Clinical trial NCT04760626: A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before
Official title: Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-02-18
Enrollment: 1085
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares insulin icodec to different daily insulins in people with type 2 diabetes.

The study will look at how well insulin icodec taken once weekly controls blood sugar compared to the insulins taken once daily. Participants will either get insulin icodec, that participants will have to inject once a week on the same day of the week, or a marketed insulin, that participants will have to inject once a day. Which treatment participants get is decided at random.

The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.

Participants will measure their blood sugar every day. Participants will get a study phone to record safety data in the electronic diary (eDiary). If participants get a daily insulin they will record their insulin doses in the eDiary. If Participants get weekly insulin icodec, participants study phone will also have the DoseGuide App. The DoseGuide App gives dose recommendations based on their blood sugar and previous doses. Participants will record their insulin doses in the DoseGuide App.

The study will last for about 1 year and 2 months. Participants will have 8 planned clinic visits with the study doctor. More visits will be planned to meet individual needs. At 6 clinic visits participants will have blood samples taken.

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


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 above or equal to 18 years at the time of signing informed consent.
* Diagnosed with T2D greater than or equal to 180 days prior to the day of screening.
* HbA1c above 7.0% (53 mmol/mol) as measured by central lab.
* Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
* Stable daily dose(s) greater than or equal to 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regimen(s): a .Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. b .Any metformin combination formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. c. Any of the following non-insulin antidiabetic drug classes including combinations (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose):i). Sulfonylureas ii). Meglitinides (glinides) iii). DPP-4 inhibitors iv. SGLT2 inhibitors v). Thiazolidinediones vi). Alpha-glucosidase inhibitors vii). Oral combination products (for the allowed individual Oral Antidiabetic Drugs (OADs)) viii). Oral or injectable GLP-1-receptor agonists.
* Intensification with insulin is indicated to achieve glycaemic target (4.4-7.2 mmol/L, 80-130 mg/dL) at the discretion of the treating investigator.

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products.
* Previous participation in this trial. Participation is defined as signed informed consent.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
* Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening)
* Any disorder which in the investigator's opinion might jeopardise subject's safety.

Primary outcomes:
measure: Change in HbA1c (glycated haemoglobin)
timeFrame: From baseline week 0 (V2) to week 52 (V6)
Secondary outcomes:
measure: Time from baseline to treatment discontinuation or intensification
timeFrame: From baseline week 0 (V2) to week 52 (V6)
measure: Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction
timeFrame: From baseline week 0 (V2) to week 52 (V6)
measure: Trim-D (Treatment Related Impact Measure for Diabetes) compliance domain
timeFrame: At end of treatment week 52 (V6)
measure: Number of severe hypoglycaemic episodes (level 3)
timeFrame: From baseline week 0 (V2) to week 57 (V8)
measure: Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
timeFrame: From baseline week 0 (V2) to week 57 (V8)
measure: Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
timeFrame: From baseline week 0 (V2) to week 57 (V8)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama Birmingham
state: Alabama
city: Guntersville
country: United States
facility: Lakeview Clinical Research, LLC
state: Alabama
city: Buena Park
country: United States
facility: American Clinical Trials
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Hawthorne
country: United States
facility: Advanced Investigative Medicine, Inc.
state: California
city: Huntington Beach
country: United States
facility: Diabetes/Lipid Mgmt & Res Ctr
state: California
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Inst
state: California
city: Lancaster
country: United States
facility: First Valley Medical Group
state: California
city: Lomita
country: United States
facility: Torrance Clin Res Inst, Inc.
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Hlthcr Med Group
state: California
city: Sacramento
country: United States
facility: Clinical Trials Research_Sacramento
state: California
city: San Diego
country: United States
facility: San Diego Family Care
state: California
city: San Ramon
country: United States
facility: NorCal Endocrinology and Internal Medicine
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research_Spring Valley
state: California
city: Ventura
country: United States
facility: Coastal Metabolic Research Center
state: California
city: West Hills
country: United States
facility: San Fernando Valley Hlth Inst
state: California
city: Jacksonville
country: United States
facility: Est Cst Inst for Rsrch,Jksnvil
state: Florida
city: Mount Dora
country: United States
facility: Adult Medicine of Lake County, Inc.
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clin Res Port Richey
state: Florida
city: Orlando
country: United States
facility: Florida Inst For Clin Res
state: Florida
city: Palm Harbor
country: United States
facility: Palm Harbor Medical Associates
state: Florida
city: Palm Harbor
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute Inc
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida_Winter Haven
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Roswell
country: United States
facility: Endo Res Solutions, Inc
state: Georgia
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Springfield
country: United States
facility: Central Illinois Diabetes and Clinical Research
state: Illinois
city: Topeka
country: United States
facility: Cotton O'Neil Clin Research Ctr
state: Kansas
city: Hyattsville
country: United States
facility: MedStar Community Clin Res Ctr
state: Maryland
city: Rockville
country: United States
facility: Endo and Metab Consultants
state: Maryland
city: Buckley
country: United States
facility: Northern Pines Hlth Ctr, PC
state: Michigan
city: Troy
country: United States
facility: Arcturus Healthcare, PLC.
state: Michigan
city: Jefferson City
country: United States
facility: Jefferson City Medical Group, PC
state: Missouri
city: Omaha
country: United States
facility: Methodist Physicians Clin
state: Nebraska
city: Omaha
country: United States
facility: Univ of Nebraska Medical CTR
state: Nebraska
city: Las Vegas
country: United States
facility: Palm Research Center Inc-Vegas
state: Nevada
city: Nashua
country: United States
facility: Southern New Hampshire Diabetes and Endocrinology
state: New Hampshire
city: Albuquerque
country: United States
facility: Albuquerque Clin Trials, Inc.
state: New Mexico
city: Albany
country: United States
facility: Albany Medical College - Endo
state: New York
city: Brooklyn
country: United States
facility: N.Y. Total Medical Care PC
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research, PLLC
state: New York
city: Smithtown
country: United States
facility: Endocrine Associates of Long Island, PC
state: New York
city: West Seneca
country: United States
facility: Southgate Medical Group, LLP
state: New York
city: Greenville
country: United States
facility: Physicians East Endocrinology
state: North Carolina
city: Raleigh
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Fargo
country: United States
facility: Plains Clinical Research Center, LLC_Fargo
state: North Dakota
city: Canton
country: United States
facility: Diab & Endo Assoc of Stark Co
state: Ohio
city: Dayton
country: United States
facility: Providence Health Partners Ctr
state: Ohio
city: Wadsworth
country: United States
facility: New Venture Medical Research
state: Ohio
city: Murrells Inlet
country: United States
facility: The Diabetes Center, LLC
state: South Carolina
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research
state: South Carolina
city: Bartlett
country: United States
facility: AM Diabetes And Endocrinology Center
state: Tennessee
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
city: Chattanooga
country: United States
facility: Univ Diab & Endo Consultants
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Morristown
country: United States
facility: HealthStar Physicians PC
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Med Spec LLP
state: Texas
city: Austin
country: United States
facility: Texas Diab & Endo, P.A.
state: Texas
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Med Cntr
state: Texas
city: Houston
country: United States
facility: PrimeCare Medical Group
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research
state: Texas
city: Katy
country: United States
facility: Medical Colleagues-Texas LLP
state: Texas
city: Lampasas
country: United States
facility: Fmc Science, Llc
state: Texas
city: Laredo
country: United States
facility: Andres Garcia-Zuniga, MD, P.A
state: Texas
city: Round Rock
country: United States
facility: Texas Diab & Endo, P.A.
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
city: San Antonio
country: United States
facility: NE Clin Res of San Antonio
state: Texas
city: Sugar Land
country: United States
facility: Simcare Medical Research, LLC
state: Texas
city: Bountiful
country: United States
facility: Wade Family Medicine
state: Utah
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Newport News
country: United States
facility: TPMG Clinical Research
state: Virginia
city: Kenosha
country: United States
facility: Clinical Inv Spec, Inc.Kenosha
state: Wisconsin
city: Calgary
country: Canada
facility: LMC Clin Res Inc. Calgary
state: Alberta
city: Red Deer
country: Canada
facility: The Bailey Clinic
state: Alberta
city: Victoria
country: Canada
facility: Dr. M.B. Jones Inc
state: British Columbia
city: Winnipeg
country: Canada
facility: Rivergrove Medical Clinic
state: Manitoba
city: Winnipeg
country: Canada
facility: Winnipeg Clinic
state: Manitoba
city: Moncton
country: Canada
facility: G.A. Research Associates Ltd.
state: New Brunswick
city: Mount Pearl
country: Canada
facility: Commonwealth Medical Clinic
state: Newfoundland and Labrador
city: St. Johns
country: Canada
facility: Eastern Health Authority
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: LMC Diabetes & Endocrinology (Barrie)
state: Ontario
city: Brampton
country: Canada
facility: Centricity Research LMC
state: Ontario
city: Concord
country: Canada
facility: LMC (Thornhill)
state: Ontario
city: Courtice
country: Canada
facility: Medical Trust Clinics, Inc.
state: Ontario
city: Etobicoke
country: Canada
facility: LMC Endo Ctr (Etobicoke) Ltd
state: Ontario
city: Hamilton
country: Canada
facility: Wharton Med Clin Trials
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Med Res Group
state: Ontario
city: London
country: Canada
facility: Milestone Research
state: Ontario
city: London
country: Canada
facility: Western Univ. Cnt for Studies in Fam Med
state: Ontario
city: Nepean
country: Canada
facility: LMC Research Inc. Ottawa
state: Ontario
city: Oakville
country: Canada
facility: LMC Oakville
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clin Res Group,Inc
state: Ontario
city: Stoney Creek
country: Canada
facility: Winterberry Family Medicine
state: Ontario
city: Toronto
country: Canada
facility: LMC Endo Centres Ltd.(Bayview)
state: Ontario
city: Toronto
country: Canada
facility: Dr. Anil K Gupta Medicine Professional Corporation
state: Ontario
city: Brossard
country: Canada
facility: ViaCar Recherche Clinique Inc
state: Quebec
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: Laval
country: Canada
facility: Ctr de rech Clin de Laval
state: Quebec
city: Mirabel
country: Canada
facility: Manna Research Mirabel
state: Quebec
city: Montreal
country: Canada
facility: Applied Med Inf Res
state: Quebec
city: Saint-Charles-Borromee
country: Canada
facility: Diex Recherche Joliette
state: Quebec
city: Saint-Laurent
country: Canada
facility: LMC Clin Rsrch Inc. (Montreal)
state: Quebec
city: St-Marc-des-Carrières
country: Canada
facility: Ctr Méd. et pro d l'Ost d port
state: Quebec
city: Victoriaville
country: Canada
facility: Diex Recherche Victoriaville
state: Quebec
city: Quebec
country: Canada
facility: Recherche Clinique Sigma inc
city: Quebec
country: Canada
facility: Diex Recherche Quebec Inc.
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Bad Mergentheim
country: Germany
facility: Diabetespraxis Mergentheim
city: Berlin
country: Germany
facility: Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
city: Falkensee
country: Germany
facility: Zentrum für klinische Forschung, Dr. med. Lüdemann
city: Hamburg
country: Germany
facility: Wendisch/Dahl Hamburg
city: Hohenmölsen
country: Germany
facility: Milek, Hohenmölsen
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
city: Münster
country: Germany
facility: MedicalCenter am Clemenshospital
city: Oldenburg in Holstein
country: Germany
facility: RED-Institut für medizinische Forschung und Fortbildung GmbH
city: Rehlingen-Siersburg
country: Germany
facility: Praxis Dr. med. Wenzl-Bauer
city: Riesa
country: Germany
facility: Bieler, Riesa
city: Saint Ingbert-Oberwürzbach
country: Germany
facility: Zentrum für klinische Studien Alexander Segner
city: Stuttgart
country: Germany
facility: Erlinger
city: Wangen
country: Germany
facility: Zentrum für klinische Studien Allgäu Oberschwaben
city: Athens
country: Greece
facility: Iatriko Psychicou Private Clinic
city: Athens
country: Greece
facility: 'G. Gennimatas' General Hospital of Athens
city: Athens
country: Greece
facility: Korgiallenio - Benakio Hospital (Red Cross Hosp.)
city: Athens
country: Greece
facility: "Laiko" General Hospital of Athens
city: Athens
country: Greece
facility: Iatriko Athinon 'Palaiou Falirou'
city: Larissa
country: Greece
facility: Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki 'G. Gennimatas
city: Thessaloniki
country: Greece
facility: AHEPA General University Hospital
city: Thessaloniki
country: Greece
facility: "Ippokrateio" G.H. of Thessaloniki
city: Thessaloniki
country: Greece
facility: "Ippokrateio" General Hosp Thessaloniki, A' Internal Med
city: Thessaloniki
country: Greece
facility: EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
city: Thessaloniki
country: Greece
facility: "Thermi" Private Hosital
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G.Papanikolaou"
city: Debrecen
country: Hungary
facility: Belinus Bt.
state: Hajdu-Bihar Varmegye
city: Komárom
country: Hungary
facility: Selye János Kórház és Rendelőintézet
state: Komárom-Esztergom
city: Budapest
country: Hungary
facility: Szent Margit Kórház
city: Budapest
country: Hungary
facility: Óbudai Egészségügyi Centrum
city: Budapest
country: Hungary
facility: Szőcs Depot Egészségügyi Szolgáltató Kft.
city: Budapest
country: Hungary
facility: ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
city: Budapest
country: Hungary
facility: MED-TIMA Kft.
city: Budapest
country: Hungary
facility: MH Egészségügyi Központ
city: Budapest
country: Hungary
facility: Uno Medical Trials Eü. Szolgáltató és Kereskedelmi Kft.
city: Kaposvár
country: Hungary
facility: Kaposi Mór Oktató Kórház
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatókórház
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Kórház
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia
state: Pomorskie
city: Gdansk
country: Poland
facility: NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
city: Lodz
country: Poland
facility: Gabinet Lekarski Malgorzata Saryusz-Wolska
city: Lodz
country: Poland
facility: Pro Salus Centrum Medyczne
city: Lublin
country: Poland
facility: Katedra i Klinika Chorob Wewnetrznych AM w Lublinie
city: Poznan
country: Poland
facility: Oddzial Chorób - Wewn.
city: Pulawy
country: Poland
facility: Velocity Nova Sp. z o.o.
city: Staszow
country: Poland
facility: Velocity Nova Sp. z o.o.
city: Swidnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne Tomasz Blicharski
city: Zabrze
country: Poland
facility: Poradnia dla Chorych na Cukrzycę
city: Manati
country: Puerto Rico
facility: Manati Ctr For Clin Research
city: Adana
country: Turkey
facility: T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
city: Adana
country: Turkey
facility: Baskent Universitesi Adana
city: Ankara
country: Turkey
facility: Ankara Universitesi Ibni Sina Hastanesi
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi Tip Fakultesi Hastanesi
city: Hatay
country: Turkey
facility: Hatay Mustafa Kemal Universitesi Saglik Uygulama ve Arastirm
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi
city: Istanbul
country: Turkey
facility: Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Hastanesi
city: Istanbul
country: Turkey
facility: T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital
city: Istanbul
country: Turkey
facility: Umraniye Egitim ve Arastirma Hastanesi
city: Istanbul
country: Turkey
facility: T.C. S.B. Ist Il SagMud Pendik Egitim ve Arastirma Hastanesi
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References:
citation: Philis-Tsimikas A, Bajaj HS, Begtrup K, Cailleteau R, Gowda A, Lingvay I, Mathieu C, Russell-Jones D, Rosenstock J. Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab. 2023 Feb;25(2):331-341. doi: 10.1111/dom.14871. Epub 2022 Oct 14.