Clinical trial NCT02453685: A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients
Official title: A 32-week Randomised, Multinational, Treat-to-target, Open Label, Parallel Group Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp) 30 and Basal-bolus Therapy With Insulin Glargine and Insulin Aspart in Insulin naïve Type 2 Diabetic Patients Inadequately Controlled on Oral Anti-diabetic Therapy
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: 2015-05-25
Enrollment: 335
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 is conducted globally. The aim of this trial is to compare stepwise insulin intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately controlled on oral anti-diabetic therapy.


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
* Male or female, age at least 18 years at the time of signing informed consent
* Type 2 diabetes subjects clinically diagnosed at least 6 months prior to screening
* Treatment with stable daily dose (for at least 90 days prior to screening) of: - Metformin (equal or above 1000 mg or maximum tolerated dose documented in the patient medical record) and - Sulfonylurea - and willing to discontinue any other oral antidiabetic drugs containing insulin secretagogues, DPP4i (dipeptidyl peptidase-4 inhibitor), SGLT2 (sodium glucose co-transporter 2), colesevelam, bromocriptin and/or combination products at randomisation
* Insulin-naïve. Short term insulin treatment for acute illnesses for a total of 14 days or less is allowed as is prior insulin treatment for gestational diabetes
* HbA1c (glycosylated haemoglobin) 7.0-9.5 % (both inclusive) analysed by central laboratory
* Willing to consume 3 main meals daily (morning, mid-day and evening) throughout the entire trial. The definition for 'main meal' will be according to the investigator's discretion

Exclusion Criteria:

* Anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism, in excess of 14 days (i.e. sibutramine, orlistat, thyroid hormones, systemic corticosteroids and other weight loss/modifying agents)
* Impaired liver function, defined as ALT (alanine aminotransferase) at least 2.5 times upper limit of normal (central laboratory value measured at screening visit)
* Inadequately treated high blood pressure defined as Class 2 hypertension or higher (i.e. systolic blood pressure equal to or above 160 mm Hg or diastolic equal to or above 100 mm Hg) in accordance with the National High Blood Pressure Education Program, 7th Joint National Committee1 and ESH/ESC 2013 Guidelines2
* Within the past 180 days prior to randomisation, any of the following: Myocardial Infarction, stroke or hospitalization for unstable angina and /or transient ischemic attack

Primary outcomes:
measure: Change in HbA1c (Glycosylated Haemoglobin)
timeFrame: Week 0, week 32
Secondary outcomes:
measure: HbA1c Below 7.0% Without Severe Hypoglycaemic Episodes
timeFrame: After 32 weeks of treatment (yes/no)
measure: Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) and the Novo Nordisk Definitions
timeFrame: Weeks 0-32
measure: Total Daily Insulin Dose
timeFrame: Weeks 0-32
Other outcomes:
Locations:
city: Broadmeadow
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Ipswich
country: Australia
facility: Novo Nordisk Investigational Site
state: Queensland
city: Fitzroy
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Petrich
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sliven
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Nyíregyhaza
country: Hungary
facility: Novo Nordisk Investigational Site
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Madurai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Vellore
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: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Serbia
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Serbia
facility: Novo Nordisk Investigational Site
city: Nis
country: Serbia
facility: Novo Nordisk Investigational Site
city: Bangkoknoi, Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Khon Kaen
country: Thailand
facility: Novo Nordisk Investigational Site
city: Antalya
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Malatya
country: Turkey
facility: Novo Nordisk Investigational Site
city: Rize
country: Turkey
facility: Novo Nordisk Investigational Site
city: Ajman
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Dubai
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Ras Al Khaimah
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Umm Al Quwain
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Linjawi S, Lee BW, Tabak O, Lovdahl S, Werther S, Abusnana S. A 32-Week Randomized Comparison of Stepwise Insulin Intensification of Biphasic Insulin Aspart (BIAsp 30) Versus Basal-Bolus Therapy in Insulin-Naive Patients with Type 2 Diabetes. Diabetes Ther. 2018 Feb;9(1):1-11. doi: 10.1007/s13300-017-0334-8. Epub 2017 Nov 11.