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
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 30 (Drug); insulin glargine (Drug); insulin aspart (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s): Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S
Overall contact: Novo Nordisk, Email: clinicaltrials@novonordisk.com
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in HbA1c (glycosylated haemoglobin)
Secondary outcome: HbA1c below 7.0% without severe hypoglycaemic episodesNumber of treatment emergent hypoglycaemic episodes classified according to the ADA and the Novo Nordisk definitions Total daily insulin dose
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Novo Nordisk, Email: clinicaltrials@novonordisk.com
Petrich 2850, Bulgaria; Not yet recruiting
Budapest 1042, Hungary; Not yet recruiting
New Delhi 110001, India; Not yet recruiting
Seoul 138-736, Korea, Republic of; Not yet recruiting
Belgrade 11080, Serbia; Not yet recruiting
Bangkok 10330, Thailand; Not yet recruiting
Istanbul 34752, Turkey; Not yet recruiting
Ras Al Khaimah 4727, United Arab Emirates; Not yet recruiting
Coffs Harbour, New South Wales 2450, Australia; Not yet recruiting
Additional Information
Clinical Trials at Novo Nordisk
Starting date: September 2015
Last updated: July 8, 2015
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