Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05352815
Other study ID # NN1535-4591
Secondary ID U1111 1260 82592
Status Completed
Phase Phase 3
First received
Last updated
Start date June 1, 2022
Est. completion date April 23, 2024

Study information

Verified date May 2024
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin icodec taken once a week in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin icodec. Participants will either get IcoSema or insulin icodec. Which treatment participants get is decided by chance. IcoSema and insulin icodec are both new medicines that doctors cannot prescribe. Participants will get IcoSema or insulin icodec, which participants must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will have 21 clinic visits, 31 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. Not applicable for China: Participants will be asked to wear a sensor that measures their blood sugar level all the time during a 5 week period at the end of the study.


Recruitment information / eligibility

Status Completed
Enrollment 1291
Est. completion date April 23, 2024
Est. primary completion date March 18, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key inclusion criteria 1. Male or female and age above or equal to 18 years at the time of signing informed consent. 2. Diagnosed with type 2 diabetes mellitus 180 days or more before screening. 3. HbA1c of 7.0 10.0% (53.0 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening. 4. Treated with once daily or twice daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20- 80 units/day for 90 days or more before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti diabetic drugs with stable doses for 90 days or more before screening: - Metformin - Sulfonylureas (a) - Meglitinides (glinides) (a) - DPP 4 inhibitors (a) - Sodium glucose co transporter 2 inhibitors - Alpha glucosidase inhibitors - Thiazolidinediones - Marketed oral combination products only including the products listed above. 5. Body mass index (BMI) below or equal to 40.0 kg/m^2. (a) Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation. Key exclusion criteria 1. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. 2. Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids). 3. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. 4. Any episodes (as declared by the participant or in the medical records.) of diabetic ketoacidosis within 90 days before screening. 5. Presence or history of pancreatitis (acute or chronic) within 180 days before screening. 6. Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening. 7. Chronic heart failure classified as being in New York Heart Association Class IV at screening. 8. Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator. 9. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before 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


Related Conditions & MeSH terms


Intervention

Drug:
IcoSema
Participants will receive once weekly IcoSema subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.
Insulin icodec
Participants will receive once weekly Insulin icodec subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.

Locations

Country Name City State
Australia Holdsworth House Clinical Research Darlinghurst New South Wales
Australia Barwon Health (The Geelong Hospital) Geelong Victoria
Australia Royal Brisbane and Women's Hospital Herston Queensland
Australia Novatrials Kotara New South Wales
Australia Launceston General Hospital Launceston Tasmania
Australia The Alfred Hospital Melbourne Victoria
Australia Southern Adelaide Diabetes & Endocrine Services Oaklands Park South Australia
Australia Illawarra Diabetes Service Clinical Trials & Research Unit Wollongong New South Wales
Belgium Imeldaziekenhuis - Bonheiden - Department of Endocrinology Bonheiden
Belgium Universitair Ziekenhuis Brussel - Diabeteskliniek Brussel
Belgium Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie Bruxelles
Belgium UZA - UZ Antwerpen - Department of Endocrinology Edegem
Belgium AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie Kortrijk
Belgium UZ Leuven - Endocrinology Leuven
Bulgaria "IPSMC - d-r Nikolay Kostadinov" EOOD Burgas
Bulgaria 'Medical center Medi city 21' OOD Kyustendil
Bulgaria DCC I- Pleven EOOD Pleven
Bulgaria UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases Plovdiv
Bulgaria MMA-MHAT Sofia, Clinic of Endocrinology and Metab. Diseases Sofia
China Peking University People's Hospital Beijing Beijing
China Changzhou No.2 People's Hospital, Yanghu Branch Changzhou Jiangsu
China The First People's Hospital of Changzhou Changzhou Jiangsu
China Chongqing University Three Gorges Hospital ChongQing Chongqing
China Anhui Provincial Hospital Hefei Anhui
China Harrison International Peace Hospital Hengshui Hebei
China Huizhou Central People's Hospital Huizhou Guangdong
China Jinan Central Hospital Ji'nan Shandong
China Huaihe Hospital of Henan University Kaifeng Henan
China The Second Affiliated Hospital of Nanjing Medical University_Nanjing Nanjing Jiangsu
China Shanghai Fifth People's Hospital Shanghai Shanghai
China The Second Affiliated Hospital of Soochow University Suzhou Jiangsu
China General Hospital of Tianjin Medical University Tianjin Tianjin
China The Second Hospital of Tianjin Medical University Tianjin Tianjin
China The Affiliated Hospital of Jiangsu University_Zhenjiang Zhenjiang Jiangsu
Croatia Klinicki bolnicki centar Osijek Osijek
Croatia Poliklinika SLAVONIJA OSIJEK Osijek Osjecko - Baranjska Županija
Croatia Opca bolnica Pula Pula
Croatia KBC Rijeka, Endokrinologija Rijeka
Croatia Poliklinika Solmed Zagreb Grad Zagreb
Finland Ähtärin terveysasema Ähtäri
Finland Health Step Finland Oy Kuopio
Finland Raision sosiaali- ja terveyskeskus Raisio
Finland Tampereen diabetesvastaanotto Tampere
Finland Turku University Hospital Turku
India Gujarat Endocrine Centre Ahmedabad Gujarat
India Post Graduate Institute of Medical Education & Research Chandigarh Punjab
India M.V.Hospital for Diabetes Pvt. Ltd. Chennai Tamil Nadu
India S.C.B. Medical College Cuttack Orissa
India Osmania General Hospital Hyderabad Telengana
India Ramdev Rao Hospital Hyderabad Telangana
India TOTALL Diabetes Hormone Institute Indore Madhya Pradesh
India Excel Endocrine Centre Kolhapur Maharashtra
India Government Medical College, Kozhikode Kozhikode Kerala
India Dayanand Medical College & Hospital_Ludhiana Ludhiana Punjab
India Arthur Asirvatham hospital, Madurai Tamil Nadu
India BYL Nair Hospital and T N Medical College Department of endo Mumbai Maharashtra
India Seth GS medical college and KEM Hospital Mumbai Maharashtra
India Lady Hardinge Medical College New Delhi
India Jothydev's Diabetes & Research Center Thriruvananthapuram Kerala
Italy A.O.U. Consorziale Policlinico di Bari Bari BA
Italy Policlinico Mater Domini Università di Catanzaro Catanzaro
Italy ASL 4 Chiavarese Chiavari (genova)
Italy ASST Grande Ospedale Metropolitano Niguarda Milano
Japan Kumanomae Nishimura Internal Medical Clinic Arakawa-ku, Tokyo
Japan Akaicho Clinic Chiba-shi, Chiba
Japan Hayashi Diabetes Clinic Chigasaki-shi Kanagawa, Japan
Japan Hayashi Diabetes Clinic Chigasaki-shi, Kanagawa Kanagawa, Japan
Japan Futata Tetsuhiro Clinic Meinohama Fukuoka-shi, Fukuoka
Japan Kunisaki Makoto Clinic Fukuoka-shi, Fukuoka
Japan Sasaki Hospital Internal Medicine Hokkaido
Japan Seino Internal Medicine Clinic Koriyama-shi Fukushima, Japan
Japan Yoshimura clinic Kumamoto
Japan Jinnouchi Hospital Kumamoto-shi Kumamoto, Japan
Japan Heiwadai Hospital Miyazaki-shi Miyazaki
Japan Hisatomi Clinic Saga-shi, Saga
Japan Manda Memorial Hospital Sapporo-shi, Hokkaido Hokkaido, Japan
Japan Fukuwa Clinic Tokyo
Japan Tokyo-Eki Center-building Clinic Tokyo
Japan Yokohama City University Hospital, Endocrinology, Metabolism Yokohama-shi, Kanagawa
Korea, Republic of Korea University Ansan Hospital Ansan Gyeonggi-do
Korea, Republic of Soonchunhyang University Hospital Cheonan Chungcheongnam-do
Korea, Republic of Seoul National University Bundang Hospital_Seongnam-si Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Nowon Eulji Medical Center, Eulji University Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Seoul Saint Mary's Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of Wonju Severance Christian Hospital Wonju
Mexico Centro de Investigación Cardiometabólica de Aguascalientes Aguascalientes
Mexico Clínicos Asociados BOCM, S.C. Mexico City
Mexico Hospital Universitario Dr. José Eleuterio González_Monterrey Monterrey Nuevo León
Norway Nordlandssykehuset Bodø Bodø
Norway Drammen sykehus - Vestre Viken HF Drammen
Norway Sykehuset Innlandet HF Hamar Hamar
Norway Oslo universitetssykehus Aker Oslo
Norway St. Olavs Hospital HF Trondheim
Poland Uniwersyteckie Centrum Kliniczne (UCK) Gdansk
Poland NZOZ "CenterMed Lublin" Sp. z o.o. Lublin
Poland NZOZ Przychodnia Specjalistyczna Medica Lublin Lubelski
Poland Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji Warszawa
Portugal Hospital Garcia de Orta Almada
Portugal Hospital Infante D. Pedro - Aveiro Aveiro
Portugal Hospital de Braga Braga
Portugal Centro Hospitalar Lisboa Ocidental Lisboa
Portugal Hospital da Luz Lisboa
Portugal Unidade Local de Saúde de Matosinhos Matosinhos
Portugal Hospital da Luz Arrabida Vila Nova de Gaia
Puerto Rico Advanced Clinical Research LLC Bayamon
Puerto Rico Manati Ctr For Clin Research Manati
Romania CMI Diabet, Nutritie, Boli Metabolice "Dr Pop Lavinia" Baia Mare Maramures
Romania Mariodiab Clinic SRL Brasov
Romania Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila Bucharest Bucurestii
Romania SC Consultmed SRL Iasi
Romania Clinica Korall S.R.L. Satu Mare Satu-Mare
Romania Hospital Sf. Ioan cel Nou Suceava
Russian Federation Arkhangelsk Regional Clinical Hospital Arkhangelsk
Russian Federation Sverdlovsk Regional Clinical Hospital #1 Ekaterinburg
Russian Federation Irkutsk State Medical Academy of Postgraduate Education Irkutsk
Russian Federation Limited Liability Company "AriVa-Med" Kursk
Russian Federation City Consultative & Diagnostic Centre #1 Saint-Petersburg
Russian Federation Saratov regional clinical hospital Saratov
Russian Federation Tumen State Medical University Tumen Russia
Serbia Endocrinology, Diabetes and Metabolism Diseases Clinic Belgrade
South Africa Netcare Alberton Hospital Alberton
South Africa Armansis Medical Centre Brits North West
South Africa Langeberg Clinical Trials Cape Town Western Cape
South Africa Dr Pillay's Rooms Durban KwaZulu-Natal
South Africa Deepak Lakha Johannesburg Gauteng
South Africa Hemant Makan Johannesburg Gauteng
South Africa Wits Bara Clinical Trial Site Johannesburg Gauteng
Taiwan Changhua Christian Hospital Changhua City
Taiwan China Medical University Hospital Taichung
Taiwan Chi Mei Medical Center Tainan City
Taiwan National Cheng Kung University Hospital Tainan City
Taiwan Taipei Medical University Hospital Taipei city
Turkey Cukurova Universitesi Tip Fakultesi Adana
Turkey Ankara Universitesi Ibni Sina Hastanesi Ankara Altindag
Turkey Gulhane Egitim Arastirma Hastanesi Ankara
Turkey Haseki Sultangazi Istanbul
Turkey T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital Istanbul
Turkey T.C. S.B. Ist Il SagMud Pendik Egitim ve Arastirma Hastanesi Istanbul
Turkey Tekirdag Namik Kemal UTF Tekirdag
United States Javara/Privia Med Grp GA,LLC Albany Georgia
United States Albuquerque Clin Trials, Inc. Albuquerque New Mexico
United States Amarillo Med Spec LLP Amarillo Texas
United States Emory University SOM Atlanta Georgia
United States Texas Diabetes & Endocrinology, P.A._Austin Austin Texas
United States Texas Diabetes & Endocrinology, P.A._Austin Austin Texas
United States AM Diabetes And Endocrinology Center Bartlett Tennessee
United States Brigham & Women's Hospital Boston Massachusetts
United States Holston Medical Group_Bristol Bristol Tennessee
United States Northern Pines Hlth Ctr, PC Buckley Michigan
United States Clinical Res Of W Florida Inc Clearwater Florida
United States Central Ohio Clinical Research LLC Columbus Ohio
United States John Muir Physicians Network Concord California
United States Univ of TX SW Med Ctr Dallas Dallas Texas
United States Velocity Clinical Res-Dallas Dallas Texas
United States Creekside Endocrine Associates, PC Denver Colorado
United States Headlands Research California, LLC Escondido California
United States Javara Inc. Fayetteville Georgia
United States Northeast Research Institute Fleming Island Florida
United States Elite Research Center Flint Michigan
United States Javara Inc/Privia Md GpLLC Fst Forest Virginia
United States Pri Med Grp dba/Gil Ctr Fam Gilbert Arizona
United States PharmQuest Life Sciences LLC Greensboro North Carolina
United States Javara Inc. / Privia Medical Group Gulf Coast PLLC Houston Texas
United States PlanIt Research, PLLC Houston Texas
United States PrimeCare Medical Group Houston Texas
United States Protenium Clinical Research Hurst Texas
United States MedStar Hlth Res Institute Hyattsville Maryland
United States Jefferson City Medical Group, PC Jefferson City Missouri
United States Scripps Whittier Diabetes Inst La Jolla California
United States Andres Garcia-Zuniga, MD, P.A Laredo Texas
United States Milton Haber, M.D. Laredo Texas
United States Palm Research Center Inc. Las Vegas Nevada
United States Physicians Research Assoc. LLC Lawrenceville Georgia
United States The Research Group of Lexington LLC Lexington Kentucky
United States Medical Investigations, Inc. Little Rock Arkansas
United States Torrance Clin Res Inst, Inc. Lomita California
United States DCOL Ctr for Clin Res Longview Texas
United States Pacific Clinical Studies Los Alamitos California
United States Downtown LA Res Ctr. Inc. Los Angeles California
United States Velocity Clin Res Wstlke Los Angeles California
United States International Diabetes Center Minneapolis Minnesota
United States HealthStar Physicians PC Morristown Tennessee
United States Southern New Hampshire Diabete Nashua New Hampshire
United States New Orleans Center for Clinical Research New Orleans Louisiana
United States Suncoast Clin Res Port Richey New Port Richey Florida
United States Mid Hudson Medical Research, PLLC New Windsor New York
United States Eastern Virginia Medical School Norfolk Virginia
United States Valley Clinical Trials, Inc. Northridge California
United States Methodist Physicians Clinic Diabetes and Endocrinology Specialists Omaha Nebraska
United States University of NE Med Ctr Omaha Nebraska
United States Texas Diabetes & Endocinology Round Rock Texas
United States Briggs Clinical Research, LLC San Antonio Texas
United States Sun Research Institute San Antonio Texas
United States Javara Inc Privia Grp Gulf Cst San Marcos Texas
United States NorCal Endocrinology and Internal Medicine San Ramon California
United States NorthShore Univ Hlth Sys Skokie Illinois
United States Ileana J Tandron APMC Slidell Louisiana
United States SimCare, PLLC Sugar Land Texas
United States Cotton O'Neil Clin Research Ctr Topeka Kansas
United States New Venture Medical Research Wadsworth Ohio
United States Diablo Clinical Research, Inc. Walnut Creek California
United States Iowa Diab & Endo Res Center West Des Moines Iowa
United States Metabolic Research Institute Inc West Palm Beach Florida
United States Southgate Medical Group, LLP West Seneca New York
United States Amherst Family Practice P.C. Winchester Virginia

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  China,  Croatia,  Finland,  India,  Italy,  Japan,  Korea, Republic of,  Mexico,  Norway,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  South Africa,  Taiwan,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in glycated haemoglobin (HbA1c) % point From baseline week 0 (V2) to week 52 (V54)
Secondary Change in body weight Kg From baseline week 0 (V2) to week 52 (V54)
Secondary 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) Number of episodes From baseline week 0 (V2) to week 57 (V56)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2