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

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ClinicalTrials.gov Identifier: NCT02491528
Recruitment Status : Unknown
Verified July 2015 by Weiping Jia, Tonghua Dongbao Pharmaceutical Co.,Ltd.
Recruitment status was:  Recruiting
First Posted : July 8, 2015
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Weiping Jia, Tonghua Dongbao Pharmaceutical Co.,Ltd

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.

Condition or disease Intervention/treatment Phase
Diabetes Biological: insulin Aspart injection Biological: insulin Aspart injection (NovoRapid) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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®
Study Start Date : June 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The change of relative baseline HbA1c [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491528


Contacts
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Contact: Hongwei Wang 86 10 52165902 ext 925

Locations
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China, Shandong
Affiliated hospital of Weifang Medical University Recruiting
Weifang, Shandong, China
China, Shanghai
The 6th people's hospital of Shanghai Not yet recruiting
Shanghai, Shanghai, China
Sponsors and Collaborators
Weiping Jia
Investigators
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Principal Investigator: WP Jia The 6th people's hospital of Shanghai

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Responsible Party: Weiping Jia, Chief physician, Tonghua Dongbao Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT02491528     History of Changes
Other Study ID Numbers: DB021L012015
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs