Type 2 diabetes mellitus
Conditions
Interventions
Group 1 (target: FPG <=5.6 mmol/L):Insulin glargine (Lantus) treatment
Group 2 (target: FPG <= 6.1 mmol/L):Insulin glargine (Lantus) treatment
Group 3 (target: FPG <=7.0mmol/L):Insulin glargine (Lantus) treatment
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 65 years old; 2. Type 2 diabetes patients insufficient controlled by 1-3 OADs with stable dose at least 3 months: - if on 1 OAD, provided with the following doses (including but not limited to): (1) alpha-glucosidase inhibitor: 100mg, tid.; (2) metformin: 1.5-2.0 g/day; (3) sulphonylureas: sub-maximum (half dose above) to maximum tolerated dose (details see the package inserts); (4) 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; 3. HbA1c 7% to 10.5%; 4. FPG > 7 mmol/L; 5. BMI 20 kg/m2 to 40 kg/m2; 6. Diabetes duration more than 1 year; 7. Physician decides to and the patient is willing to start basal insulin (BI) treatment; 8. Willing to join the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes patients; 2. Patients with acute diabetic complications (including unexplained severe hypoglycemia in the last 6 months); 3. 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; 4. Known hypoglycemia unawareness or recurrent hypoglycemia; 5. Hypersensitivity to study drug or its excipients; 6. 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; 7. Pregnancy or breast-feeding women; 8. Have any mental disorders, lack self-control or not able to express accurately; 9. Involved in another clinical trial simultaneously or within a 1 month before start of trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with HbA1c < 7% achievement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving HbA1c =6.5%;Percentage of patients achieving FPG target with HbA1c 7 mmol/L, > 6.1 and = 7 mmol/L, > 5.6 and = 6.1 mmol/L, > 5.0 and = 5.6 mmol/L, and = 5 mmol/L without hypoglycemia;The average time (days) to achieve the FPG target in the patients who achieving the FPG target;Subgroup analysis of control rate of HbA1c < 7% by duration of diabetes, duration of OAD treatment, baseline FPG, baseline HbA1c and age;Analysis correlation between FPG level and HbA1c reduction, control rate (HbA1c < 7%) and confirmed hypoglycemia at end of treatment; | — |
Countries
China
Contacts
Public ContactWei LIU
Outcome results
None listed