Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05013229
Other study ID # NN1535-4593
Secondary ID U1111-1260-82952
Status Completed
Phase Phase 3
First received
Last updated
Start date November 30, 2021
Est. completion date November 14, 2023

Study information

Verified date February 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 glargine taken daily with insulin aspart 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 glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries. Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines 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 be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.


Recruitment information / eligibility

Status Completed
Enrollment 679
Est. completion date November 14, 2023
Est. primary completion date November 14, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female and age above or equal to 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus 180 days or more before screening. - HbA1c of 7.0-10.0 percentage (53.- 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening. - 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 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 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. - Body mass index (BMI) less than or equal to 40.0 kg/m^2. 1. Sulfonylureas, meglitinides (glinides) and DPP-4 inhibitors must be discontinued at randomisation. Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. - 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). - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. - Any episodes of diabetic ketoacidosis within 90 days before screening. As declared by the participant or in the medical records. - Presence or history of pancreatitis (acute or chronic) within 180 days before screening. - Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening. - Chronic heart failure classified as being in New York Heart Association Class IV at screening. - Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator. - 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 a once weekly subcutanous (s.c.) injection of IcoSema, on the same day every week for 52 weeks.
Insulin glargine
Participants will receive a once daily subcutaneous (s.c.) injection of insulin glargine combined with Insulin aspart 2-4 times a day during mealtimes for 52 weeks.
insulin aspart
Participants will receive a once daily subcutaneous (s.c.) injection of insulin glargine combined with Insulin aspart 2-4 times a day during mealtimes for 52 weeks.

Locations

Country Name City State
Czechia University Hospital U sv. Anny Brno
Czechia University Hospital U sv. Anny Brno
Czechia FN Hradec Kralove Hradec Kralove
Czechia Fakultni nemocnice Plzen Plzen Czech Republic
Czechia Fledip s.r.o. Praha
Czechia III. interni klinika VFN a 1. LK UK v Praze Praha
Czechia Institut klinicke a experimentalni mediciny_Praha Praha
Czechia Diabet2 s.r.o. Praha 1
Czechia Diabetologická a interní ambulance Diabet2 Praha 1
Czechia Fledip s.r.o. Praha 6
Czechia ResTrial s.r.o. Praha 8
France Centre Hospitalier Departemental Vendee- La Roche Sur Yon LA ROCHE-sur-YON cedex 9
France Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-2 Le Creusot
France Aphp-Hopital Lariboisiere-1 Paris
France Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2 Pessac
France Groupe Hospitalier Mutualiste Des Portes Du Sud Venissieux
Germany InnoDiab Forschung GmbH Essen
Germany Wendisch/Dahl Hamburg Hamburg
Germany Institut für Diabetesforschung GmbH Münster - Dr. med. Rose Münster
Germany RED-Institut für medizinische Forschung und Fortbildung GmbH Oldenburg in Holstein
Germany Zentrum für klinische Studien Alexander Segner Saint Ingbert-Oberwürzbach
Hungary Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház Békéscsaba
Hungary ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft. Budapest
Hungary Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft. Budapest
Hungary Semmelweis Egyetem II. Belgyógyászati Klinika Budapest
Hungary Szocs Depot Egészségügyi Szolgáltató Kft. Budapest
India Apollo Hospital, Ahmedabad Ahmedabad Gujarat
India Swasthya Diabetes Care Ahmedabad
India Diacon Hospital Private Limited Bangalore Karnataka
India Post Graduate Institute of Medical Education & Research Chandigarh Punjab
India Madras Diabetes Research Foundation Chennai Tamil Nadu
India Apollo Hospital International Ltd Gandhinagar Gujarat
India TOTALL Diabetes Hormone Institute Indore Madhya Pradesh
India Diabetes, Thyroid and Endocrine Centre Jaipur Rajasthan
India Medanta Lucknow Hospital Lucknow Uttar Pradesh
India Christian Medical College and Hospital Ludhiana Punjab
India Fortis Heart Institute and Multispeciality Hospital Mohali Punjab
India chelleram Diabetes Institute Pune Maharashtra
India Sahyadri Speciality Hospital Pune Maharashtra
India Sahyadri Super Speciality Hospital Pune Maharashtra
India Christian Medical College Hospital, Vellore Vellore Tamil Nadu
Italy Azienda Ospedaliero-Universitaria Renato Dulbecco Catanzaro CZ
Italy Azienda Ospedaliera Luigi Sacco Milano
Italy Ospedale Civico Partinico di Palermo Partinico
Italy Pol. Uni. Campus Biomedico UOC Endocrinologia e Diabetologia Roma RM
Italy IRCCS Multimedica Sesto San Giovanni (MI)
Japan TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology Aichi
Japan Akaicho Clinic Chiba-shi, Chiba
Japan The Institute of Medical Science, Asahi Life Foundation Chuo-ku, Tokyo
Japan Naka Kinen Clinic Ibaraki
Japan Asano Clinic Kawagoe-shi Saitama, Japan
Japan Minami Akatsuka Clinic Mito-shi, Ibaraki
Japan Heiwadai Hospital Miyazaki-shi Miyazaki
Japan Takatsuki Red Cross Hospital Osaka
Japan Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology Shinjuku-ku, Tokyo
Japan Fukuwa Clinic Tokyo
Japan Tokyo-Eki Center-building Clinic Tokyo
Malaysia Klinik Kesihatan Simpang Kuala Alor Setar
Malaysia Hospital Universiti Kebangsaan Malaysia Cheras Kuala Lumpur
Malaysia Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan Kota Bharu Kelantan
Malaysia University Malaya Medical Centre Kuala Lumpur Wilayah Persekutuan Kuala Lumpur
Malaysia Miri Hospital Miri, Sarawak
Malaysia Hospital Seri Manjung Seri Manjung Perak
Malaysia University Technology MARA (UiTM) - Puncak Alam Sungai Buloh Selangor
Poland NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Malgorzata Arciszewska Bialystok Podlaskie
Poland SNZOZ Lege Artis Bialystok
Poland Centrum Medyczne Pratia Gdynia Gdynia Pomorskie
Poland Centrum Terapii Wspolczesnej Lodz
Poland Gabinet Lekarski Malgorzata Saryusz-Wolska Lodz
Poland NBR Polska Tomasz Klodawski Warszawa
Slovenia Healthcare centre Kocevje Kocevje
Slovenia Healthcare Centre Koper Koper
Slovenia UKC Ljubljana, Endocrinology and Diabetes Ljubljana
Slovenia General Hospital Murska Sobota Murska Sobota
Slovenia General Hospital Nova Gorica_Diabetes Nova Gorica
South Africa Medi-Clinic Bloemfontein Bloemfontein Free State
South Africa Spoke Research Inc Cape Town Western Cape
South Africa Lenasia Clinical Trial Centre Lenasia Gauteng
South Africa Prof P. Joshi Pretoria Gauteng
Thailand Rajavithi Hospital Bangkok
Thailand Siriraj Hospital_Bangkoknoi, Bangkok Bangkoknoi, Bangkok Bangkok
Thailand Maharaj Nakorn Chiang Mai Hospital Chiang Mai Mueang Chiang Mai District
Thailand Srinagarind Hospital Khon Kaen
Thailand Maharat Nakhon Ratchasima Hospital Nakhon Ratchasima
Turkey Baskent Universitesi Adana Adana
Turkey Gulhane Egitim Arastirma Hastanesi Ankara
Turkey Akdeniz University Tip Fakultesi Hastanesi Antalya
Turkey Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi Aydin
Turkey Pamukkale Universitesi Tip Fakultesi Denizli
Turkey TC SB Ist.Il Sag.Müd.Prof.Dr.Cemil Tascioglu Sehir Hastanesi Istanbul
Turkey Dokuz Eylul University Medical Faculty Izmir
United States Amarillo Med Spec LLP Amarillo Texas
United States AM Diabetes And Endocrinology Center Bartlett Tennessee
United States Northern Pines Hlth Ctr, PC Buckley Michigan
United States Diab & Endo Assoc of Stark Co Canton Ohio
United States Univ Diab & Endo Consultants Chattanooga Tennessee
United States Velocity Clinical Res-Dallas Dallas Texas
United States Creekside Endocrine Associates Denver Colorado
United States Northeast Research Institute Fleming Island Florida
United States Prestige Clinical Research Franklin Ohio
United States PlanIt Research, PLLC Houston Texas
United States Protenium Clinical Research Hurst Texas
United States MedStar Hlth Res Institute Hyattsville Maryland
United States Northeast Res Inst. Inc. Jacksonville Florida
United States Scripps Wht Diab Inst La Jolla La Jolla California
United States Milton Haber, M.D. Laredo Texas
United States Palm Research Center Inc-Vegas Las Vegas Nevada
United States The Research Group of Lexington LLC Lexington Kentucky
United States Downtown LA Res Ctr. Inc. Los Angeles California
United States South Broward Research LLC Miramar Florida
United States HealthStar Physicians PC Morristown Tennessee
United States Adult Medicine of Lake County, Inc. Mount Dora Florida
United States Saltzer Medical Group Research Nampa Idaho
United States Southern NH Diabetes and Endocrinology Nashua New Hampshire
United States Florida Inst For Clin Res Orlando Florida
United States Clinical Investigations Of Texas Plano Texas
United States Rainier Clin Res Ctr Inc Renton Washington
United States Endo Res Solutions Inc Roswell Georgia
United States Chrysalis Clinical Research Saint George Utah
United States Briggs Clinical Research, LLC San Antonio Texas
United States NE Clin Res of San Antonio San Antonio Texas
United States San Diego Family Care San Diego California
United States Hillcrest Clinical Research Simpsonville South Carolina
United States NorthShore Univ Hlth Sys Skokie Illinois
United States Piedmont Healthcare/Research Statesville North Carolina
United States Simcare Medical Research, LLC Sugar Land Texas
United States New Venture Medical Research Wadsworth Ohio
United States Iowa Diab & Endo Res Center West Des Moines Iowa
United States Southgate Medical Group, LLP West Seneca New York
United States Accellacare Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Czechia,  France,  Germany,  Hungary,  India,  Italy,  Japan,  Malaysia,  Poland,  Slovenia,  South Africa,  Thailand,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HbA1c Percent-points 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) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) Number of episodes From week 0 (V52) to week 52 (V54)
Secondary Time in range 3.9 - 10.0 mmol/L (70 - 180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 Percentage of readings From week 48 (V50) to week 52 (V54)
Secondary Time spent more than 10.0 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 Percentage of readings From week 48 (V50) to week 52 (V54)
Secondary Time spent less than 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 Percentage of readings From week 48 (V50) to week 52 (V54)
Secondary Change in fasting plasma glucose (FPG) mmol/L From baseline week 0 (V2) to week 52 (V54)
Secondary Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction Score 0-36. The higher the score the greater the satisfaction with treatment. From baseline week 0 (V2) to week 52 (V54)
Secondary Number of severe hypoglycaemic episodes (level 3) Number of episodes From baseline week 0 (V2) to week 57 (V56)
Secondary Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter) Number of episodes From baseline week 0 (V2) to week 57 (V56)
Secondary Weekly insulin dose (total) Units From week 50 (V52) to week 52 (V54)
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
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 NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
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