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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) (ONWARDS 3)

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ClinicalTrials.gov Identifier: NCT04795531
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
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 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin icodec Drug: Placebo insulin icodec Drug: Insulin degludec Drug: Placebo insulin degludec Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 774 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, in Insulin naïve Subjects With Type 2 Diabetes.
Actual Study Start Date : March 24, 2021
Estimated Primary Completion Date : May 17, 2022
Estimated Study Completion Date : June 21, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Once weekly insulin icodec + once daily placebo
Participants will get once daily and once weekly injections
Drug: Insulin icodec

You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo.

Subcutaneously (under the skin) injections


Drug: Placebo insulin degludec

You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo.

Subcutaneously (under the skin) injections


Experimental: Once weekly placebo and once daily insulin degludec
Participants will get once daily and once weekly injections
Drug: Placebo insulin icodec

You will get a pen for weekly injection and one for daily injection. One will be insulin degludec 100 units/mL and the other will be placebo.

Subcutaneously (under the skin) injections


Drug: Insulin degludec

You will get a pen for weekly injection and one for daily injection. One will be degludec 100 units/mL and the other will be placebo.

Subcutaneously (under the skin) injections





Primary Outcome Measures :
  1. Change in HbA1c (glycated haemoglobin) [ Time Frame: From baseline week 0 (V2) to week 26 (V28) ]
    %-point


Secondary Outcome Measures :
  1. Change in fasting plasma glucose (FPG) [ Time Frame: From baseline week 0 (V2) to week 26 (V28) ]
    mmol/L

  2. Number of severe hypoglycaemic episodes (level 3) [ Time Frame: From baseline week 0 (V2) to week 31 (V30) ]
    Number of episodes

  3. 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 31 (V30) ]
    Number of episodes

  4. 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 31 (V30) ]
    Number of episodes

  5. Number of severe hypoglycaemic episodes (level 3) [ Time Frame: From baseline week 0 (V2) to week 26 (V28) ]
    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 (V2) to week 26 (V28) ]
    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 (V2) to week 26 (V28) ]
    Number of episodes

  8. Change in body weight [ Time Frame: From baseline week 0 (V2) to week 26 (V28) ]
    Kg

  9. Mean weekly insulin dose [ Time Frame: From week 24 (P26) to week 26 (V28) ]
    U



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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 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 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.

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): NCT04795531


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 (dept. 1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04795531    
Other Study ID Numbers: NN1436-4479
U1111-1247-5218 ( Other Identifier: World Health Organization (WHO) )
2020-000472-37 ( EudraCT Number )
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021
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 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs