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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

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 episodes

Number 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

Page last updated: August 23, 2015

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