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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)

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

insulin icodec

insulin degludec

insulin aspart

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

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

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin icodec + insulin aspart

Insulin degludec + insulin aspart

Arm Description

insulin icodec once a week in combination with 2-4 times daily injections of insulin aspart at meal times.

insulin degludec once a day in combination with 2-4 times daily injections of insulin aspart at meal times.

Outcomes

Primary Outcome Measures

Change in Glycosylated Haemoglobin (HbA1c) at Week 26

Change in HbA1c from baseline to week 26 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation and ended at the date of: the last direct participant-site contact; withdrawal for participants who withdrew their informed consent; the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e. possibly an unscheduled phone visit); death for participants who died before any of the above.

Secondary Outcome Measures

Change in Glycosylated Haemoglobin (HbA1c) at Week 52

Change in HbA1c from baseline to week 52 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation and ended at the date of: the last direct participant-site contact; withdrawal for participants who withdrew their informed consent; the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e. possibly an unscheduled phone visit); death for participants who died before any of the above.

Change in Fasting Plasma Glucose (FPG)

Change in FPG from baseline to week 26 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation and ended at the date of: the last direct participant-site contact; withdrawal for participants who withdrew their informed consent; the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e. possibly an unscheduled phone visit); death for participants who died before any of the above.

Percentage of Time in Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System

Percentage of time in range 3.9-10.0 mmol/L (70-180 mg/dL) using CGM system from week 22 to week 26 is presented. Time in range is defined as 100 times the number of recorded measurements in glycaemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. Data is reported for 'in-trial' period. In-trial observation period started at randomisation and ended at the date of: the last direct participant-site contact; withdrawal for participants who withdrew their informed consent; the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e. possibly an unscheduled phone visit); death for participants who died before any of the above.

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction

Change in DTSQs in total treatment satisfaction from baseline to week 26 is presented. The sum score for DTSQ in total treatment satisfaction was calculated by adding the six item scores of items 1, 4, 5, 6, 7 and 8. The sum score for DTSQ can range from 0 to 36, with 0 being the lowest and 36 being the highest score in total treatment satisfaction. Higher scores on the DTSQ total score indicate higher treatment satisfaction. Data is reported for 'in-trial' period. In-trial observation period started at randomisation and ended at the date of: the last direct participant-site contact; withdrawal for participants who withdrew their informed consent; the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e. possibly an unscheduled phone visit); death for participants who died before any of the above.

Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26

Number of severe hypoglycaemic episodes (level 3) from baseline to week 26 are presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'main-on-treatment' period. The main-on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: the end date of the on-treatment period; week 26. On-treatment: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit, the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.

Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57

Number of severe hypoglycaemic episodes (level 3) from baseline to week 57 are presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'on-treatment' period. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL) Confirmed by Blood Glucose [BG] Meter): From Baseline (Week 0) to Week 26

Number of clinically significant hypoglycaemic episodes (level 2) from baseline to week 26 are presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Data is reported for 'main-on-treatment' period. The main-on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: the end date of the on-treatment period; week 26. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL) Confirmed by BG Meter): From Baseline (Week 0) to Week 57

Number of clinically significant hypoglycaemic episodes (level 2) from baseline to week 57 are presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Data is reported for 'on-treatment' period. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26

Number of clinically significant hypoglycaemic episodes (level 2) or severe hypoglycaemic episodes (level 3) from baseline to week 26 are presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'main-on-treatment' period. The main-on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: the end date of the on-treatment period; week 26. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.

Number of clinically significant hypoglycaemic episodes (level 2) or severe hypoglycaemic episodes (level 3) from baseline to week 57 are presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'on-treatment' period. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.

Number of Nocturnal Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26

Number of nocturnal clinically significant hypoglycaemic episodes (level 2) or severe hypoglycaemic episodes (level 3) from baseline to week 26 are presented. Nocturnal: The period between 00:01 and 05:59 (both included). Clinically significant hypoglycaemia (level 2): Plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3): Hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'main-on-treatment' period. The main-on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: the end date of the on-treatment period; week 26. On-treatment period: Onset date on or after first dose of trial product and no later than first date of either follow-up visit, last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for in-trial period.

Number of nocturnal clinically significant hypoglycaemic episodes (level 2) or severe hypoglycaemic episodes (level 3) from baseline to week 57 are presented. Nocturnal: The period between 00:01 and 05:59 (both included). Clinically significant hypoglycaemia (level 2): Plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3): Hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Data is reported for 'on-treatment' period. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.

Percentage of Time spent Less Than (<) 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System

Percentage of time spent < 3.0 mmol/L using CGM system from week 22 to week 26 is presented. Time spent below threshold (< 3.0 mmol/L [54 mg/dL]) was defined as 100 times the number of recorded measurements below the threshold, divided by the total number of recorded measurements. Data is reported for 'in-trial' period. In-trial observation period started at randomisation and ended at the date of: the last direct participant-site contact; withdrawal for participants who withdrew their informed consent; the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e. possibly an unscheduled phone visit); death for participants who died before any of the above.

Percentage of Time spent Greater Than (>) 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System

Percentage of time spent > 10 mmol/L using CGM system from week 22 to week 26 is presented. Time spent above threshold (> 10 mmol/L [180 mg/dL]) was defined as 100 times the number of recorded measurements above the threshold, divided by the total number of recorded measurements. Data is reported for 'in-trial' period. In-trial observation period started at randomisation and ended at the date of: the last direct participant-site contact; withdrawal for participants who withdrew their informed consent; the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e. possibly an unscheduled phone visit); death for participants who died before any of the above.

Mean Total Weekly Insulin Dose: From Week 24 to Week 26

Mean total weekly insulin dose from week 24 to week 26 is presented. Data is reported for 'main-on-treatment' period. The main-on-treatment period started at the date of first dose of trial product as recorded on the eCRF, and ended at the first date of any of the following: the end date of the on-treatment period; week 26. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.

Mean Total Weekly Insulin Dose: From Week 50 to Week 52

Mean total weekly insulin dose from week 50 to week 52 is presented. Data is reported for 'on-treatment' period. The on-treatment period: Onset date on or after the first dose of trial product and no later than the first date of either the follow-up visit (FU2), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin or the end-date for the in-trial period.

Change in Body Weight

Change in body weight from baseline to week 26 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation and ended at the date of: the last direct participant-site contact; withdrawal for participants who withdrew their informed consent; the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e. possibly an unscheduled phone visit); death for participants who died before any of the above.

Full Information

NCT ID

NCT04848480

First Posted

April 16, 2021

Last Updated

September 12, 2023

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT04848480

Brief Title

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)

Acronym

ONWARDS 6

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

April 30, 2021 (Actual)

Primary Completion Date

April 28, 2022 (Actual)

Study Completion Date

December 2, 2022 (Actual)

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

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

582 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin icodec + insulin aspart

Arm Type

Experimental

Arm Description

insulin icodec once a week in combination with 2-4 times daily injections of insulin aspart at meal times.

Arm Title

Insulin degludec + insulin aspart

Arm Type

Active Comparator

Arm Description

insulin degludec once a day in combination with 2-4 times daily injections of insulin aspart at meal times.

Intervention Type

Drug

Intervention Name(s)

insulin icodec

Intervention Description

insulin icodec 700 units/mL, subcutaneously (under the skin), solution for injection once weekly

Intervention Type

Drug

Intervention Name(s)

insulin degludec

Intervention Description

insulin degludec 100 units/mL, subcutaneously (under the skin), solution for injection once daily

Intervention Type

Drug

Intervention Name(s)

insulin aspart

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Glycosylated Haemoglobin (HbA1c) at Week 26

Description

Time Frame

Baseline (week 0), week 26

Secondary Outcome Measure Information:

Title

Change in Glycosylated Haemoglobin (HbA1c) at Week 52

Description

Time Frame

Baseline (week 0), week 52

Title

Change in Fasting Plasma Glucose (FPG)

Description

Time Frame

Baseline (week 0), week 26

Title

Percentage of Time in Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System

Description

Time Frame

From week 22 to week 26

Title

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction

Description

Time Frame

Baseline (week 0), week 26

Title

Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 26

Description

Time Frame

From baseline (week 0) to week 26

Title

Number of Severe Hypoglycaemic Episodes (Level 3): From Baseline (Week 0) to Week 57

Description

Time Frame

From baseline (week 0) to week 57

Title

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL) Confirmed by Blood Glucose [BG] Meter): From Baseline (Week 0) to Week 26

Description

Time Frame

From baseline (week 0) to week 26

Title

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL) Confirmed by BG Meter): From Baseline (Week 0) to Week 57

Description

Time Frame

From baseline (week 0) to week 57

Title

Description

Time Frame

From baseline (week 0) to week 26

Title

Description

Time Frame

From baseline (week 0) to week 57

Title

Description

Time Frame

From baseline (week 0) to week 26

Title

Description

Time Frame

From baseline (week 0) to week 57

Title

Percentage of Time spent Less Than (<) 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System

Description

Time Frame

From week 22 to week 26

Title

Percentage of Time spent Greater Than (>) 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System

Description

Time Frame

From week 22 to week 26

Title

Mean Total Weekly Insulin Dose: From Week 24 to Week 26

Description

Time Frame

From week 24 to week 26

Title

Mean Total Weekly Insulin Dose: From Week 50 to Week 52

Description

Time Frame

From week 50 to week 52

Title

Change in Body Weight

Description

Time Frame

Baseline (week 0), week 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Transparency (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Mateo

State/Province

California

ZIP/Postal Code

94401

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80246

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Fleming Island

State/Province

Florida

ZIP/Postal Code

32003

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33312

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Saint Augustine

State/Province

Florida

ZIP/Postal Code

32080

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

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

Nashua

State/Province

New Hampshire

ZIP/Postal Code

03060

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Albany

State/Province

New York

ZIP/Postal Code

12203

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

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605-4254

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37411

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

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78749

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

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77079

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78233

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Renton

State/Province

Washington

ZIP/Postal Code

98057

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Saint Stefan

ZIP/Postal Code

8511

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3C 0N2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

St. Johns

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 3V6

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4G 3E8

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Laval

State/Province

Quebec

ZIP/Postal Code

H7T 2P5

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

13597

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Essen

ZIP/Postal Code

45136

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Falkensee

ZIP/Postal Code

14612

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Lingen

ZIP/Postal Code

49808

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Ludwigshafen

ZIP/Postal Code

67059

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Lübeck

ZIP/Postal Code

23562

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Münster

ZIP/Postal Code

48145

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Oldenburg I. Holst

ZIP/Postal Code

23758

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Saint Ingbert-Oberwürzbach

ZIP/Postal Code

66386

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380 015

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Kozhikode

State/Province

Kerala

ZIP/Postal Code

673008

Country

India

Facility Name

Novo Nordisk Investigational Site

City

New Dehli

State/Province

New Delhi

ZIP/Postal Code

110029

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Hyderabad

ZIP/Postal Code

600034

Country

India

Facility Name

Novo Nordisk Investigational Site

City

New Delhi

ZIP/Postal Code

110001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Thriruvananthapuram

ZIP/Postal Code

695 032

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Catanzaro

ZIP/Postal Code

88100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Perugia

ZIP/Postal Code

06129

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Rome

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Koriyama-shi

State/Province

Fukushima, Japan

ZIP/Postal Code

963-8851

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Sapporo-shi, Hokkaido

State/Province

Hokkaido, Japan

ZIP/Postal Code

060-0062

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kumamoto-shi

State/Province

Kumamoto, Japan

ZIP/Postal Code

862-0976

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Chuo-ku, Tokyo

ZIP/Postal Code

103-0002

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kanagawa

ZIP/Postal Code

235-0045

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Sapporo-shi, Hokkaido

ZIP/Postal Code

060-0001

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

162 8666

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Apeldoorn

ZIP/Postal Code

7334 DZ

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Rotterdam

ZIP/Postal Code

3083 AN

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

117292

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

119034

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

123448

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint Petersburg

ZIP/Postal Code

191014

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saratov

ZIP/Postal Code

410031

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

St. Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Voronezh

ZIP/Postal Code

394018

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Oviedo

ZIP/Postal Code

33011

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sevilla

ZIP/Postal Code

41003

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Adana

ZIP/Postal Code

01130

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Aydin

ZIP/Postal Code

09010

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34371

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34400

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34668

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Malatya

ZIP/Postal Code

44280

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Derby

ZIP/Postal Code

DE1 2QY

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Guildford

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Oxford

ZIP/Postal Code

OX3 7LE

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Stevenage

ZIP/Postal Code

SG1 4AB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Swansea

ZIP/Postal Code

SA2 8PP

Country

United Kingdom

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

Citations:

PubMed Identifier

36106652

Citation

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.

Results Reference

result

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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)

Diabetes Mellitus, Type 1

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial