This Trial is Conducted Globally. The Aim of This Trial is to Compare the 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 Intensification.

Novo Nordisk A/S1 site in 1 country532 target enrollmentSeptember 20, 2016

ConditionsDiabetes Diabetes Mellitus, Type 2

InterventionsInsulin degludec/insulin aspart Insulin glargine Insulin aspart

DrugsInsulin degludec/insulin aspart Insulin glargine Insulin aspart

Overview

Phase: Phase 3
Intervention: Insulin degludec/insulin aspart
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 532
Locations: 1
Primary Endpoint: Change in HbA1c (%) - Week 26
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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 intensification.

Registry

clinicaltrials.gov

Start Date

September 20, 2016

End Date

December 24, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility 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 Algeria: Male or female, age at least 19 years at the time of signing informed consent
•Diagnosed with type 2 diabetes mellitus
•Treated with any basal insulin for at least 90 days prior to the day of screening
•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 at least 1500 mg or maximum tolerated dose documented in the subject medical record) b. Other OADs (at least 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. α-glucosidase inhibitors iv. Sodium/glucose co-transporter 2 (SGLT-2) inhibitors v. Oral combination products (of the allowed individual OADs above)
•HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) by central laboratory analysis
•Body mass index (BMI) equal to or below 45.0 kg/m\^2

Exclusion Criteria

•Participation in any clinical trial of an approved or non-approved investigational medicinal product within four weeks prior to the day of screening (V1)
•Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
•Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) equal or below 90 days prior to the day of the screening and between screening and randomisation
•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
•Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 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
•Impaired liver function, defined as alanine aminotransferase (ALT) equal to or above 2.5 times upper normal limit (UNL) at screening.
•Subjects presently classified as being in New York Heart Association (NYHA) Class IV
•Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
•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
•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)

Arms & Interventions

IDegAsp

Intervention: Insulin degludec/insulin aspart

IGlar + IAsp

Intervention: Insulin glargine

IGlar + IAsp

Intervention: Insulin aspart

Outcomes

Primary Outcomes

Change in HbA1c (%) - Week 26

Time Frame: Week 0, week 26

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated 26 weeks after randomisation.

Secondary Outcomes

Responder (Yes/No) for HbA1c < 7%(Week 26 and week 38)
Responder (Yes/No) for HbA1c <7% Without Severe or BG Confirmed Symptomatic Hypoglycaemia(Week 26 and week 38)
Change in FPG(Week 0, week 26, week 38)
Change in Pre-breakfast SMPG (Used for Titration)(Week 1, week 26, week 38)
Change in Postprandial SMPG Increment (From 9-point Profile)(Week 0, week 26, week 38)
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-26, weeks 16-26, weeks 0-38)
Change in HbA1c (%) - Week 38(Week 0, week 38)
Total Insulin Dose(Week 26 and week 38)
Incidence of TEAEs(Weeks 0-26, weeks 26-38, weeks 0-38)
Number of Nocturnal, Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-26, weeks 16-26, weeks 0-38)
Change in Body Weight(Week 0, week 26, week 38)