A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 5)

• ClinicalTrials.gov Identifier: NCT04760626
• Recruitment Status: Completed
• First Posted: February 18, 2021
• Last Update Posted: August 15, 2023
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Tracking Information

• First Submitted Date: February 17, 2021
• First Posted Date: February 18, 2021
• Last Update Posted Date: August 15, 2023
• Actual Study Start Date: March 1, 2021
• Actual Primary Completion Date: August 12, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 17, 2021)

Change in HbA1c (glycated haemoglobin) [ Time Frame: From baseline week 0 (V2) to week 52 (V6) ]

%-point

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 17, 2021)

• Time from baseline to treatment discontinuation or intensification [ Time Frame: From baseline week 0 (V2) to week 52 (V6) ]
  Days
• Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction [ Time Frame: From baseline week 0 (V2) to week 52 (V6) ]
  Score of 0-36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment.
• Trim-D (Treatment Related Impact Measure for Diabetes) compliance domain [ Time Frame: At end of treatment week 52 (V6) ]
  Score of 4-20. 4 items scored on a scale of 1 to 5 Transformed to a 0-100 scale with higher scores corresponding to better compliance.
• Number of severe hypoglycaemic episodes (level 3) [ Time Frame: From baseline week 0 (V2) to week 57 (V8) ]
  Number of episodes
• 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 (V2) to week 57 (V8) ]
  Number of episodes
• 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 (V2) to week 57 (V8) ]
  Number of episodes

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before
• Official Title: Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting

Brief Summary

This study compares insulin icodec to different daily insulins in people with type 2 diabetes.

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

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

Participants will measure their blood sugar every day. Participants will get a study phone to record safety data in the electronic diary (eDiary). If participants get a daily insulin they will record their insulin doses in the eDiary. If Participants get weekly insulin icodec, participants study phone will also have the DoseGuide App. The DoseGuide App gives dose recommendations based on their blood sugar and previous doses. Participants will record their insulin doses in the DoseGuide App.

The study will last for about 1 year and 2 months. Participants will have 8 planned clinic visits with the study doctor. More visits will be planned to meet individual needs. At 6 clinic visits participants will have blood samples taken.

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

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Diabetes Mellitus, Type 2

Intervention

• Drug: Insulin icodec
  Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 52 weeks.
• Drug: Insulin Glargine 100U/mL
  Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
• Drug: Insulin Degludec
  Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
• Drug: Insulin Glargine 300U/mL
  Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.

Study Arms

• Experimental: Insulin icodec with DoseGuide
  Participants randomised to insulin icodec will use insulin icodec with the DoseGuide App to guide their titration.
  Intervention: Drug: Insulin icodec
• Active Comparator: Once daily basal insulin analogues
  Participants randomised to basal insulin analogue injections once daily
  Interventions:

  • Drug: Insulin Glargine 100U/mL
  • Drug: Insulin Degludec
  • Drug: Insulin Glargine 300U/mL

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 29, 2021): 1085
• Original Estimated Enrollment (submitted: February 17, 2021): 1096
• Actual Study Completion Date: August 29, 2022
• Actual Primary Completion Date: August 12, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
• Male or female.
• Age 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 above 7.0% (53 mmol/mol) as measured by central lab.
• Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
• Stable daily dose(s) greater than or equal to 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regimen(s): a .Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. b .Any metformin combination formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. c. Any of the following non-insulin antidiabetic drug classes including combinations (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose):i). Sulfonylureas ii). Meglitinides (glinides) iii). DPP-4 inhibitors iv. SGLT2 inhibitors v). Thiazolidinediones vi). Alpha-glucosidase inhibitors vii). Oral combination products (for the allowed individual Oral Antidiabetic Drugs (OADs)) viii). Oral or injectable GLP-1-receptor agonists
• Intensification with insulin is indicated to achieve glycaemic target (4.4-7.2 mmol/L, 80-130 mg/dL) at the discretion of the treating investigator.

Exclusion Criteria:

• Known or suspected hypersensitivity to trial product(s) or related products.
• Previous participation in this trial. Participation is defined as signed informed consent.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening)
• Any disorder which in the investigator's opinion might jeopardise subject's safety

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Germany, Greece, Hungary, Poland, Puerto Rico, Turkey, United States
• Removed Location Countries: Serbia

Administrative Information

• NCT Number: NCT04760626
• Other Study ID Numbers: NN1436-4481; U1111-1247-5279 ( Other Identifier: World Health Organization (WHO) ); 2020-000476-38 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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

• Current Responsible Party: Novo Nordisk A/S
• Original Responsible Party: Same as current
• Current Study Sponsor: Novo Nordisk A/S
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Transparency (dept. 1452); Novo Nordisk A/S

• PRS Account: Novo Nordisk A/S
• Verification Date: July 2023