Back to results

Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status

Not yet recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Semaglutide

Empagliflozin

Metformin

About this trial

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

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female. Age ≥18 and <60 years at the time of signing the informed consent. Diagnosed with type 2 diabetes mellitus within 24 months from the day of screening. HbA1c of 7.0-10.0% (53-86 millimoles per mole [mmol/mol]) Body mass index ≥25.0 kilogram per square meter (kg/m^2) Exclusion Criteria: Treatment with any medication for the indication of diabetes. Prior insulin treatment for gestational diabetes is allowed. Treatment with any medication for the indication of weight management 90 days prior to screening. Renal impairment measured as estimated glomerular filtration rate (eGFR) <60 milliliters per minute per 1.73 meter sqaure (mL/min/1.73 m^2) at screening. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before 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. C-peptide <1.5 nanograms per milliliter (ng/mL) at screening. Positive insulinoma associated-protein 2 (IA-2) antibodies ≥7.5 Units/mL or anti-glutamic acid decarboxylase (anti-GAD) antibodies greater than (>) 5.0 international units per milliliter (IU/mL). Impaired liver function, defined as Alanine aminotransferase (ALT) ≥2.5 times or Bilirubin >1.5 times upper normal limit at screening. History of major surgical procedures involving the stomach potentially affecting absorption of trial products (example subtotal or total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant. Presence of clinically significant gastrointestinal disorders affecting absorption of drugs and/or nutrients, as judged by the investigator. Any contraindications for empagliflozin or metformin according to local labelling at the investigator's discretion

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Semaglutide 25 mg

Semaglutide 50 mg

Empagliflozin 25 mg

Metformin 2000 mg

Arm Description

Participants will receive 25 mg oral semaglutide once daily in maintenance period after dose escalation period.

Participants will receive 50 mg oral semaglutide once daily in maintenance period after dose escalation period.

Participants will 25 mg empagliflozin oral once daily in maintenance period after dose escalation period.

Participants will receive metformin 1000 mg orally twice daily (total 2000 mg) in maintenance period after dose escalation period.

Outcomes

Primary Outcome Measures

Change in glycated haemoglobin (HbA1c)

Measured in Percentage (%)-points.

Secondary Outcome Measures

Change in body weight

Measured in kilograms (kg).

Change in fasting plasma glucose (FPG)

Measured in millimoles per liter (mmol/L).

Change in 7 point self measured plasma glucose (SMPG) mean profile

Measured in mmol/L.

Change in 7-point self-measured plasma glucose (SMPG) mean post prandial increments

Measured in mmol/L.

Relative change in body weight

Measured in Percentage (%).

Change in waist circumference

Measured in centimeters (cm).

HbA1c less than or equal to (≤) 6.5% (Yes/No)

Measured as count of participants.

HbA1c less than (<) 7% (Yes/No)

Measured as count of participants.

Body weight reduction greater than equal to ( ≥) 5% (Yes/No)

Measured as count of participants.

Body weight reduction ≥10% (Yes/No)

Measured as count of participants.

Body weight reduction ≥15% (Yes/No)

Measured as count of participants.

HbA1c <7.0% and body weight reduction ≥5% (Yes/No)

Measured as count of participants.

Change in systolic blood pressure

Measured in millimeters of mercury (mmHg).

Change in diastolic blood pressure

Measured in mmHg.

Change in High-sensitivity C-reactive protein (hsCRP)

Measured in milligrams per liter (mg/L).

Time to rescue medication

Measured in days.

Change in HbA1c

Measured in %-points.

Change in body weight

Measured in kg.

Change in FPG

Measured in mmol/L.

Change in 7 point SMPG mean profile

Measured in mmol/L.

Change in 7-point SMPG mean post prandial increments

Measured in mmol/L

Relative change in body weight

Measured in Percentage.

Change in waist circumference

Measured in cm.

HbA1c ≤6.5% (Yes/No)

Measured as count of participants.

HbA1c <7.0% (Yes/No)

Measured as count of participants.

Body weight reduction ≥5% (Yes/No)

Measured as count of participants.

Body weight reduction ≥10% (Yes/No)

Measured as count of participants.

Body weight reduction ≥15% (Yes/No)

Measured as count of participants.

HbA1c <7.0% and body weight reduction ≥5% (Yes/No)

Measured as count of participants.

Change in systolic blood pressure

Measured in mmHg.

Change in diastolic blood pressure

Measured in mmHg.

Change in hsCRP

Measured in mg/L.

Treatment emergent adverse events

Measured as count of events.

Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes

Measured as count of episodes.

Treatment emergent adverse events

Measured as count of events.

Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes

Measured as count of episodes.

Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain

CoEQ is a 19-item multidimensional patient reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control.

Change in CoEQ score - Craving for Savory domain

CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving savoury food subscale, higher score represents a greater level of craving.

Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) score - Physical function domain

IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Composite scores (score range): Physical composite (0-100), Psychosocial composite (0 100), Physical Function composite (0-100). Total score range (0-100).

Change in American Heart Association (AHA) Life's Simple 7 summary score

The AHA recommends focusing on 7 cardiovascular health factors (smoking, BMI, physical activity, diet, total cholesterol, blood pressure, and fasting blood glucose) for early or primary prevention of cardiovascular disease. The 7 health factors are each categorized as ideal, intermediate, or poor. Scales range from 0 (minimum) to 14 (maximum). Higher score represents a greater level of health.

Change in CoEQ score - Craving Control domain

CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control.

Change in CoEQ score - Craving for Savory domain

Change in IWQOL-Lite-CT score - Physical function domain

Change in AHA Life's Simple 7 summary score

Full Information

NCT ID

NCT06083675

First Posted

October 9, 2023

Last Updated

October 9, 2023

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT06083675

Brief Title

Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes

Official Title

Efficacy and Safety of First Line Use of Oral Semaglutide 25 mg or 50 mg Once Daily Versus Empagliflozin 25 mg or Versus Metformin 2000 mg in Newly Diagnosed Treatment naïve Patients With Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 26, 2024 (Anticipated)

Primary Completion Date

January 24, 2025 (Anticipated)

Study Completion Date

May 28, 2027 (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

Data Monitoring Committee

5. Study Description

Brief Summary

This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes. This study will look mainly at how well participant's blood sugar and body weight are controlled when they are taking the study medicines. Participants will either get semaglutide tablets, empagliflozin tablets or metformin tablets. Which treatment participants will get is decided by chance. Currently, doses of 3 milligram (mg), 7 mg and 14 mg semaglutide tablets (Rybelsus) can be prescribed in some countries. 25 mg and 50 mg semaglutide tablets are new doses. 10 mg and 25 mg empagliflozin tablets (Jardiance) can be prescribed in some countries. 500 mg metformin tablets (STADA) can be prescribed in some countries. Participants will get 1 to 4 tablets per day for 104 weeks. The study will last for about 2 years and 7 weeks (111 weeks). Participants should not have been treated for weight management 90 days before screening or never been treated with any medicine for type 2 diabetes (except diabetes during pregnancy) before screening. Women cannot take part if pregnant, breast-feeding or plan 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

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

912 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide 25 mg

Arm Type

Experimental

Arm Description

Participants will receive 25 mg oral semaglutide once daily in maintenance period after dose escalation period.

Arm Title

Semaglutide 50 mg

Arm Type

Experimental

Arm Description

Participants will receive 50 mg oral semaglutide once daily in maintenance period after dose escalation period.

Arm Title

Empagliflozin 25 mg

Arm Type

Experimental

Arm Description

Participants will 25 mg empagliflozin oral once daily in maintenance period after dose escalation period.

Arm Title

Metformin 2000 mg

Arm Type

Experimental

Arm Description

Participants will receive metformin 1000 mg orally twice daily (total 2000 mg) in maintenance period after dose escalation period.

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Administered as oral tablets.

Intervention Type

Drug

Intervention Name(s)

Empagliflozin

Intervention Description

Administered as oral tablets.

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Administered as oral tablets.

Primary Outcome Measure Information:

Title

Change in glycated haemoglobin (HbA1c)

Description

Measured in Percentage (%)-points.

Time Frame

From randomisation (week 0) to week 52

Secondary Outcome Measure Information:

Title

Change in body weight

Description

Measured in kilograms (kg).

Time Frame

From randomisation (week 0) to week 52

Title

Change in fasting plasma glucose (FPG)

Description

Measured in millimoles per liter (mmol/L).

Time Frame

From randomisation (week 0) to week 52

Title

Change in 7 point self measured plasma glucose (SMPG) mean profile

Description

Measured in mmol/L.

Time Frame

From randomisation (week 0) to week 52

Title

Change in 7-point self-measured plasma glucose (SMPG) mean post prandial increments

Description

Measured in mmol/L.

Time Frame

From randomisation (week 0) to week 52

Title

Relative change in body weight

Description

Measured in Percentage (%).

Time Frame

From randomisation (week 0) to week 52

Title

Change in waist circumference

Description

Measured in centimeters (cm).

Time Frame

From randomisation (week 0) to week 52

Title

HbA1c less than or equal to (≤) 6.5% (Yes/No)

Description

Measured as count of participants.

Time Frame

At week 52

Title

HbA1c less than (<) 7% (Yes/No)

Description

Measured as count of participants.

Time Frame

At week 52

Title

Body weight reduction greater than equal to ( ≥) 5% (Yes/No)

Description

Measured as count of participants.

Time Frame

At week 52

Title

Body weight reduction ≥10% (Yes/No)

Description

Measured as count of participants.

Time Frame

At week 52

Title

Body weight reduction ≥15% (Yes/No)

Description

Measured as count of participants.

Time Frame

At week 52

Title

HbA1c <7.0% and body weight reduction ≥5% (Yes/No)

Description

Measured as count of participants.

Time Frame

At week 52

Title

Change in systolic blood pressure

Description

Measured in millimeters of mercury (mmHg).

Time Frame

From randomisation (week 0) to week 52

Title

Change in diastolic blood pressure

Description

Measured in mmHg.

Time Frame

From randomisation (week 0) to week 52

Title

Change in High-sensitivity C-reactive protein (hsCRP)

Description

Measured in milligrams per liter (mg/L).

Time Frame

From randomisation (week 0) to week 52

Title

Time to rescue medication

Description

Measured in days.

Time Frame

From randomisation (week 0) to week 104

Title

Change in HbA1c

Description

Measured in %-points.

Time Frame

From randomisation (week 0) to week 104

Title

Change in body weight

Description

Measured in kg.

Time Frame

From randomisation (week 0) to week 104

Title

Change in FPG

Description

Measured in mmol/L.

Time Frame

From randomisation (week 0) to week 104

Title

Change in 7 point SMPG mean profile

Description

Measured in mmol/L.

Time Frame

From randomisation (week 0) to week 104

Title

Change in 7-point SMPG mean post prandial increments

Description

Measured in mmol/L

Time Frame

From randomisation (week 0) to week 104

Title

Relative change in body weight

Description

Measured in Percentage.

Time Frame

From randomisation (week 0) to week 104

Title

Change in waist circumference

Description

Measured in cm.

Time Frame

From randomisation (week 0) to week 104

Title

HbA1c ≤6.5% (Yes/No)

Description

Measured as count of participants.

Time Frame

At week 104

Title

HbA1c <7.0% (Yes/No)

Description

Measured as count of participants.

Time Frame

At week 104

Title

Body weight reduction ≥5% (Yes/No)

Description

Measured as count of participants.

Time Frame

At week 104

Title

Body weight reduction ≥10% (Yes/No)

Description

Measured as count of participants.

Time Frame

At week 104

Title

Body weight reduction ≥15% (Yes/No)

Description

Measured as count of participants.

Time Frame

At week 104

Title

HbA1c <7.0% and body weight reduction ≥5% (Yes/No)

Description

Measured as count of participants.

Time Frame

At week 104

Title

Change in systolic blood pressure

Description

Measured in mmHg.

Time Frame

From randomisation (week 0) to week 104

Title

Change in diastolic blood pressure

Description

Measured in mmHg.

Time Frame

From randomisation (week 0) to week 104

Title

Change in hsCRP

Description

Measured in mg/L.

Time Frame

From randomisation (week 0) to week 104

Title

Treatment emergent adverse events

Description

Measured as count of events.

Time Frame

From randomisation (week 0) to week 52

Title

Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes

Description

Measured as count of episodes.

Time Frame

From randomisation (week 0) to week 52

Title

Treatment emergent adverse events

Description

Measured as count of events.

Time Frame

From randomisation (week 0) to follow-up visit (week 109)

Title

Number of severe (level 3) or clinically significant (level 2) hypoglycaemic episodes

Description

Measured as count of episodes.

Time Frame

From randomisation (week 0) to follow-up visit (week 109)

Title

Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain

Description

Time Frame

From randomisation (week 0) to week 52

Title

Change in CoEQ score - Craving for Savory domain

Description

Time Frame

From randomisation (week 0) to week 52

Title

Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) score - Physical function domain

Description

Time Frame

From randomisation (week 0) to week 52

Title

Change in American Heart Association (AHA) Life's Simple 7 summary score

Description

Time Frame

From randomisation (week 0) to week 52

Title

Change in CoEQ score - Craving Control domain

Description

CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control.

Time Frame

From randomisation (week 0) to week 104

Title

Change in CoEQ score - Craving for Savory domain

Description

Time Frame

From randomisation (week 0) to week 104

Title

Change in IWQOL-Lite-CT score - Physical function domain

Description

Time Frame

From randomisation (week 0) to week 104

Title

Change in AHA Life's Simple 7 summary score

Description

Time Frame

From randomisation (week 0) to week 104

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Novo Nordisk

Phone

(+1) 866-867-7178

clinicaltrials@novonordisk.com

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

Toluca Lake

State/Province

California

ZIP/Postal Code

91602

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Maumee

State/Province

Ohio

ZIP/Postal Code

43537

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Cedar Park

State/Province

Texas

ZIP/Postal Code

78613

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77061

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Waco

State/Province

Texas

ZIP/Postal Code

76708

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Goiânia

State/Province

Goias

ZIP/Postal Code

74935-330

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90430-001

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

01228-000

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

01228-200

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Kyustendil

ZIP/Postal Code

2500

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Plovdiv

ZIP/Postal Code

4018

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Samokov

ZIP/Postal Code

1000

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Velingrad

ZIP/Postal Code

4600

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Vratsa

ZIP/Postal Code

3000

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Osijek

State/Province

Osječko - Baranjska Županija

ZIP/Postal Code

31000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Karlovac

ZIP/Postal Code

47000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Krapinske Toplice

ZIP/Postal Code

49217

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

51000

Country

Croatia

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

GR-11527

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-15125

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-17562

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Haidari-Athens

ZIP/Postal Code

GR-12462

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Ioannina

ZIP/Postal Code

45500

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-54635

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

Szeged

State/Province

Csongrád-Csanád

ZIP/Postal Code

H-6725

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1089

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1132

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Debrecen

ZIP/Postal Code

4025

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Nyíregyháza

ZIP/Postal Code

4405

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Hyderabad

State/Province

A.p.

ZIP/Postal Code

500 063

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Guntur

State/Province

Andhra Pradesh

ZIP/Postal Code

522001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Vijaywada

State/Province

Andhra Pradesh

ZIP/Postal Code

520002

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Ahmedabad

State/Province

Gujrat

ZIP/Postal Code

380009

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Vadodara

State/Province

Gujrat

ZIP/Postal Code

390001

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560054

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

Mysuru

State/Province

Karnataka

ZIP/Postal Code

570001

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

Goa

State/Province

Maharashtra

ZIP/Postal Code

403 202

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Kolhapur

State/Province

Maharashtra

ZIP/Postal Code

416008

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

Thane

State/Province

Maharashtra

ZIP/Postal Code

421004

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Wardha

State/Province

Maharashtra

ZIP/Postal Code

442001

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

Ludhiana

State/Province

Punjab

ZIP/Postal Code

141001

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

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600 013

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

Hyderabad

State/Province

Telengana

ZIP/Postal Code

500082

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Lucknow

State/Province

Uttar Pradesh

ZIP/Postal Code

226030

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Kolkata,

State/Province

West Bengal

ZIP/Postal Code

700053

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Ahmedabad

ZIP/Postal Code

390013

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Aligarh

ZIP/Postal Code

202002

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Bhubaneshwar

ZIP/Postal Code

751007

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Maharashtra

ZIP/Postal Code

441108

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Puducherry

ZIP/Postal Code

605006

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Pune

ZIP/Postal Code

411057

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Warangal

ZIP/Postal Code

506002

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Sarawak

State/Province

Miri

ZIP/Postal Code

98000

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Bintulu

ZIP/Postal Code

97000

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Ipoh

ZIP/Postal Code

30450

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Melaka

ZIP/Postal Code

75400

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Temerloh,Pahang

ZIP/Postal Code

28000

Country

Malaysia

Facility Name

Novo Nordisk Investigational Site

City

Skierniewice

State/Province

Lodzkie

ZIP/Postal Code

96-100

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Siedlce

State/Province

Masovian

ZIP/Postal Code

08-110

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Bialystok

State/Province

Podlaskie Voivodeship

ZIP/Postal Code

15-879

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-605

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Chorzów

ZIP/Postal Code

41-500

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Grudziadz

ZIP/Postal Code

86-300

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Olsztyn

ZIP/Postal Code

10-117

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Opole

ZIP/Postal Code

45-301

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Poznań

ZIP/Postal Code

61-853

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Wroclaw

ZIP/Postal Code

52-416

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Łódź

ZIP/Postal Code

91-053

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Piotrków Trybunalski

State/Province

Łódzkie

ZIP/Postal Code

97-300

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Bucharest

State/Province

Bucurestii

ZIP/Postal Code

020475

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Targu Mures

State/Province

Mures

ZIP/Postal Code

540142

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Tirgu Mures

State/Province

Mures

ZIP/Postal Code

540142

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Braila

ZIP/Postal Code

810197

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Bucharest

ZIP/Postal Code

013764

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Bucuresti

ZIP/Postal Code

050913

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Ploiesti

ZIP/Postal Code

100561

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Satu-Mare

ZIP/Postal Code

440055

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

State/Province

ZIP/Postal Code

11050

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Kragujevac

State/Province

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Nis

State/Province

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Bangkok Noi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Klong Luang

State/Province

Pathum Thani

ZIP/Postal Code

12120

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Songkla

ZIP/Postal Code

90110

Country

Thailand

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

Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes

We'll reach out to this number within 24 hrs

Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes

Diabetes Mellitus, Type 2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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