Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Insulin human/Insuman Comb 25 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Insuman Comb 25 | EXPERIMENTAL | Insuman Comb 25 will be self-injected subcutaneously twice daily 30-45 minutes before breakfast and dinner. The dose will be adjusted individually by monitoring the blood glucose values and symptoms, and following China guideline. |
| Novolin® 30R | ACTIVE_COMPARATOR | Novolin® 30R will be self-injected subcutaneously twice daily within 30 minutes before breakfast and dinner. The dose will be adjusted individually by monitoring the blood glucose values and symptoms, and following China guideline and the package insert of Novolin® 30R |
| Name | Type | Description |
|---|---|---|
| Insulin human/Insuman Comb 25 (HR1799) | DRUG | Pharmaceutical form:Suspension Route of administration: Subcutaneous |
| Insulin human/Novolin® 30R | DRUG | Pharmaceutical form:Suspension Route of administration: Subcutaneous |
Inclusion criteria: * Type 2 diabetes mellitus patients, as defined by World Health Organization (WHO), diagnosed for at least 1 year at the time of screening visit who are under premix insulin therapy, with or without oral anti-diabetic drug (OAD) * Signed written informed consent Exclusion crite...