A trial comparing 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

Phase 1

Conditions: Diabetes Mellitus, Type 2
MedDRA version: 17.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2014-003708-62-BG

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 336

Inclusion Criteria

1. 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.
2. Male or female, age = 18 years at the time of signing informed consent.
3. Type 2 diabetes subjects clinically diagnosed = 6 months prior to screening.
4. Treatment with stable daily dose (for at least 90 days prior to screening) of:
– Metformin (=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, SGLT2, colesevelam, bromocriptin and/or combination products at randomisation.
5. Insulin-naïve. Short term insulin treatment for acute illnesses for a total of = 14 days is allowed as is prior insulin treatment for gestational diabetes.
6. HbA1c 7.0-9.5 % (both inclusive) analysed by central laboratory.
7. 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 302
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

1. 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).
2. Impaired liver function, defined as ALT = 2.5 times upper limit of normal (central laboratory value measured at screening visit).
3. Inadequately treated high blood pressure defined as Class 2 hypertension or higher (i.e. systolic blood pressure = 160 mm Hg or diastolic = 100 mm Hg) in accordance with the National High Blood Pressure Education Program, 7th Joint National Committee and ESH/ESC 2013 Guidelines
4. 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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effect of intensification with BIAsp 30 versus intensification with basal bolus insulin analogues (insulin glargine and insulin aspart) on glycaemic control.;Secondary Objective: 1. To compare safety and tolerability between the BIAsp arm and the Basal-bolus arm.<br>2. To compare the total daily insulin dose between the BIAsp arm and the Basal-bolus arm.;Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: After 32 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. HbA1c < 7.0% without severe hypoglycaemic episodes (yes/no).<br>2. Number of treatment emergent hypoglycaemic episodes classified according to the ADA and the Novo Nordisk definitions.<br>3. Total daily insulin dose.;Timepoint(s) of evaluation of this end point: 1. After 32 weeks of treatment <br>2. + 3. During 32 weeks of treatment