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™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01427920
First received: August 31, 2011
Last updated: October 9, 2013
Last verified: October 2013

August 31, 2011
October 9, 2013
September 2011
July 2012   (final data collection date for primary outcome measure)
  • Change in HbA1c (Glycosylated Haemoglobin) - FAS [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in per protocol (PP) analysis set.
Change in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01427920 on ClinicalTrials.gov Archive Site
  • Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values) [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Change in fasting plasma glucose (FPG) (central laboratory values) [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Time Frame: from week 0 to week 20 ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) [ Time Frame: Weeks 0, 4 and 20 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
348
July 2012
July 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   China,   India,   Poland,   United Kingdom
 
NCT01427920
BIASP-3878, 2010-024303-27, U1111-1118-4096
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Annette Stender Novo Nordisk A/S
Novo Nordisk A/S
October 2013

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