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A Phase III Study of Insulin Aspart Injection to Evaluate the Efficacy and Safety

NCT02491528 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 563

Last updated 2023-12-22

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

insulin Aspart injection (NovoRapid)

Subcutaneous injection of insulin Aspart injection (NovoRapid) prior to three meals every day, while subcutaneous injection of Lantus at bedtime.

BIOLOGICAL

insulin Aspart injection

Subcutaneous injection of insulin Aspart prior to three meals every day, while subcutaneous injection of Lantus at bedtime.

Sponsors & Collaborators

  • Tonghua Dongbao Pharmaceutical Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • WP Jia · The 6th people's hospital of Shanghai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-19
Primary Completion
2016-08-12
Completion
2016-08-12

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02491528 on ClinicalTrials.gov