Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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®

ID
Name
DB021L012015
Description
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.
Trial arms
Trial start
2015-06-19
Estimated PCD
2016-08-12
Trial end
2016-08-12
Status
Completed
Phase
Early phase I
Treatment
insulin Aspart injection
Subcutaneous injection of insulin Aspart prior to three meals every day, while subcutaneous injection of Lantus at bedtime.
Arms:
insulin Aspart injection
insulin Aspart injection (NovoRapid)
Subcutaneous injection of insulin Aspart injection (NovoRapid) prior to three meals every day, while subcutaneous injection of Lantus at bedtime.
Arms:
insulin Aspart injection (NovoRapid)
Size
563
Primary endpoint
The change of relative baseline HbA1c
24 weeks
Eligibility criteria
Inclusion Criteria: * Patients were diagnosed with diabetes； * BMI≤35.0 kg/m2； * Insulin therapy for at least 3 months before recruitment； * HbA1c7\~13% Exclusion Criteria: * Patients to study drug allergy； * to Liver and kidney impairment； * Liver and kidney impairment； * used systemic steroid treatment in past 2 months .
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 563, 'type': 'ACTUAL'}}
Updated at
2023-12-22

1 organization

1 product

1 indication

Organization
Tonghua Dongbao Pharmaceutical Co.
Product
Insulin Aspart
Indication
Diabetes