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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

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ClinicalTrials.gov Identifier: NCT02453685
Recruitment Status : Completed
First Posted : May 25, 2015
Results First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30 Drug: insulin glargine Drug: insulin aspart Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 335 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 31, 2015
Actual Primary Completion Date : September 20, 2016
Actual Study Completion Date : September 20, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BIAsp Drug: 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.
Active Comparator: IGlar + IAsp Drug: 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.

Drug: insulin aspart
Injected s.c./subcutaneously once daily.


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 32 ]
    Change in HbA1c from baseline (week 0) to week 32.


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

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

  3. Total Daily Insulin Dose [ Time Frame: Weeks 0-32 ]
    Total daily insulin dose in the basal bolus treatment group and in BIAsp 30 treatment group at each week of each treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453685


Locations
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Australia, New South Wales
Novo Nordisk Investigational Site
Broadmeadow, New South Wales, Australia, 2292
Novo Nordisk Investigational Site
Coffs Harbour, New South Wales, Australia, 2450
Australia, Queensland
Novo Nordisk Investigational Site
Ipswich, Queensland, Australia, 4305
Australia, Victoria
Novo Nordisk Investigational Site
Fitzroy, Victoria, Australia, 3065
Novo Nordisk Investigational Site
Melbourne, Victoria, Australia, 3004
Bulgaria
Novo Nordisk Investigational Site
Petrich, Bulgaria, 2850
Novo Nordisk Investigational Site
Sliven, Bulgaria, 8800
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1202
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1431
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1606
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1032
Novo Nordisk Investigational Site
Budapest, Hungary, 1042
Novo Nordisk Investigational Site
Nyíregyhaza, Hungary, 4400
India
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India, 500003
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, 560060
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400008
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400058
Novo Nordisk Investigational Site
Madurai, Tamil Nadu, India, 625 020
Novo Nordisk Investigational Site
Vellore, Tamil Nadu, India, 632004
Novo Nordisk Investigational Site
Kolkata, West Bengal, India, 700032
Novo Nordisk Investigational Site
New Delhi, India, 110001
Korea, Republic of
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 02447
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 03722
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 135710
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 138-736
Serbia
Novo Nordisk Investigational Site
Belgrade, Serbia, 11000
Novo Nordisk Investigational Site
Belgrade, Serbia, 11080
Novo Nordisk Investigational Site
Nis, Serbia, 18000
Thailand
Novo Nordisk Investigational Site
Bangkoknoi, Bangkok, Thailand, 10700
Novo Nordisk Investigational Site
Bangkok, Thailand, 10330
Novo Nordisk Investigational Site
Bangkok, Thailand, 10400
Novo Nordisk Investigational Site
Khon Kaen, Thailand, 40002
Turkey
Novo Nordisk Investigational Site
Antalya, Turkey, 07058
Novo Nordisk Investigational Site
Istanbul, Turkey, 34303
Novo Nordisk Investigational Site
Istanbul, Turkey, 34752
Novo Nordisk Investigational Site
Malatya, Turkey, 44280
Novo Nordisk Investigational Site
Rize, Turkey, 53020
United Arab Emirates
Novo Nordisk Investigational Site
Ajman, United Arab Emirates, 21499
Novo Nordisk Investigational Site
Dubai, United Arab Emirates, 22241
Novo Nordisk Investigational Site
Ras Al Khaimah, United Arab Emirates, 4727
Novo Nordisk Investigational Site
Umm Al Quwain, United Arab Emirates, 24
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02453685    
Other Study ID Numbers: BIASP-4157
2014-003708-62 ( EudraCT Number )
U1111-1158-7280 ( Other Identifier: WHO )
First Posted: May 25, 2015    Key Record Dates
Results First Posted: February 8, 2019
Last Update Posted: February 8, 2019
Last Verified: September 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
 Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Hypoglycemic Agents
Physiological Effects of Drugs