Comparison of Biphasic Insulin Aspart 30 Individually Adjusted by the Subject and the Trial Physician, Both Combined With Metformin in Subjects With Type 2 Diabetes (SimpleMix™)

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

A 20 Week Randomised, Multinational, Open Labelled, 2 Armed, Parallel Group Comparison of Twice Daily Subject Driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Versus Twice Daily Investigator-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Both in Combination With Metformin in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin Analogues

This trial was conducted in Asia, Europe and South America. The aim of this trial was to confirm efficacy of subject driven titration (individually adjusted) of biphasic insulin aspart 30 (BIAsp 30) twice daily in terms of glycaemic control assessed by change in glycosylated haemoglobin (HbA1c).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

348

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
      • Capital Federal, Argentina, C1056ABJ
        • Novo Nordisk Investigational Site
      • Capital Federal, Argentina, 1405
        • Novo Nordisk Investigational Site
      • Chacabuco, Argentina, B6740ELF
        • Novo Nordisk Investigational Site
      • Cordoba, Argentina, 5000
        • Novo Nordisk Investigational Site
      • Córdoba, Argentina, X5006IKK
        • Novo Nordisk Investigational Site
  • China
      • Tianjin, China, 300211
        • Novo Nordisk Investigational Site
    • Beijing
      • Beijing, Beijing, China, 100034
        • Novo Nordisk Investigational Site
    • Chongqing
      • ChongQing, Chongqing, China, 404000
        • Novo Nordisk Investigational Site
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Novo Nordisk Investigational Site
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Novo Nordisk Investigational Site
    • Liaoning
      • Dalian, Liaoning, China, 116033
        • Novo Nordisk Investigational Site
  • India
      • New Delhi, India, 110085
        • Novo Nordisk Investigational Site
      • Thriruvananthapuram, India, 695 032
        • Novo Nordisk Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 015
        • Novo Nordisk Investigational Site
    • Karnataka
      • Belgaum, Karnataka, India, 590001
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400007
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600028
        • Novo Nordisk Investigational Site
      • Coimbatore, Tamil Nadu, India, 641018
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkata, West Bengal, India, 700054
        • Novo Nordisk Investigational Site
  • Poland
      • Bialystok, Poland, 15-404
        • Novo Nordisk Investigational Site
      • Gdansk, Poland, 80-858
        • Novo Nordisk Investigational Site
      • Lodz, Poland, 90-242
        • Novo Nordisk Investigational Site
      • Lubin, Poland, 59-300
        • Novo Nordisk Investigational Site
      • Ruda Slaska, Poland, 41-709
        • Novo Nordisk Investigational Site
      • Sopot, Poland, 81-756
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 00-911
        • Novo Nordisk Investigational Site
      • Wroclaw, Poland, 50-127
        • Novo Nordisk Investigational Site
  • Spain
      • Almería, Spain, 04001
        • Novo Nordisk Investigational Site
      • Centelles (Barcelona), Spain, 08540
        • Novo Nordisk Investigational Site
      • La Roca del Vallés (Barcelona), Spain, 08430
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29006
        • Novo Nordisk Investigational Site
      • Palma de Mallorca, Spain, 07014
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46014
        • Novo Nordisk Investigational Site
      • Vic (Barcelona), Spain, 08500
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Doncaster, United Kingdom, DN9 2HY
        • Novo Nordisk Investigational Site
      • Ipswich, United Kingdom, IP4 5PD
        • Novo Nordisk Investigational Site
      • Manchester, United Kingdom, M41 5SL
        • Novo Nordisk Investigational Site
      • Northwood, United Kingdom, HA6 2RN
        • Novo Nordisk Investigational Site
      • Reading, United Kingdom, RG7 3SQ
        • Novo Nordisk Investigational Site
      • Scunthorpe, United Kingdom, DN15 6HX
        • Novo Nordisk Investigational Site
      • Wirral, Merseyside, United Kingdom, CH63 4JY
        • 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:

  • Diagnosed with type 2 diabetes for a minimum of 12 months prior to Visit 1 (screening)
  • Currently treated with a basal insulin analogue for at least 3 months prior to Visit 1 (screening)
  • Stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional OAD treatment. The metformin treatment must have been stable for at least 2 months prior to Visit 1 (screening)
  • HbA1c higher or equal to 7.0% and below or equal to 10.0% (one re-test within one week of screening visit was allowed. The last sample was to be conclusive)
  • Body Mass Index (BMI) below or equal to 40.0 kg/m^2
  • Able and willing to eat at least 2 main meals each day during the trial
  • Able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (SMPG), injection regimen and titrating themselves according to the protocol
  • Experience in performing self measured plasma glucose (SMPG)

Exclusion Criteria:

  • Treatment with any thiazolidinedione (TZD) and glucagon-like peptide-1 (GLP-1) receptor agonists or pramlintide within the last 3 months prior to Visit 1 (screening)
  • Impaired hepatic function defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper referenced limit (one re-test within one week of screening visit was allowed. The last sample was to be conclusive)
  • Impaired kidney function with serum creatinine above or equal to 133 micromol/L (1.5 mg/dL) for males and above or equal to 124 micromol/L (1.4 mg/dL) for females (one re-test within one week of screening visit was allowed. The last sample was to be conclusive)
  • Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure higher or equal to 180 mmHg and/or diastolic blood pressure higher or equal to 100 mmHg)
  • Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations) or bolus insulin. Previous use of pre-mixed or bolus insulin products was allowed only in case of hospitalisation or a severe condition requiring intermittent use of pre-mixed or bolus insulin products for less than 14 consecutive days, but not during the last 3 months prior to screening visit (Visit 1)

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 BIAsp 30 (BID) + metformin
The subjects performed the titration of BIAsp 30 dose.
Drug: biphasic insulin aspart 30
Administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued.
Active Comparator: Investigator-driven titration BIAsp 30 (BID) + metformin
The investigator performed the titration of BIAsp 30 dose.
Drug: biphasic insulin aspart 30
Administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values)
Time Frame: Week 0, week 20
Estimated mean change from baseline in FPG after 20 Weeks of treatment
Week 0, week 20
Number of Treatment Emergent Hypoglycaemic Episodes
Time Frame: Week 0 to week 20
A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product, and no later than one day after product administration. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Week 0 to week 20
Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
Time Frame: Week 0
From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.
Week 0
Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
Time Frame: Week 4
From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.
Week 4
Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
Time Frame: Week 20
From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.
Week 20

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

September 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

August 31, 2011

First Submitted That Met QC Criteria

September 1, 2011

First Posted (Estimate)

September 2, 2011

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-3878
  • 2010-024303-27 (EudraCT Number)
  • U1111-1118-4096 (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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