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

NCT ID: NCT02491528

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

563 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-19

Study Completion Date

2016-08-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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insulin Aspart injection

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

Group Type EXPERIMENTAL

insulin Aspart injection

Intervention Type BIOLOGICAL

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

insulin Aspart injection (NovoRapid)

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

Group Type ACTIVE_COMPARATOR

insulin Aspart injection (NovoRapid)

Intervention Type BIOLOGICAL

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

Interventions

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insulin Aspart injection

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

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tonghua Dongbao Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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WP Jia

Role: PRINCIPAL_INVESTIGATOR

The 6th people's hospital of Shanghai

Locations

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Affiliated hospital of Weifang Medical University

Weifang, Shandong, China

Site Status

The 6th people's hospital of Shanghai

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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DB021L012015

Identifier Type: -

Identifier Source: org_study_id