Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes

January 10, 2017 updated by: Novo Nordisk A/S

A 20-week, Randomised, Open-label, 2-armed, Parallel Group Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes Inadequately Controlled With Premixed Human Insulin

This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes inadequately controlled with premixed human insulin. Subjects to continue their OAD background treatment: Metformin plus/minus alpha-glucosidase inhibitor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

344

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Novo Nordisk Investigational Site
      • Hefei, Anhui, China, 230022
        • Novo Nordisk Investigational Site
    • Beijing
      • Beijing, Beijing, China, 100029
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 100730
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 100088
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 100700
        • Novo Nordisk Investigational Site
    • Chongqing
      • ChongQing, Chongqing, China, 404000
        • Novo Nordisk Investigational Site
      • Chongqing, Chongqing, China, 400010
        • Novo Nordisk Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Novo Nordisk Investigational Site
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Novo Nordisk Investigational Site
      • Shijiazhuang, Hebei, China, 050082
        • Novo Nordisk Investigational Site
    • Hubei
      • Wuhan, Hubei, China, 430034
        • Novo Nordisk Investigational Site
    • Inner Mongolia
      • Tongliao, Inner Mongolia, China, 028007
        • Novo Nordisk Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Novo Nordisk Investigational Site
      • Yangzhou, Jiangsu, China, 225001
        • Novo Nordisk Investigational Site
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Novo Nordisk Investigational Site
    • Jilin
      • Changchun, Jilin, China, 130041
        • Novo Nordisk Investigational Site
      • Siping, Jilin, China, 136000
        • Novo Nordisk Investigational Site
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Novo Nordisk Investigational Site
    • Shandong
      • Jinan, Shandong, China, 250013
        • Novo Nordisk Investigational Site
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Novo Nordisk Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Novo Nordisk Investigational Site

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
  • Currently treated with premixed/self-mixed human insulin (proportion of short-acting insulin is equal to or lower than 30%) BID (twice daily) combined with metformin with or without alpha-glucosidase inhibitor for at least 3 months prior to screening visit (Visit 1) with the minimum dose stated: Metformin: at least 1500 mg/day or maximum tolerated dose at least 1000 mg/day (with unchanged dosing within 3 months prior to Visit 1) OR alpha-glucosidase inhibitors: acarbose or miglitol at least 150 mg/day, or voglibose at least 0.6 mg/day
  • Total daily insulin dose below 1.4 IU/Kg
  • HbA1c above or equal to 7.0% and below or equal to 9.5% (central laboratory)
  • Body Mass Index (BMI) below or equal to 35.0 kg/m^2

Exclusion Criteria:

  • Treatment with any insulin secretagogue, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to Visit 1
  • Previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more than 14 days
  • Previous use of any insulin other than premixed/self-mixed human insulin (proportion of short acting insulin equal to or lower than 30%) BID within 3 month prior to Visit 1
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
  • Known proliferative retinopathy or maculopathy requiring treatment

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: Subject-driven titration
Drug: biphasic insulin aspart 30
Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.
Active Comparator: Investigator-driven titration
Drug: biphasic insulin aspart 30
Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Time Frame: Week 0, week 20
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).
Week 0, week 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving HbA1c Below 7.0%
Time Frame: After 20 weeks of treatment
After 20 weeks of treatment
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
Time Frame: After 20 weeks of treatment
After 20 weeks of treatment
Change From Baseline in FPG (Fasting Plasma Glucose)
Time Frame: Week 0, week 20
Week 0, week 20
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Time Frame: Week 0 to week 20 (inclusive).
Definition of a treatment emergent hypoglycemic episode: an episode occurred after the first administration of insulin or oral anti-diabetic drug, and no later than the last day on trial product. Severe hypoglycemic episode was that requiring assistance to administer carbohydrate, glucagon, or other resusciative actions. Minor hypoglycemic episode was the one with plasma glucose value < 3.1 mmol/L, either with symptoms that could be handled by subject, or without symptoms.
Week 0 to week 20 (inclusive).

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

June 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (Estimate)

June 13, 2012

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-3984
  • U1111-1126-7610 (Other Identifier: WHO)

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.

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