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
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT04460885
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 984
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin icodec Insulin icodec Insulin icodec + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period Insulin glargine Insulin glargine Insulin glargine + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period
- Primary Outcome Measures
Name Time Method Change in HbA1c From baseline week 0 (V2) to week 52 (V46) %-point
- Secondary Outcome Measures
Name Time Method Number of severe hypoglycaemic episodes (level 3) From baseline week 0 (V2) to week 83 (V63) Number of episodes
Change in fasting plasma glucose (FPG) From baseline week 0 (V2) to week 52 (V46) mmol/L
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter) From baseline week 0 (V2) to week 83 (V63) Number of episodes
Time in target range 3.9-10.0 mmol/L (70-180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 From week 48 (V42) to week 52 (V46) % of readings
Mean weekly insulin dose From week 50 (V44) to week 52 (V46) U
Time spent > 10 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 From week 48 (V42) to week 52 (V46) % of readings
Change in body weight From baseline week 0 (V2) to week 52 (V46) kg
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) From baseline week 0 (V2) to week 83 (V63) Number of episodes
Time spent < 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 From week 48 (V42) to week 52 (V46) % of readings
Trial Locations
- Locations (138)
Medinet LLC
🇷🇺Saint-Petersburg, Russian Federation
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Texas Diab & Endo, P.A.
🇺🇸Round Rock, Texas, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Diab & Endo Assoc of Stark Co
🇺🇸Canton, Ohio, United States
Velocity Clinical Res-Dallas
🇺🇸Dallas, Texas, United States
UT Southwestern Med Cntr
🇺🇸Dallas, Texas, United States
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
Intend Research
🇺🇸Norman, Oklahoma, United States
PrimeCare Medical Group
🇺🇸Houston, Texas, United States
Juno Research, LLC_Houston
🇺🇸Houston, Texas, United States
Cotton-O'Neil Diab & Endo Ctr
🇺🇸Topeka, Kansas, United States
Plains Clinical Research Center, LLC
🇺🇸Fargo, North Dakota, United States
Madras Diabetes Research Foundation
🇮🇳Chennai, Tamil Nadu, India
Uni of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Shimizu Clinic Fusa
🇯🇵Saitama, Japan
Ramdev Rao Hospital
🇮🇳Hyderabad, Telangana, India
Opca bolnica Karlovac
🇭🇷Karlovac, Croatia
Chase Medical Research LLC
🇺🇸Waterbury, Connecticut, United States
Kaplan MC
🇮🇱Rehovot, Israel
Clínica Omega Diabetes, S.C.
🇲🇽Mexico City, México, D.F., Mexico
Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
🇵🇱Gorzow Wielkopolski, Lubuskie, Poland
Prywatny Gabinet Janusz Gumprecht
🇵🇱Zabrze, Poland
Polyclinic #2 in Yoshkar-Ola
🇷🇺Yoshkar-Ola, Russian Federation
MEDISPEKTRUM s.r.o.
🇸🇰Bratislava, Slovakia
SIN AZUCAR s.r.o.
🇸🇰Malacky, Slovakia
Osmania General Hospital
🇮🇳Hyderabad, Telengana, India
Gandhi Hospital & Medical college
🇮🇳Hyderabad, Telengana, India
Diabetes Clinic Wolfson MC
🇮🇱Holon, Israel
The Diabetes Center, LLC
🇺🇸Murrells Inlet, South Carolina, United States
Diabetes Unit Hadassah Ein Karem MC
🇮🇱Jerusalem, Israel
Wakakusa Clinic
🇯🇵Shimotsuke-shi, Tochigi, Japan
Voronezh Regional Clinical Consultive-diagnostic Centre
🇷🇺Voronezh, Russian Federation
Diabetologicka ambulancia SchronerMED, s.r.o.
🇸🇰Moldava nad Bodvou, Slovakia
ARETEUS s.r.o.
🇸🇰Trebisov, Slovakia
Manati Ctr For Clin Research
🇵🇷Manati, Puerto Rico
Tokuyama clinic
🇯🇵Chiba, Japan
Oyama East Clinic
🇯🇵Tochigi, Japan
NBR Polska Tomasz Klodawski
🇵🇱Warsaw, Mazowieckie, Poland
Siberian State Medical University
🇷🇺Tomsk, Russian Federation
Diabetologicka a endokrinologicka ambulancia
🇸🇰Bratislava, Slovakia
Shinden Higashi Clinic_Miyagi
🇯🇵Miyagi, Japan
Noritake Clinic
🇯🇵Ushiku-shi, Ibaraki, Japan
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
🇵🇱Bialystok, Podlaskie, Poland
SAHI Kuzbass Hospital(former Regional clinical hospital)
🇷🇺Kemerovo, Russian Federation
Leningrad Regional Clinical Hospital
🇷🇺Saint Petersburg, Russian Federation
Consultative & Diagnostic Center with a Outpatient Hospital
🇷🇺Saint-Petersburg, Russian Federation
MediVet s.r.o.
🇸🇰Malacky, Slovakia
Hospital Universitario Dr. José Eleuterio González
🇲🇽Monterrey, Nuevo León, Mexico
Investigación Médica Sonora S.C.
🇲🇽Hermosillo, Sonora, Mexico
Centrum Medyczne "Diabetika"
🇵🇱Radom, Poland
Penza Regional Clinical Hospital named after N.N. Burdenko
🇷🇺Penza, Russian Federation
Peter Farkas MD, s.r.o.
🇸🇰Sahy, Slovak Republic, Slovakia
InstitutoJalisciense de Investigación en Diabetes y Obesidad
🇲🇽Guadalajara, Jalisco, Mexico
Florida Inst For Clin Res
🇺🇸Orlando, Florida, United States
Policlinico Umberto I Seconda Clinica Medica
🇮🇹Roma, RM, Italy
Christian Medical College Hospital, Vellore
🇮🇳Vellore, Tamil Nadu, India
Lakeview Clinical Research, LLC
🇺🇸Guntersville, Alabama, United States
Valley Research
🇺🇸Fresno, California, United States
American Clinical Trials
🇺🇸Buena Park, California, United States
Coastal Metabolic Research Center
🇺🇸Ventura, California, United States
Desert Oasis Hlthcr Med Group
🇺🇸Palm Springs, California, United States
First Valley Medical Group
🇺🇸Lancaster, California, United States
East Coast Institute for Research, LLC
🇺🇸Jacksonville, Florida, United States
Suncoast Clin Res Port Richey
🇺🇸New Port Richey, Florida, United States
Palm Harbor Medical Associates
🇺🇸Palm Harbor, Florida, United States
Metabolic Research Institute Inc
🇺🇸West Palm Beach, Florida, United States
Clinical Invest Special_Gurnee
🇺🇸Gurnee, Illinois, United States
Iowa Diab & Endo Res Center
🇺🇸West Des Moines, Iowa, United States
MedStar Hlth Res Institute
🇺🇸Hyattsville, Maryland, United States
Four Rivers Clinical Research Inc
🇺🇸Paducah, Kentucky, United States
Endo And Metab Cons
🇺🇸Rockville, Maryland, United States
Arcturus Healthcare, PLC.
🇺🇸Troy, Michigan, United States
Southgate Medical Group, LLP
🇺🇸West Seneca, New York, United States
Albuquerque Clin Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
Physicians East Endocrinology
🇺🇸Greenville, North Carolina, United States
N.Y. Total Medical Care PC
🇺🇸Brooklyn, New York, United States
Hillcrest Clinical Research
🇺🇸Simpsonville, South Carolina, United States
Medication Management, LLC
🇺🇸Raleigh, North Carolina, United States
Accellacare
🇺🇸Wilmington, North Carolina, United States
Providence Health Partners Ctr
🇺🇸Dayton, Ohio, United States
Fmc Science, Llc
🇺🇸Lampasas, Texas, United States
Clinical Trials of Texas, LLC
🇺🇸San Antonio, Texas, United States
NE Clin Res of San Antonio
🇺🇸San Antonio, Texas, United States
Simcare Medical Research, LLC
🇺🇸Sugar Land, Texas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
TPMG Clinical Research
🇺🇸Newport News, Virginia, United States
Rainier Clin Res Ctr Inc
🇺🇸Renton, Washington, United States
KBC Rijeka, Endokrinologija
🇭🇷Rijeka, Croatia
Opca bolnica Varazdin
🇭🇷Varazdin, Croatia
Poliklinika SLAVONIJA OSIJEK
🇭🇷Osijek, Osječko - Baranjska Županija, Croatia
PGIMS Rohtak
🇮🇳Rohtak, Haryana, India
BYL Nair Hospital and T N Medical College Department of endo
🇮🇳Mumbai, Maharashtra, India
TOTALL Diabetes Hormone Institute
🇮🇳Indore, Madhya Pradesh, India
chelleram Diabetes Institute
🇮🇳Pune, Maharashtra, India
Policlinico Mater Domini Università di Catanzaro
🇮🇹Catanzaro, Italy
Sugimoto Clinic,Internal Medicine
🇯🇵Kitakyusyu-shi, Fukuoka, Japan
Azienda Ospedaliera Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Ospedale Maggiore Policlinico UO Endocrinologia Diabetolgia
🇮🇹Milano, Italy
Unità Funzionale di nutrizione clinica cod 58.01.3
🇮🇹Palermo, Italy
Hayashi Diabetes Clinic
🇯🇵Chigasaki-shi, Kanagawa, Japan, Japan
Diabetes Clinic Meir MC
🇮🇱Kfar Saba, Israel
The University of Tokyo Hospital, Diabetes and Metabolic
🇯🇵Bunkyo-ku, Tokyo, Japan
Heiwadai Hospital
🇯🇵Miyazaki-shi, Miyazaki, Japan
Naka Kinen Clinic
🇯🇵Ibaraki, Japan
Futata Tetsuhiro Clinic Meinohama
🇯🇵Fukuoka-shi, Fukuoka, Japan
Toranomon Hospital, Endocrinology and Metabolism
🇯🇵Minato-ku, Tokyo, Japan
Takatsuki Red Cross Hospital
🇯🇵Osaka, Japan
NZOZ "CenterMed Lublin" Sp. z o.o.
🇵🇱Lublin, Lubelskie, Poland
NZOZ Przychodnia Specjalistyczna Medica
🇵🇱Lublin, Lubelski, Poland
Centrum Zdrowia Tuchow Sp z o.o.
🇵🇱Wierzchoslawice, Poland
Advanced Clinical Research LLC
🇵🇷Bayamon, Puerto Rico
National Medical Research Center of Endocrinology
🇷🇺Moscow, Russian Federation
Limited Law Company "Healthy Family" Medicine Center"
🇷🇺Novosibirsk, Russian Federation
Setchenov First Moscow State Medical University
🇷🇺Moscow, Russian Federation
Scientifc Institute of Clinical and Experimental Lymphology
🇷🇺Novosibirsk, Russian Federation
Limited Liability Company "Energiya Zdoroviya"
🇷🇺Saint-Petersburg, Russian Federation
Regional clinical cardiology dispensary
🇷🇺Saratov, Russian Federation
Complejo Hospitalario Universitario A Coruña
🇪🇸La Coruña, Spain
Hospital Quirón
🇪🇸Pozuelo de Alarcon, Spain
Layton Medical Centre
🇬🇧Blackpool, United Kingdom
ABS La Roca del Vallés
🇪🇸La Roca del Vallés, Spain
Bollington Medical Centre
🇬🇧Bollington, United Kingdom
The Health Centre
🇬🇧Bradford-on-Avon, United Kingdom
Addenbrooke's Hospital_Cambridge
🇬🇧Cambridge, United Kingdom
Southmead Hospital
🇬🇧Bristol, United Kingdom
The Adam Practice
🇬🇧Dorset, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Burbage Surgery
🇬🇧Hinckley, United Kingdom
The Staploe Medical Centre
🇬🇧Soham, United Kingdom
Joint Clinical Research Facility - Swansea
🇬🇧Swansea, United Kingdom
Royal Cornwall Hospital (Treliske)
🇬🇧Truro, United Kingdom
Albany House Medical Centre
🇬🇧Wellingborough, United Kingdom
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain
Centro de Especialidades José Marva
🇪🇸Madrid, Spain
East West Medical Research Institute_Honolulu
🇺🇸Honolulu, Hawaii, United States
Univ of Nebraska Medical CTR
🇺🇸Omaha, Nebraska, United States