A Research Study to Compare Two Types of Insulin a New Insulin Insulin Icodec and an Available Insulin Insulin Degludec in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3)

  • STATUS
    Recruiting
  • End date
    Jun 21, 2022
  • participants needed
    774
  • sponsor
    Novo Nordisk A/S
Updated on 16 September 2021

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 get their study medicine in an injection pen. Participants will get a pen for weekly injection and one for daily injection. One will be icodec or degludec and the other will be dummy medicine. The treatment participants get is decided by chance. Participants and the study staff will not know which active medicine they get.

The insulin is injected with a needle in a skin fold in the thigh. The study could last for about 8 months. Participants will have 13 clinic visits and 17 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.

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

Details
Condition NIDDM, Diabetes Mellitus, Type 2, Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment insulin degludec, Insulin Icodec, Placebo insulin icodec, Placebo insulin degludec
Clinical Study IdentifierNCT04795531
SponsorNovo Nordisk A/S
Last Modified on16 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female aged above or equal to 18 years at the time of signing informed consent
Diagnosed with T2D (type 2 diabetes) greater than or equal to 180 days prior to the day of screening
HbA1c (glycated haemoglobin) from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis
Insulin nave. 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 anti-diabetic 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 oral anti-diabetic 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).:Sulfonylureas - Meglitinides
(glinides) - DPP-4 inhibitors - SGLT2 inhibitors - Thiazolidinediones - Alpha-
glucosidase inhibitors - Oral combination products (for the allowed individual
Oral Anti-diabetic Drugs (OADs)) - 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 (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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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