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A 38 Week 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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A 38 Week 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

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.

NCT02906917•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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
•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)

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

Locations (71)

Novo Nordisk Investigational Site

Glendale, Arizona, United States

Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Novo Nordisk Investigational Site

Anaheim, California, United States

Novo Nordisk Investigational Site

Concord, California, United States

Novo Nordisk Investigational Site

Fresno, California, United States

Novo Nordisk Investigational Site

La Jolla, California, United States

Novo Nordisk Investigational Site

Northridge, California, United States

Novo Nordisk Investigational Site

Danbury, Connecticut, United States

Novo Nordisk Investigational Site

Fort Lauderdale, Florida, United States

Novo Nordisk Investigational Site

Fort Lauderdale, Florida, United States

Key Dates

Start Date

September 20, 2016

Primary Completion Date

August 31, 2017

Completion Date

December 24, 2017

Last Updated

November 13, 2019

Enrollment

532

ACTUAL participants

Conditions

DiabetesDiabetes Mellitus, Type 2

Interventions

Insulin degludec/insulin aspart

DRUG

Insulin glargine

DRUG

Insulin aspart

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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