Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT02491528
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2015-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase III Study of Insulin Aspart Injection to Evaluate the Efficacy and Safety
Sponsor:
Tonghua Dongbao Pharmaceutical Co.,Ltd
Organization:
Study Overview
Official Title:
A Multi-center, Randomized, Open-label, Parallel-group, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Insulin Aspart Injection in Patients With Diabetes Mellitus Compared to NovoRapid®
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter, randomized, open, parallel group, active-controlled study. The study period is 25 to 26 weeks, including screening period of 1-2 weeks and treatment period of 24 weeks.
Detailed Description:
After the screening visit, all patients who met all inclusion criteria and do not meet any of the exclusion criteria were randomized into the experimental group or the controlled group. The subjects in the experimental arm will receive insulin aspart injection combined with basal insulin (Lantus ®), and the subjects in the controlled arm will receive NovoRapid ® (active control) combined with basal insulin (Lantus ®). The experimental drug or the controlled drug will be administered subcutaneously prior to three meals (or can be administered immediately after meal if necessary), and the basal insulin (Lantus ®) will be administered at bedtime. The treatment period is 24 weeks, during which the subjects will be followed up at the clincic cetres at 1, 2, 4, 8, 12, 18, 24 weeks of treatment. At the end of 24-week treatment, if the adverse events continue, the subjects will be followed until recovery or stabilization of the AEs.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: