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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...
Insulin human/Insuman Comb 25 is used to treat Type 2 Diabetes Mellitus in adults. It is a biphasic insulin product given twice daily to patients who require insulin therapy. The Phase 3 program studied it in patients aged 18 years and older in China.
Insulin human/Insuman Comb 25 works as an agonist at the insulin receptor, known as INSR. Binding to INSR activates signaling that promotes glucose uptake into tissues and lowers blood glucose. The product combines a rapid-acting and an intermediate-acting insulin component in a fixed 25/75 ratio.
Insulin human/Insuman Comb 25 is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program for this biphasic insulin product in Type 2 Diabetes Mellitus.
Insulin human/Insuman Comb 25 is in Phase 3 development for Type 2 Diabetes Mellitus. The Phase 3 trial has been completed, and no active trials are currently listed. It is an investigational product and is not described as FDA approved.
Insulin human/Insuman Comb 25 has been studied in one completed Phase 3 trial, NCT01353469. That randomized, active-controlled study enrolled 485 adults with Type 2 Diabetes Mellitus in China and compared Insuman Comb 25 with Novolin 30R given twice daily over 24 weeks.
Yes, Insulin human/Insuman Comb 25 is also known as Insulin human/Insuman Comb 25 (HR1799). HR1799 is an alternative identifier used for the same Sanofi biphasic insulin product being studied in Type 2 Diabetes Mellitus.