NCT02906917|CompletedPhase 3ResultsFDA Drug

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.

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN5401-42662015-004768-12U1111-1175-7895

Study Type

interventional

Target

532

Locations

7 countries

Sites

Timeline

RegisteredSep 2016

StartedSep 2016

CompletionDec 2017

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

532

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Sep 2016

Geographic Reach

7 countries

71 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

September 15, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed

Same day until next milestone

Study Start

First participant enrolled

September 20, 2016

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2017

Completed

9 months until next milestone

Results Posted

Study results publicly available

September 28, 2018

Completed

Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

12 months

First QC Date

September 15, 2016

Results QC Date

August 28, 2018

Last Update Submit

November 8, 2019

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (11)

Change in HbA1c (%) - Week 38
Week 0, week 38
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
+6 more secondary outcomes

Study Arms (2)

IDegAsp

EXPERIMENTAL

Drug: Insulin degludec/insulin aspart

IGlar + IAsp

ACTIVE COMPARATOR

Drug: Insulin glargineDrug: Insulin aspart

Interventions

Insulin degludec/insulin aspartDRUG

Administered subcutaneously (s.c. under the skin) once daily.

IDegAsp

Insulin glargineDRUG

Administered subcutaneously (s.c. under the skin) once daily.

IGlar + IAsp

Insulin aspartDRUG

Administered subcutaneously (s.c. under the skin) once daily.

IGlar + IAsp

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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
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)

Contact the study team to confirm eligibility.