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

December 17, 2023 updated by: Tonghua Dongbao Pharmaceutical Co.,Ltd

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®

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

563

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hongwei Wang
  • Phone Number: 925 86 10 52165902

Study Locations

  • China
    • Shandong
      • Weifang, Shandong, China
        • Affiliated hospital of Weifang Medical University
    • Shanghai
      • Shanghai, Shanghai, China
        • The 6th people's hospital of Shanghai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: insulin Aspart injection
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 prior to three meals every day, while subcutaneous injection of Lantus at bedtime.
Active Comparator: insulin Aspart injection (NovoRapid)
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 injection (NovoRapid) prior to three meals every day, while subcutaneous injection of Lantus at bedtime.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change of relative baseline HbA1c
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tonghua Dongbao Pharmaceutical Co.,Ltd

Investigators

  • Principal Investigator: WP Jia, The 6th people's hospital of Shanghai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2015

Primary Completion (Actual)

August 12, 2016

Study Completion (Actual)

August 12, 2016

Study Registration Dates

First Submitted

June 5, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimated)

July 8, 2015

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 17, 2023

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DB021L012015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on insulin Aspart injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe