Clinical trial NCT06340854: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Diabetes, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-04-02
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in glycated hemoglobin (HbA1c)
timeFrame: From baseline (week 0) to week 26
Secondary outcomes:
measure: Change in time in range 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre (mg/dL))
timeFrame: From baseline (week -4 to 0) to week 22-26
measure: Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction
timeFrame: From baseline (week 0) to week 26
measure: Number of severe hypoglycaemic episodes (level 3)
timeFrame: From baseline (week 0) to week 31
measure: 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)
timeFrame: From baseline (week 0) to week 31
measure: 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)
timeFrame: From baseline (week 0) to week 31
measure: Time spent < 3.0 mmol/L (54 mg/dL)
timeFrame: From week 22 to 26
measure: Change in time spent > 10.0 mmol/L (180 mg/dL)
timeFrame: From baseline (week-4 to 0) to week 22-26
measure: Mean weekly insulin dose
timeFrame: From week 24 to week 26
measure: Change in body weight
timeFrame: From baseline (week 0) to week 26
Other outcomes:
Locations:
city: Hawthorne
country: United States
facility: Advanced Investigative Medicine, Inc.
state: California
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Inst
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Fleming Island
country: United States
facility: Northeast Research Institute of Florida
state: Florida
city: Miramar
country: United States
facility: South Broward Research LLC
state: Florida
city: Roswell
country: United States
facility: Endo Res Solutions Inc
state: Georgia
city: Topeka
country: United States
facility: Cotton-Oneill Diabetes and End
state: Kansas
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
city: Jefferson City
country: United States
facility: Jefferson City Medical Group, PC
state: Missouri
city: Omaha
country: United States
facility: Univ of Nebraska Medical CTR
state: Nebraska
city: Las Vegas
country: United States
facility: Palm Research Center Inc-Vegas
state: Nevada
city: Nashua
country: United States
facility: Southern NH Diabetes and Endo_Nashua
state: New Hampshire
city: Greensboro
country: United States
facility: PharmQuest Life Sciences LLC
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare Wilmington
state: North Carolina
city: Myrtle Beach
country: United States
facility: Trial Management Associates
state: South Carolina
city: Amarillo
country: United States
facility: Amarillo Medical Specialists
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Houston
country: United States
facility: Victorium Clinical Research
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Renton
country: United States
facility: Rainier Clin Res Ctr Inc
state: Washington
city: Dobrich
country: Bulgaria
facility: "Medical Center Viva Feniks" Ood
city: Sofia
country: Bulgaria
facility: MHAT "Knyaginya Klementina" -Sofia EAD
city: Sofia
country: Bulgaria
facility: UMHAT Aleksandrovska
city: Sofia
country: Bulgaria
facility: Medical Institute of Ministry of interior
city: Varna
country: Bulgaria
facility: Medical centre Clinic Nova
city: Yambol
country: Bulgaria
facility: Medical centre Berbatov Beli drin
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
city: Münster
country: Germany
facility: MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
city: Oldenburg in Holstein
country: Germany
facility: RED-Institut für medizinische Forschung und Fortbildung GmbH
city: Osnabrück
country: Germany
facility: Institut für Diabetesforschung Osnabrück
city: Wangen
country: Germany
facility: Zentrum für klinische Studien Allgäu Oberschwaben
city: Bangalore
country: India
facility: Lifecare Hospital and Research Centre
state: Karnataka
city: Belgaum
country: India
facility: Belgaum Diabetes Centre
state: Karnataka
city: Bengaluru
country: India
facility: Manipal Hospital, Old Airport Road, Bengaluru
state: Karnataka
city: Indore
country: India
facility: TOTALL Diabetes Hormone Institute
state: Madhya Pradesh
city: Mumbai
country: India
facility: Seth GS Medical College & KEM Hospital
state: Maharashtra
city: Pune
country: India
facility: Grant Medical Foundation Ruby Hall Clinic
state: Maharashtra
city: Pune
country: India
facility: Chellaram Diabetes Institute
state: Maharashtra
city: Hyderabad
country: India
facility: Malla Reddy Narayana Multispeciality Hospital
state: Telangana
city: Hyderabad
country: India
facility: Gandhi Hospital & Medical college
state: Telengana
city: Noida
country: India
facility: Government Institute of Medical Sciences
state: Uttar Pradesh
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
city: Ludhiana
country: India
facility: Christian Medical College and Hospital
city: Puducherry
country: India
facility: Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
city: Miyazaki-shi
country: Japan
facility: Heiwadai Hospital
state: Miyazaki
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical Univ. Hospital_Diabetes, Metabolism and Endocrinology
state: Tokyo
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Futata Tetsuhiro Clinic Meinohama
city: Tochigi
country: Japan
facility: Oyama East Clinic
city: Ushiku-shi, Ibaraki
country: Japan
facility: Noritake Clinic
city: Opole
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Opolu
state: Opolskie
city: Bialystok
country: Poland
facility: NZOZ Vita-Diabetica Malgorzata Buraczyk
state: Podlaskie Voivodeship
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
state: Podlaskie
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia
state: Pomorskie
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
city: Piotrków Trybunalski
country: Poland
facility: Trialmed CRS
state: Łódzkie
city: Bayamon
country: Puerto Rico
facility: Advanced Clinical Research LLC
city: Manati
country: Puerto Rico
facility: Manati Ctr For Clin Research
city: Johannesburg
country: South Africa
facility: Hemant Makan
state: Gauteng
city: Lenasia
country: South Africa
facility: Dr Moosa's Rooms
state: Gauteng
city: Pretoria
country: South Africa
facility: Botho ke Bontle Health Services
state: Gauteng
city: Durban
country: South Africa
facility: Dr Mahesh Duki Research And Trial Site
state: KwaZulu Natal
city: Durban
country: South Africa
facility: Dr A Amod
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Dr MB Moosa's Practice
state: KwaZulu-Natal
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: La Roca del Vallés
country: Spain
facility: ABS La Roca del Vallés
city: Málaga
country: Spain
facility: Hospital Clínico Virgen de la Victoria
city: Pozuelo de Alarcón
country: Spain
facility: Hospital Quirón
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: