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

Phase 4

Completed

• Conditions: Health Condition 1: null- Diabetes Mellitus, Type 2Health Condition 2: E11- Type 2 diabetes mellitus

• Registration Number: CTRI/2015/08/006139
• Lead Sponsor: ovo Nordisk AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-09-21
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 61

Inclusion Criteria

18 Years and older

-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: â?? Metformin (equal or above

1000 mg or maximum tolerated dose documented in the patient medical record) and â?? Sulfonylurea â??

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 â??main mealâ?? will be according to the investigatorâ??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

Study & Design

• Study Type: Interventional
• Study Design: Not specified