Clinical trial NCT01618214: Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes
Official title: A 20-week, Randomised, Open-label, 2-armed, Parallel Group Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes Inadequately Controlled With Premixed Human Insulin
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: 2012-06-13
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes inadequately controlled with premixed human insulin. Subjects to continue their OAD background treatment: Metformin plus/minus alpha-glucosidase inhibitor.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
* Currently treated with premixed/self-mixed human insulin (proportion of short-acting insulin is equal to or lower than 30%) BID (twice daily) combined with metformin with or without alpha-glucosidase inhibitor for at least 3 months prior to screening visit (Visit 1) with the minimum dose stated: Metformin: at least 1500 mg/day or maximum tolerated dose at least 1000 mg/day (with unchanged dosing within 3 months prior to Visit 1) OR alpha-glucosidase inhibitors: acarbose or miglitol at least 150 mg/day, or voglibose at least 0.6 mg/day
* Total daily insulin dose below 1.4 IU/Kg
* HbA1c above or equal to 7.0% and below or equal to 9.5% (central laboratory)
* Body Mass Index (BMI) below or equal to 35.0 kg/m\^2

Exclusion Criteria:

* Treatment with any insulin secretagogue, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to Visit 1
* Previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more than 14 days
* Previous use of any insulin other than premixed/self-mixed human insulin (proportion of short acting insulin equal to or lower than 30%) BID within 3 month prior to Visit 1
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Known proliferative retinopathy or maculopathy requiring treatment

Primary outcomes:
measure: Change From Baseline in HbA1c (Glycosylated Haemoglobin)
timeFrame: Week 0, week 20
Secondary outcomes:
measure: Percentage of Subjects Achieving HbA1c Below 7.0%
timeFrame: After 20 weeks of treatment
measure: Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
timeFrame: After 20 weeks of treatment
measure: Change From Baseline in FPG (Fasting Plasma Glucose)
timeFrame: Week 0, week 20
measure: Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
timeFrame: Week 0 to week 20 (inclusive).
Other outcomes:
Locations:
city: Hefei
country: China
facility: Novo Nordisk Investigational Site
state: Anhui
city: Hefei
country: China
facility: Novo Nordisk Investigational Site
state: Anhui
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Chongqing
country: China
facility: Novo Nordisk Investigational Site
state: Chongqing
city: ChongQing
country: China
facility: Novo Nordisk Investigational Site
state: Chongqing
city: Guangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Guangdong
city: Shijiazhuang
country: China
facility: Novo Nordisk Investigational Site
state: Hebei
city: Shijiazhuang
country: China
facility: Novo Nordisk Investigational Site
state: Hebei
city: Wuhan
country: China
facility: Novo Nordisk Investigational Site
state: Hubei
city: Tongliao
country: China
facility: Novo Nordisk Investigational Site
state: Inner Mongolia
city: Nanjing
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Yangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Nanchang
country: China
facility: Novo Nordisk Investigational Site
state: Jiangxi
city: Changchun
country: China
facility: Novo Nordisk Investigational Site
state: Jilin
city: Siping
country: China
facility: Novo Nordisk Investigational Site
state: Jilin
city: Xi'an
country: China
facility: Novo Nordisk Investigational Site
state: Shaanxi
city: Jinan
country: China
facility: Novo Nordisk Investigational Site
state: Shandong
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Hangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Zhejiang
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Yang W, Zhu L, Meng B, Liu Y, Wang W, Ye S, Sun L, Miao H, Guo L, Wang Z, Lv X, Li Q, Ji Q, Zhao W, Yang G. Subject-driven titration of biphasic insulin aspart 30 twice daily is non-inferior to investigator-driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open-label, parallel-group, multicenter trial. J Diabetes Investig. 2016 Jan;7(1):85-93. doi: 10.1111/jdi.12364. Epub 2015 May 25.