A trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or without oral antidiabetic treatment in need of treatment intensificatio

Phase 1

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 19.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-004768-12-CZ
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-25
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 528

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. Algeria: Male or female, age = 19 years at the time of signing informed consent
3. Diagnosed with type 2 diabetes mellitus
4. Treated with any basal insulin = 90 days prior to the day of screening
5. Subject not on any OAD(s) prior to trial participation OR subjects on stable daily dose(s) of OAD(s) for at least 90 days prior to screening visit (V1). The OAD(s) include any of the following anti-diabetic drug(s)/regimen:
a. Biguanides (metformin = 1500 mg or maximum tolerated dose documented in the subject medical record)
b. Other OADs (= half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record):
i. Insulin secretagogues (SU and glinides)
ii. Di-peptidyl-peptidase IV (DPP-4) inhibitors
iii. a-glucosidase inhibitors
iv. Sodium/glucose co-transporter 2 (SGLT-2) inhibitors
v. Oral combination products (of the allowed individual OADs above)
6. HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) by central laboratory analysis
7. Body mass index (BMI) = 45.0 kg/m^2

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 396
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 132

Exclusion Criteria

1. Participation in any clinical trial of an approved or non-approved investigational medicinal product within four weeks prior to the day of screening (V1)
2. Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject’s safety or compliance with the protocol
3. Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) = 90 days prior to the day of the screening and between screening and randomisation
4. Any of the following: myocardial infarction , stroke or hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and between screening and randomisation
5. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening
6. Impaired liver function, defined as alanine aminotransferase (ALT) = 2.5 times upper normal limit (UNL) at screening.
7. Subjects presently classified as being in New York Heart Association (NYHA) Class IV
8. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
9. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening.
10. Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified