Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

January 5, 2017 updated by: Novo Nordisk A/S

A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin naïve Subjects With Type 2 Diabetes

This trial is conducted in Africa, Asia, Europe, Oceania and South America.

This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

480

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

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Novo Nordisk Investigational Site
      • Ciudad Autonoma de Bs As, Argentina, C1405CWB
        • Novo Nordisk Investigational Site
      • Ciudad Autónoma de BsAs, Argentina, C1406FWY
        • Novo Nordisk Investigational Site
      • Mar del Plata, Argentina, B7602CBM
        • Novo Nordisk Investigational Site
  • Austria
      • Bregenz, Austria, A - 6900
        • Novo Nordisk Investigational Site
      • Feldkirch, Austria, 6807
        • Novo Nordisk Investigational Site
      • Traisen, Austria, 3160
        • Novo Nordisk Investigational Site
      • Wels, Austria, 4600
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1100
        • Novo Nordisk Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 656 91
        • Novo Nordisk Investigational Site
      • Hradec Kralove, Czech Republic, 500 05
        • Novo Nordisk Investigational Site
  • Former Serbia and Montenegro
      • Kragujevac, Former Serbia and Montenegro, 34000
        • Novo Nordisk Investigational Site
      • Nis, Former Serbia and Montenegro, 18000
        • Novo Nordisk Investigational Site
      • Novi Sad, Former Serbia and Montenegro, 21000
        • Novo Nordisk Investigational Site
  • France
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • Limoges, France, 87042
        • Novo Nordisk Investigational Site
      • Mougins, France, 06250
        • Novo Nordisk Investigational Site
      • NEVERS cedex, France, 58033
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
      • Pointe à Pitre, France, 97159
        • Novo Nordisk Investigational Site
  • India
      • Visakhapatnam, India, 530001
        • Novo Nordisk Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Novo Nordisk Investigational Site
    • Haryana
      • Karnal, Haryana, India, 132001
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560043
        • Novo Nordisk Investigational Site
  • Malaysia
      • Cheras, Malaysia, 56000
        • Novo Nordisk Investigational Site
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Novo Nordisk Investigational Site
      • Pulau Pinang, Malaysia, 10990
        • Novo Nordisk Investigational Site
  • Mexico
      • Guadalajara, Mexico, 44600
        • Novo Nordisk Investigational Site
      • Guadalajara, Mexico, 44620
        • Novo Nordisk Investigational Site
      • Pachuca, Mexico, 42060
        • Novo Nordisk Investigational Site
  • Netherlands
      • Almere, Netherlands, 1311RL
        • Novo Nordisk Investigational Site
      • Groningen, Netherlands, 9711 SG
        • Novo Nordisk Investigational Site
      • Leiderdorp, Netherlands, 2352 RA
        • Novo Nordisk Investigational Site
      • Rotterdam, Netherlands, 3021 HC
        • Novo Nordisk Investigational Site
      • Zoetermeer, Netherlands, 2724 EK
        • Novo Nordisk Investigational Site
  • Philippines
      • Manila, Philippines, 1014
        • Novo Nordisk Investigational Site
      • Quezon City, Philippines, 1102
        • Novo Nordisk Investigational Site
      • Quezon City, Philippines, 1100
        • Novo Nordisk Investigational Site
  • Poland
      • Bialystok, Poland, 15-276
        • Novo Nordisk Investigational Site
      • Bydgoszcz, Poland, 85-094
        • Novo Nordisk Investigational Site
      • Gdansk, Poland, 80-858
        • Novo Nordisk Investigational Site
      • Gdynia, Poland, 81-366
        • Novo Nordisk Investigational Site
      • Krakow, Poland, 31-501
        • Novo Nordisk Investigational Site
      • Lodz, Poland, 90-153
        • Novo Nordisk Investigational Site
      • Lubin, Poland, 59-301
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-081
        • Novo Nordisk Investigational Site
      • Olsztyn, Poland, 10-561
        • Novo Nordisk Investigational Site
      • Poznan, Poland, 60-821
        • Novo Nordisk Investigational Site
      • Rzeszow, Poland, 35-301
        • Novo Nordisk Investigational Site
      • Szczecin, Poland, 71-455
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 02-507
        • Novo Nordisk Investigational Site
      • Zabrze, Poland, 41-800
        • Novo Nordisk Investigational Site
  • Romania
      • Botosani, Romania, 710224
        • Novo Nordisk Investigational Site
      • Bucharest, Romania, 020475
        • Novo Nordisk Investigational Site
      • Galati, Romania, 800371
        • Novo Nordisk Investigational Site
      • Satu Mare, Romania, 440055
        • Novo Nordisk Investigational Site
      • Targoviste, Romania, 130083
        • Novo Nordisk Investigational Site
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Novo Nordisk Investigational Site
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Novo Nordisk Investigational Site
    • North West
      • Brits, North West, South Africa, 0250
        • Novo Nordisk Investigational Site
  • Spain
      • Alzira, Spain, 46600
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28040
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28041
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29009
        • Novo Nordisk Investigational Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Novo Nordisk Investigational Site
      • Lund, Sweden, 221 85
        • Novo Nordisk Investigational Site
      • Malmö, Sweden, 205 02
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 182 88
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months
  • Ongoing stable treatment with metformin for at least 2 months
  • Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months
  • Insulin naive
  • HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values)

Exclusion Criteria:

  • Metformin contraindication according to local practice
  • TZD (thiazolidinedione) treatment for the last 5 months before trial start
  • Systemic treatment with any corticosteroid 3 months before trial start
  • Any disease or condition which according to the Investigator would interfere with the trial

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: BIAsp 30
Drug: biphasic insulin aspart
Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
Drug: metformin
Tablets, 2550 mcg. Administered once daily.
Drug: glimepiride
Tablets 2 mg. 4, 6 or 8 mg administered once daily.
Active Comparator: Glargine
Drug: metformin
Tablets, 2550 mcg. Administered once daily.
Drug: glimepiride
Tablets 2 mg. 4, 6 or 8 mg administered once daily.
Drug: insulin glargine
Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycosylated Haemoglobin A1c (HbA1c)
Time Frame: After 26 weeks of treatment
Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.
After 26 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
9-point Self-measured Plasma Glucose Profiles
Time Frame: After 26 weeks of treatment
Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL.
After 26 weeks of treatment
Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)
Time Frame: After 26 weeks of treatment
The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c <= 6.5% of haemoglobin and HbA1c < 7% of haemoglobin.
After 26 weeks of treatment
Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)
Time Frame: After 26 weeks of treatment
Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale.
After 26 weeks of treatment
Number of Hypoglycaemic Episodes
Time Frame: Weeks 0-26
Total number of hypoglycaemic episodes experienced in each treatment arm. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.
Weeks 0-26
Number of Subjects Reporting Treatment Emergent Adverse Events
Time Frame: Weeks 0-26
Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration.
Weeks 0-26

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

May 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

May 3, 2007

First Submitted That Met QC Criteria

May 3, 2007

First Posted (Estimate)

May 4, 2007

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1731
  • 2006-003288-29 (EudraCT Number)

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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