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A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6) (ONWARDS 6)

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ClinicalTrials.gov Identifier: NCT04848480
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:

This study compares insulin icodec (a new insulin) to insulin degludec (an insulin already available on the market) in people with type 1 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 at random. Participants will also get a mealtime insulin.

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

The study will last for about 1 year and 2 months. Participants will have 28 clinic visits and 28 phone calls with the study doctor. At 11 clinic visits participants will have blood samples taken.

At 6 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 your blood sugar all the time. Participants will be asked to wear it for a total of 57 weeks (around 1 year).

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


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: insulin icodec Drug: insulin degludec Drug: insulin aspart Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes. A 26-week, Randomised, Multicentre, Open-label, Active-controlled, Parallel Group, Two Armed, Treat-to-target Trial Investigating the Effect on Glycaemic Control and Safety of Treatment With Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec, Both in Combination With Insulin Aspart in Adults With Type 1 Diabetes, With a 26-week Extension Investigating Long Term Safety
Actual Study Start Date : April 30, 2021
Estimated Primary Completion Date : May 12, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Insulin icodec + insulin aspart
insulin icodec once a week in combination with 2-4 times daily injections of insulin aspart at meal times
 Drug: insulin icodec
insulin icodec 700 units/mL, subcutaneously (under the skin), solution for injection once weekly

Drug: insulin aspart
insulin aspart 100 units/mL, subcutaneously (under the skin), solution for injection daily
Active Comparator: Insulin degludec + insulin aspart
insulin degludec once a day in combination with 2-4 times daily injections of insulin aspart at meal times
 Drug: insulin degludec
insulin degludec 100 units/mL, subcutaneously (under the skin), solution for injection once daily

Drug: insulin aspart
insulin aspart 100 units/mL, subcutaneously (under the skin), solution for injection daily


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c (glycated haemoglobin) [ Time Frame: From baseline (week 0) to week 26 ]
    %-point


Secondary Outcome Measures :
  1. Change in fasting plasma glucose (FPG) [ Time Frame: From baseline (week 0) to week 26 ]
    mmol/L

  2. Time in range 3.9-10.0 mmol/L (70-180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 [ Time Frame: From week 22 to week 26 ]
    % of readings

  3. Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction [ Time Frame: From baseline (week 0) to week 26 ]
    Score 0-36 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment

  4. Change in HbA1c [ Time Frame: From baseline (week 0) to week 52 ]
    %-point

  5. Number of severe hypoglycaemic episodes (level 3) [ Time Frame: From baseline (week 0) to week 26 ]
    Number of episodes

  6. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) [ Time Frame: From baseline (week 0) to week 26 ]
    Number of episodes

  7. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) [ Time Frame: From baseline (week 0) to week 26 ]
    Number of episodes

  8. Number of severe hypoglycaemic episodes (level 3) [ Time Frame: From baseline (week 0) to week 57 ]
    Number of episodes

  9. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) [ Time Frame: From baseline (week 0) to week 57 ]
    Number of episodes

  10. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) [ Time Frame: From baseline (week 0) to week 57 ]
    Number of episodes

  11. Number of nocturnal clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) [ Time Frame: From baseline (week 0) to week 26 ]
    Number of episodes

  12. Number of nocturnal clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) [ Time Frame: From baseline (week 0) to week 57 ]
    Number of episodes

  13. Time spent below 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 [ Time Frame: From week 22 to week 26 ]
    % of readings

  14. Time spent greater than 10 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 [ Time Frame: From week 22 to week 26 ]
    % of readings

  15. Mean total weekly insulin dose [ Time Frame: From week 24 to week 26 ]
    U

  16. Mean total weekly insulin dose [ Time Frame: From week 50 to week 52 ]
    U

  17. Change in body weight [ Time Frame: From baseline (week 0) to week 26 ]
    kg


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged greater than or equal to 18 years at the time of signing informed consent.
  • Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening.
  • Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) greater than or equal to 1 year prior to the day of screening.
  • HbA1c below10% at screening visit based on analysis from central laboratory.

Exclusion Criteria:

  • Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
  • Chronic heart failure classified as New York Heart Association (NYHA) 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04848480


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04848480    
Other Study ID Numbers: NN1436-4625
U1111-1251-7315 ( Other Identifier: World Health Organization (WHO) )
2020-002374-27 ( EudraCT Number )
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs