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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06340854
Other study ID # NN1436-7724
Secondary ID U1111-1292-61512
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 19, 2024
Est. completion date June 20, 2025

Study information

Verified date May 2024
Source Novo Nordisk A/S
Contact Novo Nordisk
Phone (+1) 866-867-7178
Email clinicaltrials@novonordisk.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 404
Est. completion date June 20, 2025
Est. primary completion date May 16, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosed with T2D greater than equal to (=) 180 days prior to the day of screening. - HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol), both inclusive, at screening confirmed by central laboratory analysis. - Treated with once-daily or twice-daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 U/mL, or insulin glargine 300 U/mL) = 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than equal to (=) 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), Dipeptidyl peptidase 4 (DPP-4) inhibitors, Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors, thiazolidinediones, alphaglucosidase inhibitors, oral combination products (for the allowed individual oral anti- diabetic drugs), oral or injectable glucagon-like peptide 1 receptor agonists (GLP-1 RAs), injectable glucagon-like peptide 1(GLP-1)/ glucose-dependent insulinotropic polypeptide receptor agonist (GIP RA) combination products. - Body mass index (BMI) = 40.0 kilogram per square meter (kg/m^2). Exclusion Criteria: - Any episodes 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


Intervention

Drug:
Insulin icodec
Insulin Icodec will be administered subcutaneously.
Insulin glargine
Insulin glargine will be administered subcutaneously.

Locations

Country Name City State
Bulgaria "Medical Center Viva Feniks" Ood Dobrich
Bulgaria Medical Institute of Ministry of interior Sofia
Bulgaria MHAT "Knyaginya Klementina" -Sofia EAD Sofia
Bulgaria UMHAT Aleksandrovska Sofia
Germany InnoDiab Forschung GmbH Essen
Germany Institut für Diabetesforschung GmbH Münster - Dr. med. Rose Münster
Germany MedicalCenter am Clemenshospital Münster
Germany RED-Institut für medizinische Forschung und Fortbildung GmbH Oldenburg in Holstein
Germany Institut für Diabetesforschung Osnabrück Osnabrück
Germany Zentrum für klinische Studien Allgäu Oberschwaben Wangen
India Lifecare Hospital and Research Centre Bangalore Karnataka
India Belgaum Diabetes Centre Belgaum Karnataka
India Manipal Hospital, Old Airport Road, Bengaluru Bengaluru Karnataka
India Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh Chandigarh
India Gandhi Hospital & Medical college Hyderabad Telengana
India Malla Reddy Narayana Multispeciality Hospital Hyderabad Telangana
India Amrita Institute Of Medical Sciences & Research Centre Kochi Kerala
India Christian Medical College and Hospital Ludhiana
India Seth GS Medical College & KEM Hospital Mumbai Maharashtra
India Government Institute of Medical Sciences Noida Uttar Pradesh
India Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Puducherry
India Grant Medical Foundation Ruby Hall Clinic Pune Maharashtra
Japan Futata Tetsuhiro Clinic Meinohama Fukuoka-shi, Fukuoka
Japan Heiwadai Hospital Miyazaki-shi Miyazaki
Japan Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology Shinjuku-ku Tokyo
Japan Oyama East Clinic Tochigi
Japan Noritake Clinic Ushiku-shi, Ibaraki
Poland NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Malgorzata Arciszewska Bialystok Podlaskie
Poland NZOZ Vita-Diabetica Malgorzata Buraczyk Bialystok Podlaskie Voivodeship
Poland NZOZ Vita-Diabetica Malgorzata Buraczyk Bialystok Podlaskie Voivodeship
Poland Centrum Medyczne Pratia Gdynia Gdynia Pomorskie
Poland Centrum Medyczne Pratia Gdynia Gdynia Pomorskie
Poland Centrum Medyczne Pratia Katowice Katowice
Poland Centrum Medyczne Pratia Katowice Katowice
Poland Uniwersytecki Szpital Kliniczny w Opolu Opole Opolskie
Poland Uniwersytecki Szpital Kliniczny w Opolu Opole Opolskie
Poland Trialmed CRS Piotrków Trybunalski Lódzkie
Poland Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji Warszawa
Poland Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji Warszawa
Puerto Rico Advanced Clinical Research LLC Bayamon
Puerto Rico Manati Ctr For Clin Research Manati
South Africa Dr A Amod Durban KwaZulu-Natal
South Africa Dr Mahesh Duki Research And Trial Site Durban KwaZulu Natal
South Africa Dr MB Moosa's Practice Durban KwaZulu-Natal
South Africa Hemant Makan Johannesburg Gauteng
South Africa Dr Moosa's Rooms Lenasia Gauteng
South Africa Botho ke Bontle Health Services Pretoria Gauteng
Spain Hospital Clinic i Provincial Barcelona
Spain Hospital de Basurto Bilbao Vizcaya
Spain ABS La Roca del Vallés La Roca del Vallés
Spain Hospital Clínico Virgen de la Victoria Málaga
Spain Hospital Quirón Pozuelo de Alarcón
United States Amarillo Medical Specialists Amarillo Texas
United States Velocity Clinical Res-Dallas Dallas Texas
United States Northeast Research Institute of Florida Fleming Island Florida
United States PharmQuest Life Sciences LLC Greensboro North Carolina
United States Advanced Investigative Medicine, Inc. Hawthorne California
United States PlanIt Research, PLLC Houston Texas
United States Victorium Clinical Research Houston Texas
United States Jefferson City Medical Group, PC Jefferson City Missouri
United States Scripps Whittier Diabetes Inst La Jolla California
United States Palm Research Center Inc-Vegas Las Vegas Nevada
United States Clinical Trials Research Lincoln California
United States International Diabetes Center Minneapolis Minnesota
United States South Broward Research LLC Miramar Florida
United States Trial Management Associates Myrtle Beach South Carolina
United States Southern NH Diabetes and Endo_Nashua Nashua New Hampshire
United States Univ of Nebraska Medical CTR Omaha Nebraska
United States Univ of Nebraska Medical CTR Omaha Nebraska
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 Cotton-Oneill Diabetes and End Topeka Kansas
United States Accellacare Wilmington Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Bulgaria,  Germany,  India,  Japan,  Poland,  Puerto Rico,  South Africa,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in glycated hemoglobin (HbA1c) Percentage point (%-point). From baseline (week 0) to week 26
Secondary Change in time in range 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre (mg/dL)) Percentage (%) of time. From baseline (week -4 to 0) to week 22-26
Secondary Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction DTSQs measures the satisfaction with diabetes treatment regimens in people with diabetes. The measure consists of 8 items, of which 6 items contributes to 1 global score. Higher scores on the global score indicate greater satisfaction with treatment. Global score ranges 0- 36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment. From baseline (week 0) to week 26
Secondary Number of severe hypoglycaemic episodes (level 3) Number of episodes. From baseline (week 0) to week 31
Secondary Number of clinically significant hypoglycaemic episodes (level 2) (less than (<) 3.0 millimoles per litre (mmol/L) (54 mg/dL), confirmed by blood glucose (BG) meter) Number of episodes. From baseline (week 0) to week 31
Secondary 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) Number of episodes. From baseline (week 0) to week 31
Secondary Time spent < 3.0 mmol/L (54 mg/dL) % of time. From week 22 to 26
Secondary Change in time spent > 10.0 mmol/L (180 mg/dL) % of time. From baseline (week-4 to 0) to week 22-26
Secondary Mean weekly insulin dose Units (U). From week 24 to week 26
Secondary Change in body weight Kilogram (kg). From baseline (week 0) to week 26
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