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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™)

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ClinicalTrials.gov Identifier: NCT01427920
Recruitment Status : Completed
First Posted : September 2, 2011
Results First Posted : September 12, 2013
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE August 31, 2011
First Posted Date  ICMJE September 2, 2011
Results First Submitted Date  ICMJE July 3, 2013
Results First Posted Date  ICMJE September 12, 2013
Last Update Posted Date February 24, 2017
Study Start Date  ICMJE September 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
  • 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).
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2011)
Change in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 20 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2011)
  • Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values) [ Time Frame: Week 0, week 20 ]
  • Number of hypoglycaemic episodes [ Time Frame: from week 0 to week 20 ]
  • Patient Reported Outcomes evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) [ Time Frame: Weeks 0, 4 and 20 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Subject-driven titration BIAsp 30 (BID) + metformin
    The subjects performed the titration of BIAsp 30 dose.
    Intervention: Drug: biphasic insulin aspart 30
  • Active Comparator: Investigator-driven titration BIAsp 30 (BID) + metformin
    The investigator performed the titration of BIAsp 30 dose.
    Intervention: Drug: biphasic insulin aspart 30
Publications * Gao Y, Luquez C, Lynggaard H, Andersen H, Saboo B. The SimpleMix study with biphasic insulin aspart 30: a randomized controlled trial investigating patient-driven titration versus investigator-driven titration. Curr Med Res Opin. 2014 Dec;30(12):2483-92. doi: 10.1185/03007995.2014.960512. Epub 2014 Sep 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2012)
348
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2011)
338
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   China,   India,   Poland,   Spain,   United Kingdom
Removed Location Countries Turkey
 
Administrative Information
NCT Number  ICMJE NCT01427920
Other Study ID Numbers  ICMJE BIASP-3878
2010-024303-27 ( EudraCT Number )
U1111-1118-4096 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP