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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™)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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).

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427920


Locations
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Argentina
Novo Nordisk Investigational Site
Capital Federal, Argentina, 1405
Novo Nordisk Investigational Site
Capital Federal, Argentina, C1056ABJ
Novo Nordisk Investigational Site
Chacabuco, Argentina, B6740ELF
Novo Nordisk Investigational Site
Cordoba, Argentina, 5000
Novo Nordisk Investigational Site
Córdoba, Argentina, X5006IKK
China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100034
China, Chongqing
Novo Nordisk Investigational Site
ChongQing, Chongqing, China, 404000
China, Gansu
Novo Nordisk Investigational Site
Lanzhou, Gansu, China, 730000
China, Henan
Novo Nordisk Investigational Site
Zhengzhou, Henan, China, 450052
China, Liaoning
Novo Nordisk Investigational Site
Dalian, Liaoning, China, 116033
China
Novo Nordisk Investigational Site
Tianjin, China, 300211
India
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India, 380 015
Novo Nordisk Investigational Site
Belgaum, Karnataka, India, 590001
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400007
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600028
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu, India, 641018
Novo Nordisk Investigational Site
Kolkata, West Bengal, India, 700054
Novo Nordisk Investigational Site
New Delhi, India, 110085
Novo Nordisk Investigational Site
Thriruvananthapuram, India, 695 032
Poland
Novo Nordisk Investigational Site
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
Spain
Novo Nordisk Investigational Site
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
United Kingdom
Novo Nordisk Investigational Site
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01427920    
Other Study ID Numbers: BIASP-3878
2010-024303-27 ( EudraCT Number )
U1111-1118-4096 ( Other Identifier: WHO )
First Posted: September 2, 2011    Key Record Dates
Results First Posted: September 12, 2013
Last Update Posted: February 24, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs