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A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes (SUSTAIN 11)

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Semaglutide

Insulin aspart

Insulin glargine U100

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:

Male or female, age greater than or equal to 18 years at the time of signing informed consent
Diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening
Treated with basal insulin once daily or twice daily for greater than or equal to 90 days prior to the day of screening
Stable daily dose for 90 days prior to the day of screening of the following anti-diabetic drugs or combination regimens: Any metformin formulations (greater than or equal to 1500 mg to less than or equal to 3000 mg or maximum tolerated or effective dose documented in subject's medical record), alone or in combination (including fixed-dose drug combination) with up to one additional of the following oral antidiabetic drugs: sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors or alpha-glucosidase inhibitors
Glycated haemoglobin (HbA1c) of greater than 7.5% to less than or less than or equal to 10.0% (greater than 58 mmol/mol to less than or equal to 86 mmol/mol)

Exclusion Criteria:

History or presence of pancreatitis (acute or chronic)
Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
Subjects presently classified as being in New York Heart Association Class IV
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term bolus insulin treatment for a maximum of 14 days prior to the day of screening is allowed
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (for example, optometrist) within the past 90 days prior to run-in

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Semaglutide

Insulin aspart

Arm Description

Run-in period (12 weeks): subjects will be treated with metformin and insulin glargine (IGlar) U100. Treatment period: Participants who are not in glycaemic control (defined as HbA1c of more than or equal to 7.5% to less than or equal to 10%) after run-in will receive semaglutide for 52 weeks in addition to metformin and IGlar U100. Metformin will be considered as background therapy during the trial.

Run-in period (12 weeks): subjects will be treated with metformin and insulin IGlar U100. Treatment period: Participants who are not in glycaemic control (defined as HbA1c of more than or equal to 7.5% to less than or equal to 10%) after run-in receive insulin aspart for 52 weeks in addition to metformin and IGlar U100. Metformin will be considered as background therapy during the trial.

Outcomes

Primary Outcome Measures

Change From Baseline in Glycated Haemoglobin (HbA1c)

Change from baseline in HbA1c at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Secondary Outcome Measures

Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52

First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with plasma glucose (PG) less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligrams per deciliter (mg/dL)). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52

First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52

Number of EAC-confirmed severe hypoglycaemic episodes from randomization (week 0) up to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52

Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG <3.1 mmol/L (56 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode, that was BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52

Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG <=3.9 mmol/L (70 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode during which symptoms of hypoglycaemia were not accompanied by a PG determination but that was presumably caused by a PG concentration <= 3.9 mmol/L (70 mg/dL). Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52

Number of EAC-confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life-threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52

Number of EAC-confirmed severe or clinically significant hypoglycaemic episodes (plasma glucose < 3.0 mmol/L (54 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Hypoglycaemic episode with plasma glucose < 3.0 mmol/L (54 mg/dL)) was considered as clinically significant. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Daily Basal Insulin Dose at Week 52

Daily basal insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Total Daily Insulin Dose at Week 52

Total daily insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Change From Baseline to Week 52 in Body Weight (Kilogram (kg))

Change from baseline in body weight at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)

Change from baseline in FPG at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP)

Change from baseline in 7-point self-measured plasma glucose profile: mean 7-PP at week 52 is presented. All participants were instructed to perform 7-point SMPG profiles before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal (dinner), 90 minutes after the start of main evening meal (dinner) and at bedtime. The measurements were to be performed before any injection of bolus insulin and just before the start of the meal (breakfast, lunch or main evening meal), and values measured before breakfast were performed in a fasting condition. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals)

Change from baseline in 7-point SMPG profile: mean post-prandial increment (over all meals) at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Change From Baseline to Week 52 in Body Mass Index (BMI)

Change from baseline in BMI at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Change From Baseline to Week 52 in Waist Circumference

Change from baseline in waist circumference at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline

Change from baseline in body weight (measured in percentage) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline)

Change from baseline in total cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)

Change from baseline in LDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)

Change from baseline in HDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline)

Change from baseline in triglycerides (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure

Change from baseline in systolic and diastolic blood pressure at week 52 are presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Change From Baseline to Week 52 in Pulse Rate

Change from baseline in pulse rate at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains

SF-36v2 is 36-item patient-reported survey of patient health to measure participant's overall health-related quality of life (HRQoL). It has 36 items: 8 domains of physical, mental health status (physical functioning, role physical health (range:21.23-57.16), bodily pain (range: 21.68-62.00), general health (range: 18.95-66.50), vitality (range: 22.89-70.42), social functioning (range: 17.23-57.34), role emotional problem (range: 14.39-56.17) and mental health (range: 11.63-63.95)) and 2 total summary scores: physical components summary (range: 7.32-70.14) and mental components summary (range: 5.79-69.91) calculated from domain scores. All 10 scores range from 5.79-70.42 . Higher scores indicated a better health state. Change from baseline in SF-36v2, 2 summary and 8 domains scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from date of first dose of trial product (week 0) to last date on trial product with a visit window of +7 days (week 52).

Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains

The DQLCTQ-R questionnaire was used to assess participants' HRQoL. The DQLCTQ-R questionnaire contains 57 items and measures and provide scores for the 8 domains (physical function, energy or fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility and frequency of symptoms). The 8 domain scores related to DQLCTQ-R are measured on a scale from 0-100. For all scores, higher values indicated better health status. Change from baseline in DQLCTQ-R 8 domain scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).

Full Information

NCT ID

NCT03689374

First Posted

September 27, 2018

Last Updated

November 10, 2022

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03689374

Brief Title

A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

Acronym

SUSTAIN 11

Official Title

Effect of Semaglutide Once-weekly Versus Insulin Aspart Three Times Daily, Both as Add on to Metformin and Optimised Insulin Glargine (U100) in Subjects With Type 2 Diabetes A 52-week, Multi-centre, Multinational, Open-label, Active-controlled, Two Armed, Parallel-group, Randomised Trial in Subjects With Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

February 22, 2021 (Actual)

Study Completion Date

February 22, 2021 (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

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes. Participants will either get insulin glargine and semaglutide or insulin glargine and insulin aspart - which treatment the participant get is decided by chance. Insulin glargine is taken once a day and semaglutide once a week. Insulin aspart is taken three times per day before a meal. All three medicines come in pre-filled pens for injection under the skin. The study will last for about 71 weeks. If participant's blood sugar gets under or over certain values participant will only participate in 14 weeks. The study doctor will inform the participant about this. The participant will have 15 clinic visits and 22 phone calls with the study doctor.

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

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2274 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide

Arm Type

Experimental

Arm Description

Arm Title

Insulin aspart

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Subjects will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) with a dose of 0.25 mg. The dose should be increased after four weeks to 0.5 mg semaglutide. After 4 more weeks the dose can be increased to 1.0 mg semaglutide if the study doctor decides and further dose adjusted throughout the study.

Intervention Type

Drug

Intervention Name(s)

Insulin aspart

Intervention Description

Subjects should initiate treatment with 4U of Insulin aspart (s.c. injections) before each main meal, three times daily (TID). The dose will be adjusted individually based on pre-prandial and bedtime self measured plasma glucose (SMPG) from the preceding 3 days

Intervention Type

Drug

Intervention Name(s)

Insulin glargine U100

Intervention Description

Run-in period: Subjects will receive s.c. injections of IGlar U100 OD in accordance with the approved local label of IGlar U100. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.0-6.9 mmol/L)

Primary Outcome Measure Information:

Title

Change From Baseline in Glycated Haemoglobin (HbA1c)

Description

Time Frame

Baseline (week 0), week 52

Secondary Outcome Measure Information:

Title

Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52

Description

Time Frame

From randomization (week 0) up to week 52

Title

Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52

Description

Time Frame

From randomization (week 0) up to week 52

Title

Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52

Description

Time Frame

From randomization (week 0) to week 52

Title

Description

Time Frame

From randomization (week 0) to week 52

Title

Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52

Description

Time Frame

From randomization (week 0) to week 52

Title

Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52

Description

Time Frame

From randomization (week 0) to week 52

Title

Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52

Description

Time Frame

From randomization (week 0) to week 52

Title

Daily Basal Insulin Dose at Week 52

Description

Time Frame

At week 52

Title

Total Daily Insulin Dose at Week 52

Description

Time Frame

At week 52

Title

Change From Baseline to Week 52 in Body Weight (Kilogram (kg))

Description

Time Frame

Baseline (week 0), week 52

Title

Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)

Description

Time Frame

Baseline (week 0), week 52

Title

Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP)

Description

Time Frame

Baseline (week 0), week 52

Title

Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals)

Description

Time Frame

Baseline (week 0), week 52

Title

Change From Baseline to Week 52 in Body Mass Index (BMI)

Description

Time Frame

Baseline (week 0), week 52

Title

Change From Baseline to Week 52 in Waist Circumference

Description

Time Frame

Baseline (week 0), week 52

Title

Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline

Description

Time Frame

Baseline (week 0), week 52

Title

Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline)

Description

Time Frame

Baseline (week 0), week 52

Title

Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)

Description

Time Frame

Baseline (week 0), week 52

Title

Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)

Description

Time Frame

Baseline (week 0), week 52

Title

Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline)

Description

Time Frame

Baseline (week 0), week 52

Title

Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure

Description

Time Frame

Baseline (week 0), week 52

Title

Change From Baseline to Week 52 in Pulse Rate

Description

Time Frame

Baseline (week 0), week 52

Title

Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains

Description

Time Frame

Baseline (week 0), week 52

Title

Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains

Description

Time Frame

Baseline (week 0), week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, age greater than or equal to 18 years at the time of signing informed consent Diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening Treated with basal insulin once daily or twice daily for greater than or equal to 90 days prior to the day of screening Stable daily dose for 90 days prior to the day of screening of the following anti-diabetic drugs or combination regimens: Any metformin formulations (greater than or equal to 1500 mg to less than or equal to 3000 mg or maximum tolerated or effective dose documented in subject's medical record), alone or in combination (including fixed-dose drug combination) with up to one additional of the following oral antidiabetic drugs: sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors or alpha-glucosidase inhibitors Glycated haemoglobin (HbA1c) of greater than 7.5% to less than or less than or equal to 10.0% (greater than 58 mmol/mol to less than or equal to 86 mmol/mol) Exclusion Criteria: History or presence of pancreatitis (acute or chronic) Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening Subjects presently classified as being in New York Heart Association Class IV Planned coronary, carotid or peripheral artery revascularisation known on the day of screening Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term bolus insulin treatment for a maximum of 14 days prior to the day of screening is allowed Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (for example, optometrist) within the past 90 days prior to run-in

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Reporting Anchor and Disclosure (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Banja Luka

ZIP/Postal Code

78000

Country

Bosnia and Herzegovina

Facility Name

Novo Nordisk Investigational Site

City

Sarajevo

ZIP/Postal Code

71000

Country

Bosnia and Herzegovina

Facility Name

Novo Nordisk Investigational Site

City

Tuzla

ZIP/Postal Code

75000

Country

Bosnia and Herzegovina

Facility Name

Novo Nordisk Investigational Site

City

Burgas

ZIP/Postal Code

8000

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Byala

ZIP/Postal Code

7100

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Dimitrovgrad

ZIP/Postal Code

6400

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Ruse

ZIP/Postal Code

7000

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1632

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Stara Zagora

ZIP/Postal Code

6001

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Karlovac

ZIP/Postal Code

47000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Osijek

ZIP/Postal Code

31 000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Pula

ZIP/Postal Code

52100

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Rijeka

ZIP/Postal Code

51 000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Varazdin

ZIP/Postal Code

42 000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Zagreb

ZIP/Postal Code

10 000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Beroun

ZIP/Postal Code

26601

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Kladno - Krocehlavy

ZIP/Postal Code

272 01

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Mlada Boleslav

ZIP/Postal Code

293 50

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Nachod

ZIP/Postal Code

54701

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Olomouc

ZIP/Postal Code

77900

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Plzeň

ZIP/Postal Code

301 00

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Prostejov

ZIP/Postal Code

79601

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Pärnu

ZIP/Postal Code

80018

Country

Estonia

Facility Name

Novo Nordisk Investigational Site

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

Novo Nordisk Investigational Site

City

Tallinn

ZIP/Postal Code

10617

Country

Estonia

Facility Name

Novo Nordisk Investigational Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Novo Nordisk Investigational Site

City

Viljandi

ZIP/Postal Code

71024

Country

Estonia

Facility Name

Novo Nordisk Investigational Site

City

Bad Kreuznach

ZIP/Postal Code

55545

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Bad Mergentheim

ZIP/Postal Code

97980

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

10437

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

10629

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

13597

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Eisenach

ZIP/Postal Code

99817

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Essen

ZIP/Postal Code

45136

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Essen

ZIP/Postal Code

45355

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Essen

ZIP/Postal Code

45359

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Esslingen

ZIP/Postal Code

73728

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Falkensee

ZIP/Postal Code

14612

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Friedrichsthal

ZIP/Postal Code

66299

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Hamburg

ZIP/Postal Code

22041

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Hamburg

ZIP/Postal Code

22607

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Hohenmölsen

ZIP/Postal Code

06679

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Jerichow

ZIP/Postal Code

39319

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Kiel Kronshagen

ZIP/Postal Code

24119

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Leipzig

ZIP/Postal Code

04249

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Münster

ZIP/Postal Code

48145

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Münster

ZIP/Postal Code

48153

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

Pohlheim

ZIP/Postal Code

35415

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Rehlingen-Siersburg

ZIP/Postal Code

66780

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

Schwabenheim

ZIP/Postal Code

55270

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Schweinfurt

ZIP/Postal Code

97421

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Stuhr

ZIP/Postal Code

28816

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Stuttgart

ZIP/Postal Code

70199

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Stuttgart

ZIP/Postal Code

70378

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Villingen-Schwenningen

ZIP/Postal Code

78048

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Alexandroupolis

ZIP/Postal Code

GR-68100

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

115 21

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

115 25

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

11522

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-115 27

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-11521

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-11526

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-11527

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Larissa

ZIP/Postal Code

GR-41110

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Piraeus

ZIP/Postal Code

GR-18536

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-54642

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-54643

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-57001

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-57010

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1033

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1042

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1089

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Nagykanizsa

ZIP/Postal Code

8800

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Pécs

ZIP/Postal Code

7623

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Salgótarján

ZIP/Postal Code

3100

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Szeged

ZIP/Postal Code

H-6725

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500072

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Ahmedabad

State/Province

Gujarat

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560034

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560092

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Indore

State/Province

Madhya Pradesh

ZIP/Postal Code

452010

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400012

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400058

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440010

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411040

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Delhi

State/Province

New Delhi

ZIP/Postal Code

110002

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

Bhubaneswar

State/Province

Orissa

ZIP/Postal Code

751005

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Bhubaneswar

State/Province

Orissa

ZIP/Postal Code

751019

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Chandigarh

State/Province

Punjab

ZIP/Postal Code

160012

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Ludhiana

State/Province

Punjab

ZIP/Postal Code

141001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Mohali

State/Province

Punjab

ZIP/Postal Code

160062

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302006

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Madurai

State/Province

Tamil Nadu

ZIP/Postal Code

625 020

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Hyderabad

State/Province

Telengana

ZIP/Postal Code

500003

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Hyderbad

State/Province

Telengana

ZIP/Postal Code

500 012

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Kolkata

State/Province

West Bengal

ZIP/Postal Code

700054

Country

India

Facility Name

Novo Nordisk Investigational Site

City

New Delhi

ZIP/Postal Code

110001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Jelgava

ZIP/Postal Code

LV-3001

Country

Latvia

Facility Name

Novo Nordisk Investigational Site

City

Ogre

ZIP/Postal Code

LV-5001

Country

Latvia

Facility Name

Novo Nordisk Investigational Site

City

Riga

ZIP/Postal Code

LV-1002

Country

Latvia

Facility Name

Novo Nordisk Investigational Site

City

Riga

ZIP/Postal Code

LV-1024

Country

Latvia

Facility Name

Novo Nordisk Investigational Site

City

Sigulda

ZIP/Postal Code

LV-2150

Country

Latvia

Facility Name

Novo Nordisk Investigational Site

City

Talsi

ZIP/Postal Code

LV-3201

Country

Latvia

Facility Name

Novo Nordisk Investigational Site

City

Kaunas

ZIP/Postal Code

48259

Country

Lithuania

Facility Name

Novo Nordisk Investigational Site

City

Kaunas

ZIP/Postal Code

49449

Country

Lithuania

Facility Name

Novo Nordisk Investigational Site

City

Kaunas

ZIP/Postal Code

50009

Country

Lithuania

Facility Name

Novo Nordisk Investigational Site

City

Panevezys

ZIP/Postal Code

37355

Country

Lithuania

Facility Name

Novo Nordisk Investigational Site

City

Vilnius

ZIP/Postal Code

04318

Country

Lithuania

Facility Name

Novo Nordisk Investigational Site

City

Vilnius

ZIP/Postal Code

08661

Country

Lithuania

Facility Name

Novo Nordisk Investigational Site

City

Skopje

ZIP/Postal Code

1000

Country

North Macedonia

Facility Name

Novo Nordisk Investigational Site

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Bialystok

ZIP/Postal Code

15-704

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Gorzow Wielkopolski

ZIP/Postal Code

66-400

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Lodz

ZIP/Postal Code

94-074 LODZ

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Lublin

ZIP/Postal Code

20-044

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Lublin

ZIP/Postal Code

20-090

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Lublin

ZIP/Postal Code

20-538

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Poznan

ZIP/Postal Code

60-589

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Poznan

ZIP/Postal Code

61-251

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Poznan

ZIP/Postal Code

61-853

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Pulawy

ZIP/Postal Code

24-100

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Ruda Slaska

ZIP/Postal Code

41-709

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Siedlce

ZIP/Postal Code

08-110

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Skorzewo

ZIP/Postal Code

60-185

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Warsaw

ZIP/Postal Code

00-465

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Wierzchoslawice

ZIP/Postal Code

33-122

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Wroclaw

ZIP/Postal Code

50-127

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Wroclaw

ZIP/Postal Code

51-685

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Almada

ZIP/Postal Code

2805-267

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Braga

ZIP/Postal Code

4710-243

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Coimbra

ZIP/Postal Code

3000-561

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Lisboa

ZIP/Postal Code

1250-230

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Loures

ZIP/Postal Code

2674-514

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Setubal

ZIP/Postal Code

2910-446

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Cluj Napoca

State/Province

Cluj

ZIP/Postal Code

400006

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Targoviste

State/Province

Dambovita

ZIP/Postal Code

130086

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Targu Mures

State/Province

Mures

ZIP/Postal Code

540098

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Ploiesti

State/Province

Prahova

ZIP/Postal Code

100018

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Brasov

ZIP/Postal Code

500101

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Brasov

ZIP/Postal Code

500283

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Galati

ZIP/Postal Code

800578

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11080

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Zajecar

ZIP/Postal Code

19000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Bardejov

ZIP/Postal Code

08501

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Bratislava

ZIP/Postal Code

811 08

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Bratislava

ZIP/Postal Code

81108

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Bratislava

ZIP/Postal Code

82606

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Dolny Kubin

ZIP/Postal Code

02601

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Levice

ZIP/Postal Code

93401

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Lubochna

ZIP/Postal Code

03491

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Martin

ZIP/Postal Code

03601

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Prievidza

ZIP/Postal Code

97101

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Sabinov

ZIP/Postal Code

08301

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Brezice

ZIP/Postal Code

8250

Country

Slovenia

Facility Name

Novo Nordisk Investigational Site

City

Jesenice

ZIP/Postal Code

SI-4270

Country

Slovenia

Facility Name

Novo Nordisk Investigational Site

City

Koper

ZIP/Postal Code

SI-6000

Country

Slovenia

Facility Name

Novo Nordisk Investigational Site

City

Murska Sobota

ZIP/Postal Code

SI-9000

Country

Slovenia

Facility Name

Novo Nordisk Investigational Site

City

Nova Gorica

ZIP/Postal Code

SI-5000

Country

Slovenia

Facility Name

Novo Nordisk Investigational Site

City

Nova Gorica

ZIP/Postal Code

SI-5290

Country

Slovenia

Facility Name

Novo Nordisk Investigational Site

City

Benoni

State/Province

Gauteng

ZIP/Postal Code

1501

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Cosmo City

State/Province

Gauteng

ZIP/Postal Code

2188

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

1818

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2198

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Lenasia

State/Province

Gauteng

ZIP/Postal Code

1827

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0122

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Durban

State/Province

KwaZulu-Natal

ZIP/Postal Code

4092

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Durban

State/Province

KwaZulu-Natal

ZIP/Postal Code

4450

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Umkomaas

State/Province

KwaZulu-Natal

ZIP/Postal Code

4170

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Almeria

ZIP/Postal Code

04009

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Antequera

ZIP/Postal Code

29200

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Fuenlabrada - Madrid

ZIP/Postal Code

28942

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Málaga

ZIP/Postal Code

29006

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Palma de Mallorca

ZIP/Postal Code

07010

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Segovia

ZIP/Postal Code

40002

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

Ankara

ZIP/Postal Code

06500

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Antalya

ZIP/Postal Code

07058

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Denizli

ZIP/Postal Code

20070

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Erzurum

ZIP/Postal Code

25240

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34303

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34390

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

34722

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34760

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34899

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Trabzon

ZIP/Postal Code

61080

Country

Turkey

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

35546450

Citation

Kellerer M, Kaltoft MS, Lawson J, Nielsen LL, Strojek K, Tabak O, Jacob S. Effect of once-weekly semaglutide versus thrice-daily insulin aspart, both as add-on to metformin and optimized insulin glargine treatment in participants with type 2 diabetes (SUSTAIN 11): A randomized, open-label, multinational, phase 3b trial. Diabetes Obes Metab. 2022 Sep;24(9):1788-1799. doi: 10.1111/dom.14765. Epub 2022 Jun 29.

Results Reference

result

Learn more about this trial

A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

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A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes (SUSTAIN 11)

Diabetes Mellitus, Type 2

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

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