A Phase III Study of Insulin Aspart Injection to Evaluate the Efficacy and Safety
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®
1 other identifier
interventional
563
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes
Started Jun 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2015
CompletedStudy Start
First participant enrolled
June 19, 2015
CompletedFirst Posted
Study publicly available on registry
July 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2016
CompletedDecember 22, 2023
July 1, 2015
1.2 years
June 5, 2015
December 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The change of relative baseline HbA1c
24 weeks
Study Arms (2)
insulin Aspart injection
EXPERIMENTALSubcutaneous injection of insulin Aspart prior to three meals every day, while subcutaneous injection of Lantus at bedtime.
insulin Aspart injection (NovoRapid)
ACTIVE COMPARATORSubcutaneous injection of insulin Aspart (NovoRapid) prior to three meals every day, while subcutaneous injection of Lantus at bedtime.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients were diagnosed with diabetes；
- BMI≤35.0 kg/m2；
- Insulin therapy for at least 3 months before recruitment；
- HbA1c7\~13%
You may not qualify if:
- Patients to study drug allergy；
- to Liver and kidney impairment；
- Liver and kidney impairment；
- used systemic steroid treatment in past 2 months .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Affiliated hospital of Weifang Medical University
Weifang, Shandong, China
The 6th people's hospital of Shanghai
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
WP Jia
The 6th people's hospital of Shanghai
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2015
First Posted
July 8, 2015
Study Start
June 19, 2015
Primary Completion
August 12, 2016
Study Completion
August 12, 2016
Last Updated
December 22, 2023
Record last verified: 2015-07