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
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Insulin Glargine 100U/mLDrug: Insulin Glargine 300U/mL
- Registration Number
- NCT04760626
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1085
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Once daily basal insulin analogues Insulin Glargine 100U/mL Participants randomised to basal insulin analogue injections once daily Once daily basal insulin analogues Insulin Glargine 300U/mL Participants randomised to basal insulin analogue injections once daily Insulin icodec with DoseGuide Insulin icodec Participants randomised to insulin icodec will use insulin icodec with the DoseGuide App to guide their titration. Once daily basal insulin analogues Insulin Degludec Participants randomised to basal insulin analogue injections once daily
- Primary Outcome Measures
Name Time Method Change in HbA1c (glycated haemoglobin) From baseline week 0 (V2) to week 52 (V6) %-point
- Secondary Outcome Measures
Name Time Method Number of severe hypoglycaemic episodes (level 3) From baseline week 0 (V2) to week 57 (V8) Number of episodes
Time from baseline to treatment discontinuation or intensification From baseline week 0 (V2) to week 52 (V6) Days
Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction From baseline week 0 (V2) to week 52 (V6) Score of 0-36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment.
Trim-D (Treatment Related Impact Measure for Diabetes) compliance domain At end of treatment week 52 (V6) Score of 4-20. 4 items scored on a scale of 1 to 5 Transformed to a 0-100 scale with higher scores corresponding to better compliance.
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) From baseline week 0 (V2) to week 57 (V8) Number of episodes
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) From baseline week 0 (V2) to week 57 (V8) Number of episodes
Trial Locations
- Locations (178)
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
Iatriko Psychicou Private Clinic
🇬🇷Athens, Greece
Korgiallenio - Benakio Hospital (Red Cross Hosp.)
🇬🇷Athens, Greece
"Laiko" General Hospital of Athens
🇬🇷Athens, Greece
Iatriko Athinon 'Palaiou Falirou'
🇬🇷Athens, Greece
Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
🇬🇷Larissa, Greece
General Hospital of Thessaloniki 'G. Gennimatas
🇬🇷Thessaloniki, Greece
AHEPA General University Hospital
🇬🇷Thessaloniki, Greece
"Ippokrateio" General Hosp Thessaloniki, A' Internal Med
🇬🇷Thessaloniki, Greece
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
🇬🇷Thessaloniki, Greece
"Thermi" Private Hosital
🇬🇷Thessaloniki, Greece
Oddzial Chorób - Wewn.
🇵🇱Poznan, Poland
Poradnia dla Chorych na Cukrzycę
🇵🇱Zabrze, Poland
New Venture Medical Research
🇺🇸Wadsworth, Ohio, United States
First Valley Medical Group
🇺🇸Lancaster, California, United States
San Diego Family Care
🇺🇸San Diego, California, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Southgate Medical Group, LLP
🇺🇸West Seneca, New York, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
MedStar Community Clin Res Ctr
🇺🇸Hyattsville, Maryland, United States
Jefferson City Medical Group, PC
🇺🇸Jefferson City, Missouri, United States
Torrance Clin Res Inst, Inc.
🇺🇸Lomita, California, United States
Cotton O'Neil Clin Research Ctr
🇺🇸Topeka, Kansas, United States
San Fernando Valley Hlth Inst
🇺🇸West Hills, California, United States
Suncoast Clinical Research, Inc.
🇺🇸Palm Harbor, Florida, United States
Mid Hudson Medical Research, PLLC
🇺🇸New Windsor, New York, United States
American Clinical Trials
🇺🇸Buena Park, California, United States
Elite Clinical Trials
🇺🇸Blackfoot, Idaho, United States
Diab & Endo Assoc of Stark Co
🇺🇸Canton, Ohio, United States
Palm Research Center Inc-Vegas
🇺🇸Las Vegas, Nevada, United States
Palm Harbor Medical Associates
🇺🇸Palm Harbor, Florida, United States
Endo and Metab Consultants
🇺🇸Rockville, Maryland, United States
Est Cst Inst for Rsrch,Jksnvil
🇺🇸Jacksonville, Florida, United States
Valley Research
🇺🇸Fresno, California, United States
Arcturus Healthcare, PLC.
🇺🇸Troy, Michigan, United States
AM Diabetes And Endocrinology Center
🇺🇸Bartlett, Tennessee, United States
Velocity Clinical Res-Dallas
🇺🇸Dallas, Texas, United States
UT Southwestern Med Cntr
🇺🇸Dallas, Texas, United States
Chattanooga Medical Research, LLC
🇺🇸Chattanooga, Tennessee, United States
Albuquerque Clin Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
Juno Research, LLC
🇺🇸Houston, Texas, United States
Endo Res Solutions, Inc
🇺🇸Roswell, Georgia, United States
Protenium Clinical Research
🇺🇸Hurst, Texas, United States
Northern Pines Hlth Ctr, PC
🇺🇸Buckley, Michigan, United States
Providence Health Partners Ctr
🇺🇸Dayton, Ohio, United States
TPMG Clinical Research
🇺🇸Newport News, Virginia, United States
Endocrine Associates of Long Island, PC
🇺🇸Smithtown, New York, United States
Rivergrove Medical Clinic
🇨🇦Winnipeg, Manitoba, Canada
Andres Garcia-Zuniga, MD, P.A
🇺🇸Laredo, Texas, United States
LMC Endo Ctr (Etobicoke) Ltd
🇨🇦Etobicoke, Ontario, Canada
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
🇩🇪Münster, Germany
Amarillo Med Spec LLP
🇺🇸Amarillo, Texas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
LMC Diabetes & Endocrinology (Barrie)
🇨🇦Barrie, Ontario, Canada
LMC (Thornhill)
🇨🇦Concord, Ontario, Canada
Univ Diab & Endo Consultants
🇺🇸Chattanooga, Tennessee, United States
Texas Diab & Endo, P.A.
🇺🇸Round Rock, Texas, United States
PrimeCare Medical Group
🇺🇸Houston, Texas, United States
HealthStar Physicians PC
🇺🇸Morristown, Tennessee, United States
Zentrum für klinische Forschung, Dr. med. Lüdemann
🇩🇪Falkensee, Germany
Clinical Inv Spec, Inc.Kenosha
🇺🇸Kenosha, Wisconsin, United States
Centricity Research LMC
🇨🇦Brampton, Ontario, Canada
Medical Colleagues-Texas LLP
🇺🇸Katy, Texas, United States
Fmc Science, Llc
🇺🇸Lampasas, Texas, United States
The Bailey Clinic
🇨🇦Red Deer, Alberta, Canada
Dr. Anil K Gupta Medicine Professional Corporation
🇨🇦Toronto, Ontario, Canada
Western Univ. Cnt for Studies in Fam Med
🇨🇦London, Ontario, Canada
LMC Research Inc. Ottawa
🇨🇦Nepean, Ontario, Canada
Winnipeg Clinic
🇨🇦Winnipeg, Manitoba, Canada
ViaCar Recherche Clinique Inc
🇨🇦Brossard, Quebec, Canada
Diex Recherche Quebec Inc.
🇨🇦Quebec, Canada
LMC Clin Rsrch Inc. (Montreal)
🇨🇦Saint-Laurent, Quebec, Canada
InnoDiab Forschung GmbH
🇩🇪Essen, Germany
Belinus Bt.
🇭🇺Debrecen, Hajdu-Bihar Varmegye, Hungary
'G. Gennimatas' General Hospital of Athens
🇬🇷Athens, Greece
Diex Recherche Victoriaville
🇨🇦Victoriaville, Quebec, Canada
Recherche Clinique Sigma inc
🇨🇦Quebec, Canada
Wendisch/Dahl Hamburg
🇩🇪Hamburg, Germany
Óbudai Egészségügyi Centrum
🇭🇺Budapest, Hungary
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
🇭🇺Szeged, Hungary
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
🇭🇺Budapest, Hungary
MedicalCenter am Clemenshospital
🇩🇪Münster, Germany
Diabetespraxis Mergentheim
🇩🇪Bad Mergentheim, Germany
Milek, Hohenmölsen
🇩🇪Hohenmölsen, Germany
Baskent Universitesi Adana
🇹🇷Adana, Turkey
Ankara Universitesi Ibni Sina Hastanesi
🇹🇷Ankara, Turkey
Bieler, Riesa
🇩🇪Riesa, Germany
Kaposi Mór Oktató Kórház
🇭🇺Kaposvár, Hungary
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
🇩🇪Berlin, Germany
Uno Medical Trials Eü. Szolgáltató és Kereskedelmi Kft.
🇭🇺Budapest, Hungary
Centrum Medyczne Pratia Katowice
🇵🇱Katowice, Poland
Katedra i Klinika Chorob Wewnetrznych AM w Lublinie
🇵🇱Lublin, Poland
Gaziantep Universitesi Tip Fakultesi Hastanesi
🇹🇷Gaziantep, Turkey
MED-TIMA Kft.
🇭🇺Budapest, Hungary
Centrum Medyczne Pratia Gdynia
🇵🇱Gdynia, Pomorskie, Poland
Pro Salus Centrum Medyczne
🇵🇱Lodz, Poland
Lubelskie Centrum Diagnostyczne Tomasz Blicharski
🇵🇱Swidnik, Poland
Hatay Mustafa Kemal Universitesi Saglik Uygulama ve Arastirm
🇹🇷Hatay, Turkey
Markusovszky Egyetemi Oktatókórház
🇭🇺Szombathely, Hungary
Szőcs Depot Egészségügyi Szolgáltató Kft.
🇭🇺Budapest, Hungary
MH Egészségügyi Központ
🇭🇺Budapest, Hungary
NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.
🇵🇱Gdansk, Poland
Gabinet Lekarski Malgorzata Saryusz-Wolska
🇵🇱Lodz, Poland
Manati Ctr For Clin Research
🇵🇷Manati, Puerto Rico
Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi
🇹🇷Istanbul, Turkey
T.C. S.B. Ist Il SagMud Pendik Egitim ve Arastirma Hastanesi
🇹🇷Istanbul, Turkey
Clinical Trials of Texas, LLC
🇺🇸San Antonio, Texas, United States
NE Clin Res of San Antonio
🇺🇸San Antonio, Texas, United States
G.A. Research Associates Ltd.
🇨🇦Moncton, New Brunswick, Canada
Eastern Health Authority
🇨🇦St. Johns, Newfoundland and Labrador, Canada
Commonwealth Medical Clinic
🇨🇦Mount Pearl, Newfoundland and Labrador, Canada
Dr. M.B. Jones Inc
🇨🇦Victoria, British Columbia, Canada
Selye János Kórház és Rendelőintézet
🇭🇺Komárom, Komárom-Esztergom, Hungary
Univ of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi
🇹🇷Istanbul, Turkey
Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji
🇹🇷Istanbul, Turkey
Haydarpasa Numune Hastanesi
🇹🇷Istanbul, Turkey
Medical Trust Clinics, Inc.
🇨🇦Courtice, Ontario, Canada
Wharton Med Clin Trials
🇨🇦Hamilton, Ontario, Canada
Hamilton Med Res Group
🇨🇦Hamilton, Ontario, Canada
Milestone Research
🇨🇦London, Ontario, Canada
LMC Oakville
🇨🇦Oakville, Ontario, Canada
Bluewater Clin Res Group,Inc
🇨🇦Sarnia, Ontario, Canada
Winterberry Family Medicine
🇨🇦Stoney Creek, Ontario, Canada
LMC Endo Centres Ltd.(Bayview)
🇨🇦Toronto, Ontario, Canada
Ecogene-21
🇨🇦Chicoutimi, Quebec, Canada
Manna Research Mirabel
🇨🇦Mirabel, Quebec, Canada
Ctr de rech Clin de Laval
🇨🇦Laval, Quebec, Canada
Applied Med Inf Res
🇨🇦Montreal, Quebec, Canada
Diex Recherche Joliette
🇨🇦Saint-Charles-Borromee, Quebec, Canada
Ctr Méd. et pro d l'Ost d port
🇨🇦St-Marc-des-Carrières, Quebec, Canada
Centre de Recherche Saint-Louis
🇨🇦Quebec, Canada
Lakeview Clinical Research, LLC
🇺🇸Guntersville, Alabama, United States
RED-Institut für medizinische Forschung und Fortbildung GmbH
🇩🇪Oldenburg in Holstein, Germany
Praxis Dr. med. Wenzl-Bauer
🇩🇪Rehlingen-Siersburg, Germany
Zentrum für klinische Studien Allgäu Oberschwaben
🇩🇪Wangen, Germany
Methodist Physicians Clin
🇺🇸Omaha, Nebraska, United States
Univ of Nebraska Medical CTR
🇺🇸Omaha, Nebraska, United States
Zala Megyei Szent Rafael Kórház
🇭🇺Zalaegerszeg, Hungary
Simcare Medical Research, LLC
🇺🇸Sugar Land, Texas, United States
Scripps Whittier Diabetes Inst
🇺🇸La Jolla, California, United States
Adult Medicine of Lake County, Inc.
🇺🇸Mount Dora, Florida, United States
Encompass Clinical Research_Spring Valley
🇺🇸Spring Valley, California, United States
Suncoast Clin Res Port Richey
🇺🇸New Port Richey, Florida, United States
Southern New Hampshire Diabetes and Endocrinology
🇺🇸Nashua, New Hampshire, United States
Albany Medical College - Endo
🇺🇸Albany, New York, United States
Physicians East Endocrinology
🇺🇸Greenville, North Carolina, United States
Plains Clinical Research Center, LLC_Fargo
🇺🇸Fargo, North Dakota, United States
Accellacare
🇺🇸Wilmington, North Carolina, United States
The Diabetes Center, LLC
🇺🇸Murrells Inlet, South Carolina, United States
Hillcrest Clinical Research
🇺🇸Simpsonville, South Carolina, United States
LMC Clin Res Inc. Calgary
🇨🇦Calgary, Alberta, Canada
Erlinger
🇩🇪Stuttgart, Germany
Zentrum für klinische Studien Alexander Segner
🇩🇪Saint Ingbert-Oberwürzbach, Germany
"Ippokrateio" G.H. of Thessaloniki
🇬🇷Thessaloniki, Greece
General Hospital of Thessaloniki "G.Papanikolaou"
🇬🇷Thessaloniki, Greece
Szent Margit Kórház
🇭🇺Budapest, Hungary
Velocity Nova Sp. z o.o.
🇵🇱Staszow, Poland
T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
🇹🇷Adana, Turkey
T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital
🇹🇷Istanbul, Turkey
Umraniye Egitim ve Arastirma Hastanesi
🇹🇷Istanbul, Turkey
Dokuz Eylul University Medical Faculty
🇹🇷Izmir, Turkey
Erciyes Universitesi Tip Fakultesi
🇹🇷Kayseri, Turkey
Advanced Investigative Medicine, Inc.
🇺🇸Hawthorne, California, United States
Wade Family Medicine
🇺🇸Bountiful, Utah, United States
Metabolic Research Institute Inc
🇺🇸West Palm Beach, Florida, United States
Coastal Metabolic Research Center
🇺🇸Ventura, California, United States
Medication Management, LLC
🇺🇸Raleigh, North Carolina, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Desert Oasis Hlthcr Med Group
🇺🇸Palm Springs, California, United States
NorCal Endocrinology and Internal Medicine
🇺🇸San Ramon, California, United States
N.Y. Total Medical Care PC
🇺🇸Brooklyn, New York, United States
Texas Diabetes & Endocrinology
🇺🇸Austin, Texas, United States
Clinical Trials Research_Sacramento
🇺🇸Sacramento, California, United States
Florida Inst For Clin Res
🇺🇸Orlando, Florida, United States
Central Illinois Diabetes and Clinical Research
🇺🇸Springfield, Illinois, United States
Diabetes/Lipid Mgmt & Res Ctr
🇺🇸Huntington Beach, California, United States
Clinical Research of Central Florida_Winter Haven
🇺🇸Winter Haven, Florida, United States