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
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT04770532
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 526
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin degludec Insulin degludec Insulin degludec + non-insulin anti-diabetic drugs. Pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which must be discontinued at randomisation. The background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period. Insulin icodec Insulin Icodec Insulin icodec + non-insulin anti-diabetic drugs. Pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which must be discontinued at randomisation. The background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period.
- Primary Outcome Measures
Name Time Method Change in Glycated Haemoglobin (HbA1c) Baseline (Week 0), Week 26 Change in HbA1c from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
- Secondary Outcome Measures
Name Time Method Change in Fasting Plasma Glucose (FPG) Baseline (Week 0), Week 26 Change in FPG from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
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 From week 22 to week 26 The percentage of time in target-range 3.9-10.0 mmol/L (70-180 milligrams per deciliter \[mg/dL\]) using continuous glucose monitoring (CGM) system is presented. Time in target range is defined as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction Baseline (Week 0), Week 26 Change in DTSQs in total treatment satisfaction from baseline (week 0) to week 26 is presented. The DTSQ domain score in total treatment satisfaction was calculated by adding the six item scores of items 1, 4-8. Higher scores indicate higher levels of treatment satisfaction for items 1, 4 -8. For items 2 and 3 a higher score indicates a participant perceived experience of hyperglycaemia and hypoglycaemia. Lower scores indicate a perception of blood glucose levels being unacceptably high (item 2) or low (item 3). The score has a minimum of 0 and a maximum of 36. The outcome data was evaluated based on in-trial observation period. In-trial observation period started at randomisation and ended at the date of: Last direct participant-site contact, withdrawal for participants who withdrew their informed consent, last participant-investigator contact as defined by the investigator for participants who were lost to follow-up and death for participants who died before any of the above.
Number of Severe Hypoglycaemic Episodes (Level 3) From baseline (week 0) to week 31 Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the on-treatment observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) From baseline (week 0) to week 31 Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by blood glucose (BG) meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the on-treatment observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product.
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) From baseline (week 0) to week 31 Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by blood glucose (BG) meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of \< 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the in-trial observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period.
Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System From week 22 to week 26 Percentage of tiime spent \< 3.0 millimoles per liter (mmol/L) (54 mg/dL) using continuous glucose monitoring (CGM) system is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
Percentage of Time Spent > 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System From week 22 to week 26 Percentage of time spent \> 10 millimoles per liter (mmol/L) (180 milligrams per deciliter \[mg/dL\]) using continuous glucose monitoring (CGM) system is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
Mean Weekly Insulin Dose From week 24 to week 26 Estimated mean weekly insulin dose during the last 2 weeks of treatment (from week 24 to week 26) is presented. The outcome data was evaluated based on the on-treatment observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product.
Change in Body Weight Baseline (Week 0), Week 26 Change in body weight from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
Trial Locations
- Locations (71)
Futata Tetsuhiro Clinic Meinohama
🇯🇵Fukuoka-shi, Fukuoka, Japan
Naka Kinen Clinic
🇯🇵Ibaraki, Japan
Yuri Ono Clinic
🇯🇵Sapporo-shi, Hokkaido, Japan
Oyama East Clinic
🇯🇵Tochigi, Japan
Juntendo University Hospital_Tokyo
🇯🇵Tokyo, Japan
Noritake Clinic
🇯🇵Ushiku-shi, Ibaraki, Japan
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Nowon Eulji Medical Center, Eulji University
🇰🇷Seoul, Korea, Republic of
Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A.
🇵🇱Lodz, Poland
NZOZ "DiabMed" Poradnia Diabetologiczna
🇵🇱Poznan, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
🇵🇱Warszawa, Poland
Unidade Local de Saúde de Matosinhos
🇵🇹Senhora Da Hora, Matosinhos, Matosinhos, Portugal
Hospital Garcia de Orta
🇵🇹Almada, Portugal
Centro Hospitalar Lisboa Ocidental
🇵🇹Lisboa, Portugal
Unidade Local de Saúde de Santo António, E.P.E
🇵🇹Porto, Portugal
Centro Hospitalar de São João
🇵🇹Porto, Portugal
Hospital da Luz Arrabida
🇵🇹Vila Nova de Gaia, Portugal
Greenacres Hospital
🇿🇦Port Elizabeth, Eastern Cape, South Africa
Medi-Clinic Bloemfontein
🇿🇦Bloemfontein, Free State, South Africa
Hemant Makan
🇿🇦Johannesburg, Gauteng, South Africa
Chris Hani Baragwanath Hospital
🇿🇦Johannesburg, Gauteng, South Africa
Centre for Diabetes
🇿🇦Johannesburg, Gauteng, South Africa
Dr A Amod
🇿🇦Durban, KwaZulu-Natal, South Africa
Clinic of Medical Academy, Dnipro
🇺🇦Dnipro, Ukraine
Department of Medical Service and Rehabilitation of "Artem"
🇺🇦Kyiv, Ukraine
Institute of Endocrinology and Metabolism of AMSU
🇺🇦Kyiv, Ukraine
Ternopil Central District Hospital
🇺🇦Ternopil, Ukraine
'Medical center Medi city 21' OOD
🇧🇬Kyustendil, Bulgaria
OCIPSOMCEMD ENDO MED-CONSULT - Dr. Nikolay Botushanov
🇧🇬Plovdiv, Bulgaria
ASOMCEM - IP - Dr. Antoanela Slavcheva
🇧🇬Ruse, Bulgaria
Milek, Hohenmölsen
🇩🇪Hohenmölsen, Germany
MMA-MHAT Sofia, Clinic of Endocrinology and Metab. Diseases
🇧🇬Sofia, Bulgaria
InnoDiab Forschung GmbH
🇩🇪Essen, Germany
Wendisch/Dahl Hamburg
🇩🇪Hamburg, Germany
Hillcrest Family Health Center
🇺🇸Waco, Texas, United States
Capital Clin Res Ctr,LLC
🇺🇸Olympia, Washington, United States
American Clinical Trials
🇺🇸Buena Park, California, United States
Valley Research
🇺🇸Fresno, California, United States
Scripps Whittier Diabetes Inst
🇺🇸La Jolla, California, United States
Clinical Trials Research_Sacramento
🇺🇸Lincoln, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Desert Oasis Hlthcr Med Group
🇺🇸Palm Springs, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
South Broward Research LLC
🇺🇸Miramar, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Endo Res Solutions Inc
🇺🇸Roswell, Georgia, United States
Velocity Clin. Res Valparaiso
🇺🇸Valparaiso, Indiana, United States
New Orleans Center for Clinical Research
🇺🇸New Orleans, Louisiana, United States
Ileana J Tandron APMC
🇺🇸Slidell, Louisiana, United States
Endo And Metab Cons
🇺🇸Rockville, Maryland, United States
MassResearch, LLC
🇺🇸Waltham, Massachusetts, United States
Albany Medical College - Endo
🇺🇸Albany, New York, United States
PharmQuest Life Sciences LLC
🇺🇸Greensboro, North Carolina, United States
Accellacare
🇺🇸Wilmington, North Carolina, United States
Amarillo Med Spec LLP
🇺🇸Amarillo, Texas, United States
Velocity Clinical Res-Dallas
🇺🇸Dallas, Texas, United States
Diabetes and Thyroid Ctr of FW
🇺🇸Fort Worth, Texas, United States
PlanIt Research, PLLC
🇺🇸Houston, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Simcare Medical Research, LLC
🇺🇸Sugar Land, Texas, United States
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
🇩🇪Münster, Germany
Wenzl-Bauer, Rehlingen-Siersb.
🇩🇪Rehlingen-Siersburg, Germany
Marienhospital Stuttgart - Innere Medizin 1
🇩🇪Stuttgart, Germany
Erlinger
🇩🇪Stuttgart, Germany
Hayashi Diabetes Clinic
🇯🇵Chigasaki-shi, Kanagawa, Japan, Japan
Heiwadai Hospital
🇯🇵Miyazaki-shi, Miyazaki, Japan
Tokuyama clinic
🇯🇵Chiba, Japan