Clinical trial NCT04460885: A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before
Official title: A 78-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Treatment, in Insulin naïve Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-07-08
Enrollment: 984
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an insulin taken once daily which is already available on the market) in people with type 2 diabetes.

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

The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 1 ½ years. Participants will have 37 clinic visits and 26 phone calls with the study doctor. At 11 clinic visits participant will have blood samples taken. At 8 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.

Participants will be asked to wear a sensor that measures the blood sugar all the time in 5 periods of about one month during the study (about 5 months in total). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility criteria: Inclusion Criteria:

* Male or female aged above or equal to 18 years at the time of signing informed consent.
* Diagnosed with type 2 diabetes mellitus (T2D) 180 days or more prior to the day of screening.
* HbA1c from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
* 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) 90 days or more prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s): a. Any metformin formulations at least or greater than 1500 mg or maximum tolerated or effective dose. b. Any metformin combination formulations equal to or above 1500 mg or maximum tolerated or effective dose. c. Any of the following oral anti-diabetic drug classes including combinations ((equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose): Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral anti-diabetic drugs), Oral or injectable glucagon-like peptide 1 (GLP-1) receptor agonists
* Body mass index (BMI) equal to or below 40.0 kg/m\^2.

Exclusion Criteria:

* Any episodes (as declared by the subject or in the medical records) of diabetic ketoacidosis within 90 days prior to the day of screening.
* Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
* Chronic heart failure classified as being in New York Heart Association Class IV at 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).
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Primary outcomes:
measure: Change in Glycated Haemoglobin (HbA1c)
timeFrame: Baseline (week 0), Week 52
Secondary outcomes:
measure: Percentage of Time in Target Range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System
timeFrame: From week 48 to week 52
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Baseline (week 0), Week 52
measure: Number of Severe Hypoglycaemic Episodes (Level 3) Until Week 52
timeFrame: From baseline (week 0) to week 52
measure: Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than [<] 3.0 mmol/L [54 mg/dL] Confirmed by Blood Glucose [BG] Meter) Until Week 52
timeFrame: From baseline (week 0) to week 52
measure: Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3) Until Week 52
timeFrame: From baseline (week 0) to week 52
measure: Number of Severe Hypoglycaemic Episodes (Level 3) Until Week 83
timeFrame: From baseline (week 0) to week 83
measure: Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL) Confirmed by BG Meter) Until Week 83
timeFrame: From baseline (week 0) to week 83
measure: Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3) Until Week 83
timeFrame: From baseline (week 0) to week 83
measure: Mean Weekly Insulin Dose
timeFrame: From week 50 to week 52
measure: Change in Body Weight
timeFrame: Baseline (week 0), Week 52
measure: Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System
timeFrame: From week 48 to week 52
measure: Percentage of Time Spent > 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System
timeFrame: From week 48 to week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Uni of Alabama at 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: Lancaster
country: United States
facility: First Valley Medical Group
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Hlthcr Med Group
state: California
city: Ventura
country: United States
facility: Coastal Metabolic Research Center
state: California
city: Waterbury
country: United States
facility: Chase Medical Research LLC
state: Connecticut
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
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: West Palm Beach
country: United States
facility: Metabolic Research Institute Inc
state: Florida
city: Honolulu
country: United States
facility: East West Medical Research Institute_Honolulu
state: Hawaii
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Gurnee
country: United States
facility: Clinical Invest Special_Gurnee
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Diab & Endo Res Center
state: Iowa
city: Topeka
country: United States
facility: Cotton-O'Neil Diab & Endo Ctr
state: Kansas
city: Paducah
country: United States
facility: Four Rivers Clinical Research Inc
state: Kentucky
city: Hyattsville
country: United States
facility: MedStar Hlth Res Institute
state: Maryland
city: Rockville
country: United States
facility: Endo And Metab Cons
state: Maryland
city: Troy
country: United States
facility: Arcturus Healthcare, PLC.
state: Michigan
city: Omaha
country: United States
facility: Univ of Nebraska Medical CTR
state: Nebraska
city: Albuquerque
country: United States
facility: Albuquerque Clin Trials, Inc.
state: New Mexico
city: Brooklyn
country: United States
facility: N.Y. Total Medical Care 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
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: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Norman
country: United States
facility: Intend Research
state: Oklahoma
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: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Austin
country: United States
facility: Texas Diab & Endo, P.A.
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_Houston
state: Texas
city: Lampasas
country: United States
facility: Fmc Science, Llc
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: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Newport News
country: United States
facility: TPMG Clinical Research
state: Virginia
city: Renton
country: United States
facility: Rainier Clin Res Ctr Inc
state: Washington
city: Osijek
country: Croatia
facility: Poliklinika SLAVONIJA OSIJEK
state: Osječko - Baranjska Županija
city: Karlovac
country: Croatia
facility: Opca bolnica Karlovac
city: Rijeka
country: Croatia
facility: KBC Rijeka, Endokrinologija
city: Varazdin
country: Croatia
facility: Opca bolnica Varazdin
city: Rohtak
country: India
facility: PGIMS Rohtak
state: Haryana
city: Indore
country: India
facility: TOTALL Diabetes Hormone Institute
state: Madhya Pradesh
city: Mumbai
country: India
facility: BYL Nair Hospital and T N Medical College Department of endo
state: Maharashtra
city: Pune
country: India
facility: chelleram Diabetes Institute
state: Maharashtra
city: Chennai
country: India
facility: Madras Diabetes Research Foundation
state: Tamil Nadu
city: Vellore
country: India
facility: Christian Medical College Hospital, Vellore
state: Tamil Nadu
city: Hyderabad
country: India
facility: Osmania General Hospital
state: Telangana
city: Hyderabad
country: India
facility: Ramdev Rao Hospital
state: Telangana
city: Hyderabad
country: India
facility: Gandhi Hospital & Medical college
state: Telengana
city: Holon
country: Israel
facility: Diabetes Clinic Wolfson MC
city: Jerusalem
country: Israel
facility: Diabetes Unit Hadassah Ein Karem MC
city: Kfar Saba
country: Israel
facility: Diabetes Clinic Meir MC
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Rehovot
country: Israel
facility: Kaplan MC
city: Roma
country: Italy
facility: Policlinico Umberto I Seconda Clinica Medica
state: RM
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Catanzaro
country: Italy
facility: Policlinico Mater Domini Università di Catanzaro
city: Milano
country: Italy
facility: Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia
city: Palermo
country: Italy
facility: Policlinico Universitario Paolo Giaccone
city: Chigasaki-shi, Kanagawa
country: Japan
facility: Hayashi Diabetes Clinic
state: Kanagawa, Japan
city: Chigasaki-shi
country: Japan
facility: Hayashi Diabetes Clinic
state: Kanagawa, Japan
city: Miyazaki-shi
country: Japan
facility: Heiwadai Hospital
state: Miyazaki
city: Bunkyo-ku, Tokyo
country: Japan
facility: The University of Tokyo Hospital, Diabetes and Metabolic
city: Chiba
country: Japan
facility: Tokuyama clinic
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Futata Tetsuhiro Clinic Meinohama
city: Ibaraki
country: Japan
facility: Naka Kinen Clinic
city: Kitakyusyu-shi, Fukuoka
country: Japan
facility: Sugimoto Clinic,Internal Medicine
city: Minato-ku, Tokyo
country: Japan
facility: Toranomon Hospital, Endocrinology and Metabolism
city: Miyagi
country: Japan
facility: Shinden Higashi Clinic_Miyagi
city: Osaka
country: Japan
facility: Takatsuki Red Cross Hospital
city: Saitama
country: Japan
facility: Shimizu Clinic Fusa
city: Shimotsuke-shi, Tochigi
country: Japan
facility: Wakakusa Clinic
city: Tochigi
country: Japan
facility: Oyama East Clinic
city: Ushiku-shi, Ibaraki
country: Japan
facility: Noritake Clinic
city: Guadalajara
country: Mexico
facility: InstitutoJalisciense de Investigación en Diabetes y Obesidad
state: Jalisco
city: Mexico City
country: Mexico
facility: Clínica Omega Diabetes, S.C.
state: México, D.F.
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. José Eleuterio González
state: Nuevo León
city: Hermosillo
country: Mexico
facility: Investigación Médica Sonora S.C.
state: Sonora
city: Lublin
country: Poland
facility: NZOZ "CenterMed Lublin" Sp. z o.o.
state: Lubelskie
city: Lublin
country: Poland
facility: NZOZ Przychodnia Specjalistyczna Medica
state: Lubelski
city: Gorzow Wielkopolski
country: Poland
facility: Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
state: Lubuskie
city: Warsaw
country: Poland
facility: NBR Polska Tomasz Klodawski
state: Mazowieckie
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
state: Podlaskie
city: Radom
country: Poland
facility: Centrum Medyczne "Diabetika"
city: Wierzchoslawice
country: Poland
facility: Centrum Zdrowia Tuchow Sp z o.o.
city: Zabrze
country: Poland
facility: Prywatny Gabinet Janusz Gumprecht
city: Bayamon
country: Puerto Rico
facility: Advanced Clinical Research LLC
city: Manati
country: Puerto Rico
facility: Manati Ctr For Clin Research
city: Kemerovo
country: Russian Federation
facility: SAHI Kuzbass Hospital(former Regional clinical hospital)
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Endocrinology
city: Moscow
country: Russian Federation
facility: Setchenov First Moscow State Medical University
city: Novosibirsk
country: Russian Federation
facility: Limited Law Company "Healthy Family" Medicine Center"
city: Novosibirsk
country: Russian Federation
facility: Scientifc Institute of Clinical and Experimental Lymphology
city: Penza
country: Russian Federation
facility: Penza Regional Clinical Hospital named after N.N. Burdenko
city: Saint Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
city: Saint-Petersburg
country: Russian Federation
facility: Limited Liability Company "Energiya Zdoroviya"
city: Saint-Petersburg
country: Russian Federation
facility: Medinet LLC
city: Saint-Petersburg
country: Russian Federation
facility: Consultative & Diagnostic Center with a Outpatient Hospital
city: Saratov
country: Russian Federation
facility: Regional clinical cardiology dispensary
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Consultive-diagnostic Centre
city: Yoshkar-Ola
country: Russian Federation
facility: Polyclinic #2 in Yoshkar-Ola
city: Sahy
country: Slovakia
facility: Peter Farkas MD, s.r.o.
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: Diacrin s. r. o.
city: Bratislava
country: Slovakia
facility: MEDISPEKTRUM s.r.o.
city: Malacky
country: Slovakia
facility: MediVet s.r.o.
city: Malacky
country: Slovakia
facility: SIN AZUCAR s.r.o.
city: Moldava nad Bodvou
country: Slovakia
facility: Diabetologicka ambulancia SchronerMED, s.r.o.
city: Trebisov
country: Slovakia
facility: ARETEUS s.r.o.
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: La Roca del Vallés
country: Spain
facility: ABS La Roca del Vallés
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Centro de Especialidades José Marva
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quirón
city: Bollington
country: United Kingdom
facility: Bollington Medical Centre
state: Cheshire
city: Blackpool
country: United Kingdom
facility: Layton Medical Centre
city: Bradford-on-Avon
country: United Kingdom
facility: The Health Centre
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital_Cambridge
city: Dorset
country: United Kingdom
facility: The Adam Practice
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Hinckley
country: United Kingdom
facility: Burbage Surgery
city: Soham
country: United Kingdom
facility: The Staploe Medical Centre
city: Swansea
country: United Kingdom
facility: Joint Clinical Research Facility - Swansea
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital (Treliske)
city: Wellingborough
country: United Kingdom
facility: Albany House Medical Centre
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (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.