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A Study Using Flash Glucose Measurements for a New Once-weekly Insulin (Insulin Icodec) in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 9) (ONWARDS 9)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Insulin Icodec
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study Age above or equal to 18 years at the time of signing informed consent Diagnosed with type 2 diabetes (T2D) greater than or equal to (>=) 180 days before screening HbA1c from 7.0%-11.0% (53.0-96.7 millimoles per mole [mmol/mol]) both inclusive at screening confirmed by central laboratory analysis Insulin-naïve. However, short term insulin treatment for a maximum of 14 consecutive days before screening is allowed, as is prior insulin treatment for gestational diabetes Stable daily dose(s) >=90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: Any metformin formulations >= 1500 milligrams (mg) or maximum tolerated or effective dose or Any metformin combination formulations >=1500 mg or maximum tolerated or effective dose or Other antidiabetic Drugs including combination products (>=half of the maximum approved dose according to local label or maximum tolerated or effective dose) of the classes specified below: Sulfonylureas, Meglitinides (glinides), Dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors, Thiazolidinedione, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs, Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists Intensification with basal insulin is indicated to achieve fasting glycaemic target (4.4-7.2 millimoles per liter [mmol/L]; 80-130 milligrams per deciliter [mg/dL]) at the discretion of the treating investigator Body mass index (BMI) less than or equal to (<=) 40.0 kilograms per meter square (kg/m^2) Exclusion Criteria: Unwilling or unable to avoid concomitant medication e.g., ascorbic acid (vitamin C) that can influence the flash glucose monitoring (FGM) sensor throughout the study and contraindications e.g., implanted medical devices such as pacemakers Any episodes of diabetic ketoacidosis within 90 days before screening as declared by the participant or in the medical records Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 180 days before the day of screening and between screening and initiation visits 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 90 days before the day of screening or in the period between screening and initiation visits. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insulin Icodec

Arm Description

Participants will receive 70 Units (U) insulin icodec subcutaneously once-weekly for 26 weeks.

Outcomes

Primary Outcome Measures

Change in glycated haemoglobin (HbA1c)
Measured in percentage (%)-point.

Secondary Outcome Measures

Full Information

First Posted
April 9, 2023
Last Updated
October 11, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05823948
Brief Title
A Study Using Flash Glucose Measurements for a New Once-weekly Insulin (Insulin Icodec) in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 9)
Acronym
ONWARDS 9
Official Title
A Study to Evaluate Flash Glucose Monitoring Based Titration of Once-weekly Insulin Icodec in Insulin-naïve Participants With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
October 13, 2023 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study looks at how a person with type 2 diabetes can be treated with insulin icodec and a flash glucose monitor (a small sensor inserted under the skin to measure blood sugar all the time). The study will look at how well insulin icodec controls blood sugar when used in combination with a flash glucose monitor. Participants will get insulin icodec that they have to inject once a week on the same day of the week. The insulin will be 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 to wear a flash glucose monitor throughout the study. This is a sensor that fits on arm. Participants will be asked to use a commercially available app called LibreView to allow team to view flash glucose monitor data. Participants will get a study phone to scan the flash glucose monitor 4 times daily and they will be able to see all of the flash glucose monitor data during the study. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Insulin Icodec
Arm Type
Experimental
Arm Description
Participants will receive 70 Units (U) insulin icodec subcutaneously once-weekly for 26 weeks.
Intervention Type
Drug
Intervention Name(s)
Insulin Icodec
Intervention Description
Participants will receive insulin icodec once-weekly subcutaneously into the thigh, upper arm or abdomen.
Primary Outcome Measure Information:
Title
Change in glycated haemoglobin (HbA1c)
Description
Measured in percentage (%)-point.
Time Frame
From initiation week 0 (Visit 3) to week 26 (Visit 26)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study Age above or equal to 18 years at the time of signing informed consent Diagnosed with type 2 diabetes (T2D) greater than or equal to (>=) 180 days before screening HbA1c from 7.0%-11.0% (53.0-96.7 millimoles per mole [mmol/mol]) both inclusive at screening confirmed by central laboratory analysis Insulin-naïve. However, short term insulin treatment for a maximum of 14 consecutive days before screening is allowed, as is prior insulin treatment for gestational diabetes Stable daily dose(s) >=90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: Any metformin formulations >= 1500 milligrams (mg) or maximum tolerated or effective dose or Any metformin combination formulations >=1500 mg or maximum tolerated or effective dose or Other antidiabetic Drugs including combination products (>=half of the maximum approved dose according to local label or maximum tolerated or effective dose) of the classes specified below: Sulfonylureas, Meglitinides (glinides), Dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors, Thiazolidinedione, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs, Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists Intensification with basal insulin is indicated to achieve fasting glycaemic target (4.4-7.2 millimoles per liter [mmol/L]; 80-130 milligrams per deciliter [mg/dL]) at the discretion of the treating investigator Body mass index (BMI) less than or equal to (<=) 40.0 kilograms per meter square (kg/m^2) Exclusion Criteria: Unwilling or unable to avoid concomitant medication e.g., ascorbic acid (vitamin C) that can influence the flash glucose monitoring (FGM) sensor throughout the study and contraindications e.g., implanted medical devices such as pacemakers Any episodes of diabetic ketoacidosis within 90 days before screening as declared by the participant or in the medical records Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 180 days before the day of screening and between screening and initiation visits 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 90 days before the day of screening or in the period between screening and initiation visits. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

A Study Using Flash Glucose Measurements for a New Once-weekly Insulin (Insulin Icodec) in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 9)

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