Type 2 diabetes mellitus
Conditions
Interventions
standard initial dose arm:Insulin glargine (Lantus) treatmen
higher initial dose arm:Insulin glargine (Lantus) treatmen
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Type 2 diabetes patients with diabetes diagnosis at least 2 years; ; 3.Continuous treatment with stable doses of 2-3 OADs for more than three months prior to randomization, among which metformin =1.5 g/day or at maximum tolerated dose; 4. HbA1c 7.5% to 11%; 5. FPG >9 mmol/L; 6. BMI 25 to 40 kg/m^2; 7. Ability and willingness to perform self-monitoring of blood glucose (SMBG) using the Sponsor-provided glucose meter and to complete the patient diary; 8. Willingness and ability to comply with the study protocol; 9. Signed informed consent obtained prior any study procedure.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity / intolerance to insulin glargine or any of its excipients; 2. History of hypoglycemia unawareness; 3. Unexplained hypoglycemia in the past 6 months; 4. Pregnancy or planned pregnancy or current lactation; 5. Acute diabetic complications; 6. History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the previous 12 months; 7. Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by retina examination or disease history record, in the 2 years prior to study entry; 8. Impaired renal function defined as, but not limited to, serum creatinine levels =1.5 mg/dL (132 umol/L) for males and =1.4 mg/dL (123 umol/L) for females or presence of macroproteinuria (>2 g/day); 9. Active liver disease (alanine transaminase [ALT] greater than two times the upper limit of the reference range, as defined by the local laboratory).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall hypoglycemic incidence (with confirmed hypoglycemia [=3.9 mmol/L]); | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving HbA1c <7%.;Percentage of patients achieving FPG target (<5.6, <6.1, and <7.0 mmol/L).;Accumulated percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L);Change from baseline in HbA1c;Change from baseline in Fasting Plasma Glucose;Change from baseline in Post Prandial Glucose;Change in body weight;Change in insulin dose;Number of overall hypoglycemic events (with severe or confirmed hypoglycemia) annually;Number of nocturnal hypoglycemic events annually;Number of severe hypoglycemic events annually; | — |
Countries
China
Contacts
Public ContactZHANG Tong
SANOFI (CHINA) INVESTMENT CO., LTD. SHANGHAI BRANCH
Outcome results
None listed