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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02453685




Registration number
NCT02453685
Ethics application status
Date submitted
21/05/2015
Date registered
25/05/2015
Date last updated
8/02/2019

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2014-003708-62
Secondary ID [2] 0 0
BIASP-4157
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - biphasic insulin aspart 30
Treatment: Drugs - insulin glargine
Treatment: Drugs - insulin aspart

Experimental: BIAsp -

Active Comparator: IGlar + IAsp -


Treatment: Drugs: biphasic insulin aspart 30
Injected s.c./subcutaneously once daily with the largest meal Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.

Treatment: Drugs: insulin glargine
Injected s.c./subcutaneously once daily at the same time every day, with the possibility of treatment intensification with insulin aspart (Basal-bolus arm) Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.

Treatment: Drugs: insulin aspart
Injected s.c./subcutaneously once daily.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c (Glycosylated Haemoglobin) - Change in HbA1c from baseline (week 0) to week 32.
Timepoint [1] 0 0
Week 0, week 32
Secondary outcome [1] 0 0
HbA1c Below 7.0% Without Severe Hypoglycaemic Episodes - Percentage of subjects with HbA1c below 7.0% after 32 weeks of randomised treatment without treatment emergent severe hypoglycaemic episodes during the last 12 weeks of treatment. Subjects withdrawn before 32 weeks were handled as non-responders. Severe hypoglycaemic episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration.
Timepoint [1] 0 0
After 32 weeks of treatment (yes/no)
Secondary outcome [2] 0 0
Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) and the Novo Nordisk Definitions - Hypoglycaemic episodes were classified as severe, Asymptomatic, Documented symptomatic, Pseudo, and Probable symptomatic as per ADA classification. As symptoms of hypoglycaemia occur below a PG level of 3.1 mmol/L, (56 mg/dL) Novo Nordisk classification included hypoglycaemia with plasma glucose (PG) levels below 3.1 mmol/L (56 mg/dL) in the definition of blood glucose confirmed hypoglycaemia. Hence, Novo Nordisk classification included following types of hypoglycaemia in addition to ADA classification: Severe hypoglycaemia, Symptomatic blood glucose confirmed hypoglycaemia, Asymptomatic blood glucose confirmed hypoglycaemia, Severe or blood glucose confirmed symptomatic hypoglycaemia, Blood glucose confirmed hypoglycaemia, and Severe or blood glucose confirmed hypoglycaemia. Reported data represents total of all hypoglycaemic episodes.
Timepoint [2] 0 0
Weeks 0-32
Secondary outcome [3] 0 0
Total Daily Insulin Dose - Total daily insulin dose in the basal bolus treatment group and in BIAsp 30 treatment group at each week of each treatment.
Timepoint [3] 0 0
Weeks 0-32

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Broadmeadow
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Coffs Harbour
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Ipswich
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Fitzroy
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
4305 - Ipswich
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Petrich
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Sliven
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Sofia
Country [4] 0 0
Hungary
State/province [4] 0 0
Budapest
Country [5] 0 0
Hungary
State/province [5] 0 0
Nyíregyhaza
Country [6] 0 0
India
State/province [6] 0 0
Andhra Pradesh
Country [7] 0 0
India
State/province [7] 0 0
Karnataka
Country [8] 0 0
India
State/province [8] 0 0
Maharashtra
Country [9] 0 0
India
State/province [9] 0 0
Tamil Nadu
Country [10] 0 0
India
State/province [10] 0 0
West Bengal
Country [11] 0 0
India
State/province [11] 0 0
New Delhi
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul
Country [13] 0 0
Serbia
State/province [13] 0 0
Belgrade
Country [14] 0 0
Serbia
State/province [14] 0 0
Nis
Country [15] 0 0
Thailand
State/province [15] 0 0
Bangkoknoi, Bangkok
Country [16] 0 0
Thailand
State/province [16] 0 0
Bangkok
Country [17] 0 0
Thailand
State/province [17] 0 0
Khon Kaen
Country [18] 0 0
Turkey
State/province [18] 0 0
Antalya
Country [19] 0 0
Turkey
State/province [19] 0 0
Istanbul
Country [20] 0 0
Turkey
State/province [20] 0 0
Malatya
Country [21] 0 0
Turkey
State/province [21] 0 0
Rize
Country [22] 0 0
United Arab Emirates
State/province [22] 0 0
Ajman
Country [23] 0 0
United Arab Emirates
State/province [23] 0 0
Dubai
Country [24] 0 0
United Arab Emirates
State/province [24] 0 0
Ras Al Khaimah
Country [25] 0 0
United Arab Emirates
State/province [25] 0 0
Umm Al Quwain

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02453685
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications