Clinical trial NCT04770532: A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin
Official title: A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec, Both With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes Treated With Basal Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-02-25
Enrollment: 526
Sex: ALL
Standard ages: CHILD
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 degludec (an insulin taken once daily which is already available on the market) in people with type 2 diabetes.

The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided by chance.

The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.

The study will last for about 8 months. Participants will have 17 clinic visits and 13 phone calls with the study doctor. At 8 clinic visits participants will have blood samples taken. At 4 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.

Participants will be asked to wear a sensor that measures their blood sugar all the time in 3 periods for a total of 13 weeks (about 3 months) during the study.

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility criteria: Inclusion Criteria:

* Male or female aged above or equal to 18 years at the time of signing informed consent.
* Diagnosed with T2D greater than or 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 units/mL, or insulin glargine 300 units/mL): greater than or equal to 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to screening:

  * Metformin
  * Sulfonylureas
  * Meglitinides (glinides)
  * DPP-4 inhibitors
  * SGLT2 inhibitors
  * Thiazolidinediones
  * Alpha-glucosidase inhibitors
  * Oral combination products (for the allowed individual oral anti-diabetic drugs)
  * Oral or injectable GLP-1-receptor agonists
* Body mass index (BMI) below or equal to 40.0 kg/m\^2.

Exclusion Criteria:

* Any episodes (as declared by the subject or in the medical records) 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 Haemoglobin (HbA1c)
timeFrame: Baseline (Week 0), Week 26
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Baseline (Week 0), Week 26
measure: Percentage of Time in Target-range 3.9-10.0 Millimoles Per Liter (mmol/L) (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System
timeFrame: From week 22 to week 26
measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction
timeFrame: Baseline (Week 0), 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) (<3.0 mmol/L (54 mg/dL), Confirmed by 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: Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System
timeFrame: From week 22 to week 26
measure: Percentage of Time Spent > 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System
timeFrame: From week 22 to week 26
measure: Mean Weekly Insulin Dose
timeFrame: From week 24 to week 26
measure: Change in Body Weight
timeFrame: Baseline (Week 0), Week 26
Other outcomes:
Locations:
city: Buena Park
country: United States
facility: American Clinical Trials
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Inst
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research_Sacramento
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Hlthcr Med Group
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Miramar
country: United States
facility: South Broward Research LLC
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Roswell
country: United States
facility: Endo Res Solutions Inc
state: Georgia
city: Valparaiso
country: United States
facility: Velocity Clin. Res Valparaiso
state: Indiana
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Slidell
country: United States
facility: Ileana J Tandron APMC
state: Louisiana
city: Rockville
country: United States
facility: Endo And Metab Cons
state: Maryland
city: Waltham
country: United States
facility: MassResearch, LLC
state: Massachusetts
city: Albany
country: United States
facility: Albany Medical College - Endo
state: New York
city: Greensboro
country: United States
facility: PharmQuest Life Sciences LLC
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Amarillo
country: United States
facility: Amarillo Med Spec LLP
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Fort Worth
country: United States
facility: Diabetes and Thyroid Ctr of FW
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Sugar Land
country: United States
facility: Simcare Medical Research, LLC
state: Texas
city: Waco
country: United States
facility: Hillcrest Family Health Center
state: Texas
city: Olympia
country: United States
facility: Capital Clin Res Ctr,LLC
state: Washington
city: Kyustendil
country: Bulgaria
facility: 'Medical center Medi city 21' OOD
city: Plovdiv
country: Bulgaria
facility: OCIPSOMCEMD ENDO MED-CONSULT - Dr. Nikolay Botushanov
city: Ruse
country: Bulgaria
facility: ASOMCEM - IP - Dr. Antoanela Slavcheva
city: Sofia
country: Bulgaria
facility: MMA-MHAT Sofia, Clinic of Endocrinology and Metab. Diseases
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
city: Hamburg
country: Germany
facility: Wendisch/Dahl Hamburg
city: Hohenmölsen
country: Germany
facility: Milek, Hohenmölsen
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
city: Rehlingen-Siersburg
country: Germany
facility: Wenzl-Bauer, Rehlingen-Siersb.
city: Stuttgart
country: Germany
facility: Marienhospital Stuttgart - Innere Medizin 1
city: Stuttgart
country: Germany
facility: Erlinger
city: Chigasaki-shi
country: Japan
facility: Hayashi Diabetes Clinic
state: Kanagawa, Japan
city: Miyazaki-shi
country: Japan
facility: Heiwadai Hospital
state: Miyazaki
city: Chiba
country: Japan
facility: Tokuyama clinic
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Futata Tetsuhiro Clinic Meinohama
city: Ibaraki
country: Japan
facility: Naka Kinen Clinic
city: Sapporo-shi, Hokkaido
country: Japan
facility: Yuri Ono Clinic
city: Tochigi
country: Japan
facility: Oyama East Clinic
city: Tokyo
country: Japan
facility: Juntendo University Hospital_Tokyo
city: Ushiku-shi, Ibaraki
country: Japan
facility: Noritake Clinic
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Lodz
country: Poland
facility: Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A.
city: Poznan
country: Poland
facility: NZOZ "DiabMed" Poradnia Diabetologiczna
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
city: Senhora Da Hora, Matosinhos
country: Portugal
facility: Unidade Local de Saúde de Matosinhos
state: Matosinhos
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Ocidental
city: Porto
country: Portugal
facility: Unidade Local de Saúde de Santo António, E.P.E
city: Porto
country: Portugal
facility: Centro Hospitalar de São João
city: Vila Nova de Gaia
country: Portugal
facility: Hospital da Luz Arrabida
city: Port Elizabeth
country: South Africa
facility: Greenacres Hospital
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: Medi-Clinic Bloemfontein
state: Free State
city: Johannesburg
country: South Africa
facility: Hemant Makan
state: Gauteng
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Hospital
state: Gauteng
city: Johannesburg
country: South Africa
facility: Centre for Diabetes
state: Gauteng
city: Durban
country: South Africa
facility: Dr A Amod
state: KwaZulu-Natal
city: Dnipro
country: Ukraine
facility: Clinic of Medical Academy, Dnipro
city: Kyiv
country: Ukraine
facility: Department of Medical Service and Rehabilitation of "Artem"
city: Kyiv
country: Ukraine
facility: Institute of Endocrinology and Metabolism of AMSU
city: Ternopil
country: Ukraine
facility: Ternopil Central District Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References:
citation: Philis-Tsimikas A, Bajaj HS, Begtrup K, Cailleteau R, Gowda A, Lingvay I, Mathieu C, Russell-Jones D, Rosenstock J. Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab. 2023 Feb;25(2):331-341. doi: 10.1111/dom.14871. Epub 2022 Oct 14.
citation: Philis-Tsimikas A, Asong M, Franek E, Jia T, Rosenstock J, Stachlewska K, Watada H, Kellerer M. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023 Jun;11(6):414-425. doi: 10.1016/S2213-8587(23)00093-1. Epub 2023 May 3.