A Phase 3 interventional study of insulin Aspart injection and insulin Aspart injection (NovoRapid) in Diabetes, sponsored by Tonghua Dongbao Pharmaceutical Co.,Ltd. Completed at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-22.
Sponsored by Tonghua Dongbao Pharmaceutical Co.,Ltd · Phase 3, Interventional, and Treatment
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.
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.
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 563 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Tonghua Dongbao Pharmaceutical Co.,Ltd is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Subcutaneous injection of insulin Aspart prior to three meals every day, while subcutaneous injection of Lantus at bedtime.
Biological: insulin Aspart injection
Subcutaneous injection of insulin Aspart (NovoRapid) prior to three meals every day, while subcutaneous injection of Lantus at bedtime.
Biological: insulin Aspart injection (NovoRapid)
Subcutaneous injection of insulin Aspart prior to three meals every day, while subcutaneous injection of Lantus at bedtime.
Subcutaneous injection of insulin Aspart injection (NovoRapid) prior to three meals every day, while subcutaneous injection of Lantus at bedtime.
The change of relative baseline HbA1c
Time frame: 24 weeks
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Insulin Aspart
Tonghua Dongbao Pharmaceutical Co.,Ltd