Type 2 Diabetes mellitus
Conditions
Interventions
G+:basal insulin based treatment
PM-2:twice-daily premixed insulin
Sponsors
The General Hospital of People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 and 70 years; 2. HbA1c >7.5%, and =11%; 3. FPG >7 mmol/L; 4. Fasting C peptide >1 ng/ml; 5. Type 2 diabetes (T2DM) patients with diabetes diagnosis between 2 and 10 years (World Health Organization 1999 T2DM diagnose criteria); 6. Continuous treatment with stable doses of metformin (=1 g/day) and 1 OAD (at least half maximum dose) for more than 3 months prior to screening; 7. Body mass index =21 kg/m2, and <40 kg/m2.
Exclusion criteria
Exclusion criteria: 1. More than 7 consecutive days of insulin treatment within the 12 months except for acute disease or surgery; 2. Diabetes other than T2DM (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake); 3. History of hypoglycemia unawareness or recurrent hypoglycemia or severe hypoglycemia within the past 12 months; 4. History of sensitivity to the study drugs or to drugs with a similar chemical structure; 5. Pregnancy or planned pregnancy or current lactation (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method); 6. Acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma) within the past 12 months; 7. Significant diabetic complications and serious disease, e.g., symptomatic autonomic neuropathy, gastroparesis, unstable angina or active proliferative retinopathy; 8. Acute infections which may affect BG control within the past 4 weeks; 9. Malignancy, including leukemia and lymphoma, within the past 5 years; 10. Active liver disease, alanine transaminase (ALT) and/or aspartate aminotransferase (AST) greater than two times the upper limit of the reference range at screening as defined by the local laboratory; 11. Impaired renal function, defined as but not limited to, serum creatinine levels =1.5 mg/dL (132 µmol/L) for males and =1.4 mg/dL (123 µmol/L) for females or presence of macroproteinuria (>2 g/day); 12. Any contraindications of sitagliptin, vildagliptin, acarbose and repaglinide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c change from baseline to week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with FPG <6.1 mmol/L at week 12 and week 24;Percentage of patients with FPG <7 mmol/L at week 12 and week 24;Percentage of patients with HbA1c <7% at week 12 and week 24;Incidence of hypoglycemia;FPG change from baseline to week 24;Total daily insulin dose at week 24;Change of body weight from baseline to week 24;Daily BG variation at week 24;Patient satisfaction estimated by questionnaire;Subgroup analysis;Percentage of patients with FPG<6.1mmol/L without hypoglycemia at week 12 and week 24.;Percentage of patients with FPG<7 mmol/L without hypoglycemia at week 12 and week 24; | — |
Countries
China
Contacts
Public ContactChenfei Gu
Outcome results
None listed