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

NCT ID: NCT02906917

Last Updated: 2019-11-13

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

532 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-20

Study Completion Date

2017-12-24

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IDegAsp

Group Type EXPERIMENTAL

Insulin degludec/insulin aspart

Intervention Type DRUG

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

IGlar + IAsp

Group Type ACTIVE_COMPARATOR

Insulin glargine

Intervention Type DRUG

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

Insulin aspart

Intervention Type DRUG

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

Interventions

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Insulin degludec/insulin aspart

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

Intervention Type DRUG

Insulin glargine

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

Intervention Type DRUG

Insulin aspart

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Anaheim, California, United States

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Concord, California, United States

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Fresno, California, United States

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La Jolla, California, United States

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Northridge, California, United States

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Danbury, Connecticut, United States

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Fort Lauderdale, Florida, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Roswell, Georgia, United States

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Louisville, Kentucky, United States

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Chesterfield, Missouri, United States

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New York, New York, United States

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Westfield, New York, United States

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Wilmington, North Carolina, United States

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Franklin, Ohio, United States

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Bartlett, Tennessee, United States

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Chattanooga, Tennessee, United States

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Kingsport, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Chesapeake, Virginia, United States

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Midlothian, Virginia, United States

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Winchester, Virginia, United States

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Constantine, , Algeria

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Oran, , Algeria

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Sidi Bel Abbes, , Algeria

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Broumov, , Czechia

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Náchod, , Czechia

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Náchod, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Trutnov, , Czechia

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Hyderabad, Andhra Pradesh, India

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Hyderabad, Andhra Pradesh, India

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Surat, Gujarat, India

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Kozhikode, Kerala, India

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Aurangabad, Maharashtra, India

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Mumbai, Maharashtra, India

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New Dehli, New Delhi, India

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Coimbatore, Tamil Nadu, India

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Kolkata, West Bengal, India

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New Delhi, , India

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Arkhangelsk, , Russia

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Cheboksary, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Saratov, , Russia

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Syktyvkar, , Russia

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Tyumen, , Russia

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Belgrade, , Serbia

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Belgrade, , Serbia

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Niš, , Serbia

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Adana, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Countries

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United States Algeria Czechia India Russia Serbia Turkey (Türkiye)

References

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Philis-Tsimikas A, Astamirova K, Gupta Y, Haggag A, Roula D, Bak BA, Fita EG, Nielsen AM, Demir T. Similar glycaemic control with less nocturnal hypoglycaemia in a 38-week trial comparing the IDegAsp co-formulation with insulin glargine U100 and insulin aspart in basal insulin-treated subjects with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2019 Jan;147:157-165. doi: 10.1016/j.diabres.2018.10.024. Epub 2018 Nov 16.

Reference Type RESULT
PMID: 30448451 (View on PubMed)

Yang W, Akhtar S, Franek E, Haluzik M, Hirose T, Kalyanam B, Kar S, Wu T, Gogas Yavuz D, Unnikrishnan AG. Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp. Diabetes Ther. 2022 Feb;13(2):311-323. doi: 10.1007/s13300-021-01196-7. Epub 2022 Jan 19.

Reference Type DERIVED
PMID: 35044568 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2015-004768-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1175-7895

Identifier Type: OTHER

Identifier Source: secondary_id

NN5401-4266

Identifier Type: -

Identifier Source: org_study_id

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