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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02453685
• Date of registration: 21/05/2015
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• 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
• Date of first enrolment: August 31, 2015
• Target sample size: 335
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02453685
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Australia, Bulgaria, Hungary, India, Korea, Republic of, Serbia, Thailand, Turkey, United Arab Emirates

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes

Diabetes Mellitus, Type 2

Intervention(s)

Drug: insulin glargine

Drug: insulin aspart

Drug: biphasic insulin aspart 30

Primary Outcome(s)

Change in HbA1c (Glycosylated Haemoglobin) [Time Frame: Week 0, week 32]

Secondary Outcome(s)

HbA1c Below 7.0% Without Severe Hypoglycaemic Episodes [Time Frame: After 32 weeks of treatment (yes/no)]

Total Daily Insulin Dose [Time Frame: Weeks 0-32]

Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) and the Novo Nordisk Definitions [Time Frame: Weeks 0-32]

Secondary ID(s)

BIASP-4157

U1111-1158-7280

2014-003708-62

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/02/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02453685