A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes

Diabetes, Type 2 Clinical Trial

Official title:

A Study to Evaluate the Efficacy and Safety of Once-weekly Insulin Icodec When Switching From Daily Basal Insulins Compared to Once-daily Insulin Glargine U100 in Adults With Type 2 Diabetes

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
• Start date: April 19, 2024
• Est. completion date: June 20, 2025

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Type 2

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 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	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