Clinical trial NCT01427920: 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: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-09-02
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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)

Primary outcomes:
measure: Change in HbA1c (Glycosylated Haemoglobin) - FAS
timeFrame: Week 0, week 20
measure: Change in HbA1c (Glycosylated Haemoglobin) - PP
timeFrame: Week 0, week 20
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values)
timeFrame: Week 0, week 20
measure: Number of Treatment Emergent Hypoglycaemic Episodes
timeFrame: Week 0 to week 20
measure: Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
timeFrame: Week 0
measure: Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
timeFrame: Week 4
measure: Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
timeFrame: Week 20
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: Novo Nordisk Investigational Site
city: Capital Federal
country: Argentina
facility: Novo Nordisk Investigational Site
city: Chacabuco
country: Argentina
facility: Novo Nordisk Investigational Site
city: Cordoba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Córdoba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: ChongQing
country: China
facility: Novo Nordisk Investigational Site
state: Chongqing
city: Lanzhou
country: China
facility: Novo Nordisk Investigational Site
state: Gansu
city: Zhengzhou
country: China
facility: Novo Nordisk Investigational Site
state: Henan
city: Dalian
country: China
facility: Novo Nordisk Investigational Site
state: Liaoning
city: Tianjin
country: China
facility: Novo Nordisk Investigational Site
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Belgaum
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
state: West Bengal
city: New Delhi
country: India
facility: Novo Nordisk Investigational Site
city: Thriruvananthapuram
country: India
facility: Novo Nordisk Investigational Site
city: Bialystok
country: Poland
facility: Novo Nordisk Investigational Site
city: Gdansk
country: Poland
facility: Novo Nordisk Investigational Site
city: Lodz
country: Poland
facility: Novo Nordisk Investigational Site
city: Lubin
country: Poland
facility: Novo Nordisk Investigational Site
city: Ruda Slaska
country: Poland
facility: Novo Nordisk Investigational Site
city: Sopot
country: Poland
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Wroclaw
country: Poland
facility: Novo Nordisk Investigational Site
city: Almería
country: Spain
facility: Novo Nordisk Investigational Site
city: Centelles (Barcelona)
country: Spain
facility: Novo Nordisk Investigational Site
city: La Roca del Vallés (Barcelona)
country: Spain
facility: Novo Nordisk Investigational Site
city: Málaga
country: Spain
facility: Novo Nordisk Investigational Site
city: Palma de Mallorca
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Vic (Barcelona)
country: Spain
facility: Novo Nordisk Investigational Site
city: Doncaster
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Ipswich
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Northwood
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Reading
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Scunthorpe
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Wirral, Merseyside
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.