Diabetes Milletus
Conditions
Interventions
Two groups:Gan & Lee Injection (Ruixiulin) + Metformin versus NovoRapid + Metformin
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subjects diagnosed with Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus T2DM; 2. Current use of Metformin solely or in combination with no more than three categories of oral hypoglycemic agents (sulfonylureas, insulin secretagogues (including short-acting), glycosidase inhibitors (including oral hypoglycemic Chinese medicines containing known active ingredients)) for > 3 months, with Metformin daily total dosage stable at >=1000 mg and =3 months; 3. HbA1c 7.5% to 13%.
Exclusion criteria
Exclusion criteria: 1. BMI > 40 kg/m2; 2. Contraindications to Metformin; 3. Use of TZDs, DPP-4 inhibitors and GLP-1 analogs within 3 months prior to randomization; 4. Uncontrolled hypoglycemia or hyperglycemia in the opinion of the investigator (repetitive hypoglycemia or hyperglycemia and dose adjustment could not generate effective therapeutic effects); 5. Consecutive use of insulin for more than 14 days within 6 months before participation of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy and safety; | — |
Contacts
Public ContactXiaohui Guo
Peking University First Hospital
Outcome results
None listed