2-hour post-breakfast <10 mmol/L) | 24 weeks |
| Change from baseline in HbA1c | Baseline to 24 weeks |
| Change in FPG | 8 weeks to 24 weeks |
| Change in PPG | Baseline to 24 weeks |
| Percentage of patients experienced hypoglycemic events | 24 weeks |
| Change in insulin doses in each arm | 1 week to 24 weeks |
Countries
China
Outcome results
None listed