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Completed

NCT Number: NCT02491528

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Affiliated hospital of Weifang Medical University, Weifang, Shandong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

insulin Aspart injection

Biological

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

insulin Aspart injection (NovoRapid)

Biological

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

Primary outcomes

  1. The change of relative baseline HbA1c

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Tonghua Dongbao Pharmaceutical Co.,Ltd

Industry

Registry information

Official study 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®

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 8, 2015
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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