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Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes (SUSTAIN 10)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Semaglutide

Liraglutide

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

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

Inclusion Criteria: - Male or female, age 18 years or older at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus - HbA1c of 7.0-11.0 % (53 - 97 mmol/mol) (both inclusive) - Stable daily dose(s) including any of the following anti-diabetic drug(s) or combination regimens 90 days prior to the day of screening: a) Biguanides (metformin above or equal to 1500 mg or maximum tolerated dose documented in the subject's medical record). b) Sulphonylureas (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record). c) SGLT-2 inhibitors (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) Exclusion Criteria: - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - History or presence of pancreatitis (acute or chronic) - History of diabetic ketoacidosis - 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 (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 ml/min/1.73 sqm as defined by KDIGO 2012 classification - Impaired liver function, defined as ALT above or equal to 2.5 times upper normal limit at screening - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Semaglutide

Liraglutide

Arm Description

Half the study participants are randomised to receive semaglutide

Half the study participants are randomised to receive liraglutide

Outcomes

Primary Outcome Measures

Change in HbA1c

Mean change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) %. The endpoint was evaluated based on the 'on-treatment without rescue medication period' where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Secondary Outcome Measures

Change in Body Weight (kg)

Mean change from baseline (week 0) to week 30 in body weight measured in kilograms. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Change in Fasting Plasma Glucose (FPG)

Mean change from baseline in fasting plasma glucose measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile

Mean change from baseline in 7-point profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. The mean of the 7-point SMPG profile, defined as the area under the profile, was calculated using the trapezoidal method and divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals)

Mean post prandial glucose incrememts over all meals. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Change in Fasting Blood Lipids: Total Cholesterol

The change from baseline in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol

The change from baseline in LDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol

The change from baseline in HDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Change in Fasting Blood Lipids: Triglycerides

The change from baseline in triglycerides is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Change in Body Mass Index (BMI)

Mean change from baseline (week 0) to week 30 in BMI. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Change in Waist Circumference

Mean change in waist circumference (cm) from baseline (week 0) to week 30. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Change in Systolic Blood Pressure

Change in systolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Change in Diastolic Blood Pressure

Change in diastolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Change in Body Weight (%)

Mean relative change from baseline in body weight measured in percentage. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target

Percentage of subjects who achieved HbA1c less than 7.0% (53 mmol/mol) according to American Diabetes Association (ADA) target, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target

Percentage of subjects who achieved HbA1c less than 6.5% (48 mmol/mol) according to AACE target,after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Subjects Who Achieve Weight Loss Above or Equal to 3%

Percentage of subjects who achieved weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Subjects Who Achieve Weight Loss Above or Equal to 5%

Percentage of subjects who achieved weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Subjects Who Achieve Weight Loss Above or Equal to 10%

Percentage of subjects who achieved weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain

Percentage of subjects who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Subjects Who Achieve HbA1c Reduction Above or Equal to 1%

Percentage of subjects who achieved weight loss above or equal to 1% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3%

Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5%

Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10%

Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains

Short form-36 version 2 (SF-36v2) is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL). The questionnaire measures the individual overall HRQoL on 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Each domain is scored using the sum of the individual item responses and normalised relative to the 2009 US reference population. Overall, the domain scores range from around 0-100 (higher scores indicated a better HRQoL), where the range of possible scores depends on the 2009 US reference population for each domain. The two total summary scores (mental and physical summary components) are calculated through weighted sums of the 8 domain scores. The presented result is the change from baseline (week 0) to week 30 in SF-36v2 scores. A positive change in score indicates an improvement since baseline.

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately

The DTSQs questionnaire was used to assess subject's treatment satisfaction. This instrument contains 8 items and measures the treatment for diabetes in terms of convenience, flexibility and general feelings regarding treatment. Q 1 = "satisfaction with current treatment"; Q 2 = "hyperglycemia"; Q 3 = "hypoglycemia"; Q 4 = "flexibility"; Q 5 = "convenience"; Q 6 = "understanding of diabetes"; Q 7 = "recommend treatment to others"; and Q 8 = "willingness to continue". Each item is rated on a 7-point Likert scale with a score ranging from 0 (ie, very dissatisfied) to 6 (ie, very satisfied). DTSQ items 2 and 3 are rated differently: 0 reflects 'never' and 6 reflects 'most of the time'. The 'treatment satisfaction' score is the sum of 6 of the 8 DTSQs components (Q 1, 4, 5, 6, 7 and 8) (range 0-36). Higher scores on the DTSQ total score indicate higher treatment satisfaction. The results presented is the change from baseline (week 0) to week 30 in DTSQ scores.

Number of Treatment-emergent Adverse Events (TEAE)

A TEAE was defined as an adverse event with onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period represents the time period where subjects were considered exposed to trial product.

Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes

Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes

Number of subjects with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes is presented. Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Change in Haematology - Haemoglobin

Mean change from baseline (week 0) to week 30 in haemoglobin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Change in Haematology - Haematocrit

Mean change from baseline (week 0) to week 30 in haematology laboratory parameter haematocrit. Haematocrit is the volume of red blood cells in the total blood. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Change in Haematology - Thrombocytes and Leukocytes

Mean change from baseline (week 0) to week 30 in haematology laboratory parameters thrombocytes and leukocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Change in Haematology - Erythrocytes

Mean change from baseline (week 0) to week 30 in haematology laboratory parameter erythrocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Change in Biochemistry - Calcium, Pottassium and Sodium

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters calcium, pottassium and sodium. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase.

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Change in Biochemistry - Amylase and Lipase

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters amylase and lypase. Observed data with multiple imputation for missing data is presented. Missing data were imputed using observed data from subjects within the same group defined by actual treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Change in Biochemistry - Creatinine and Bilirubin

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters creatinine and bilirubin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Change in Biochemistry - Albumin

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter albumin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR).

Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter eGFR. eGFR is calculated using the equation from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) as defined in KDIGO guidelines. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Change in Calcitonin

Mean change from baseline (week 0) to week 30 in calcitonin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Change in Pulse Rate

Mean change from baseline (week 0) to week 30 in pulse rate. Pulse rate is measured as number of heart beats per minute. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.

Full Information

NCT ID

NCT03191396

First Posted

June 16, 2017

Last Updated

October 2, 2019

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03191396

Brief Title

Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes

Acronym

SUSTAIN 10

Official Title

Efficacy and Safety of Semaglutide 1.0 mg Once-weekly Versus Liraglutide 1.2 mg Once-daily as add-on to 1-3 Oral Anti-diabetic Drugs (OADs) in Subjects With Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

June 27, 2017 (Actual)

Primary Completion Date

July 9, 2018 (Actual)

Study Completion Date

August 13, 2018 (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 is conducted in Europe. The aim of the study is to compare the effect of semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes. The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at the clinic and 3 phone calls with the study doctor. At the visits, participants will have a number of tests, for example: general health checks, blood samples, heart and eye checks etc. Participants will also fill in some forms about their health and satisfaction with their diabetes treatment.

6. Conditions and Keywords

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

Diabetes, 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

577 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide

Arm Type

Experimental

Arm Description

Half the study participants are randomised to receive semaglutide

Arm Title

Liraglutide

Arm Type

Active Comparator

Arm Description

Half the study participants are randomised to receive liraglutide

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Dose gradually increased to 1.0 mg, given s.c. (under the skin), once-weekly for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs (tablets), if any

Intervention Type

Drug

Intervention Name(s)

Liraglutide

Intervention Description

Dose gradually increased to 1.2 mg, given s.c. once-daily for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs, if any

Primary Outcome Measure Information:

Title

Change in HbA1c

Description

Time Frame

Week 0, week 30

Secondary Outcome Measure Information:

Title

Change in Body Weight (kg)

Description

Time Frame

Week 0, week 30

Title

Change in Fasting Plasma Glucose (FPG)

Description

Time Frame

Week 0, week 30

Title

Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile

Description

Time Frame

Week 0, week 30

Title

Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals)

Description

Time Frame

Week 0, week 30

Title

Change in Fasting Blood Lipids: Total Cholesterol

Description

Time Frame

Week 0, week 30

Title

Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol

Description

Time Frame

Week 0, week 30

Title

Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol

Description

Time Frame

Week 0, week 30

Title

Change in Fasting Blood Lipids: Triglycerides

Description

Time Frame

Week 0, week 30

Title

Change in Body Mass Index (BMI)

Description

Time Frame

Week 0, week 30

Title

Change in Waist Circumference

Description

Time Frame

Week 0, week 30

Title

Change in Systolic Blood Pressure

Description

Time Frame

Week 0, week 30

Title

Change in Diastolic Blood Pressure

Description

Time Frame

Week 0, week 30

Title

Change in Body Weight (%)

Description

Time Frame

Week 0, week 30

Title

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target

Description

Time Frame

After 30 weeks of treatment

Title

Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target

Description

Time Frame

After 30 weeks of treatment

Title

Subjects Who Achieve Weight Loss Above or Equal to 3%

Description

Time Frame

After 30 weeks of treatment

Title

Subjects Who Achieve Weight Loss Above or Equal to 5%

Description

Time Frame

After 30 weeks of treatment

Title

Subjects Who Achieve Weight Loss Above or Equal to 10%

Description

Time Frame

After 30 weeks of treatment

Title

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain

Description

Time Frame

After 30 weeks of treatment

Title

Subjects Who Achieve HbA1c Reduction Above or Equal to 1%

Description

Time Frame

After 30 weeks of treatment

Title

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3%

Description

Time Frame

After 30 weeks of treatment

Title

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5%

Description

Time Frame

After 30 weeks of treatment

Title

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10%

Description

Time Frame

After 30 weeks of treatment

Title

Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains

Description

Time Frame

Week 0, week 30

Title

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately

Description

Time Frame

Week 0, week 30

Title

Number of Treatment-emergent Adverse Events (TEAE)

Description

Time Frame

Week 0 to week 35

Title

Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes

Description

Time Frame

Week 0 to week 35

Title

Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes

Description

Time Frame

Week 0 to week 35

Title

Change in Haematology - Haemoglobin

Description

Mean change from baseline (week 0) to week 30 in haemoglobin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Time Frame

Week 0, week 30

Title

Change in Haematology - Haematocrit

Description

Time Frame

Week 0, week 30

Title

Change in Haematology - Thrombocytes and Leukocytes

Description

Time Frame

Week 0, week 30

Title

Change in Haematology - Erythrocytes

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry - Calcium, Pottassium and Sodium

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase.

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry - Amylase and Lipase

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry - Creatinine and Bilirubin

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry - Albumin

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR).

Description

Time Frame

Week 0, week 30

Title

Change in Calcitonin

Description

Mean change from baseline (week 0) to week 30 in calcitonin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.

Time Frame

Week 0, week 30

Title

Change in Pulse Rate

Description

Time Frame

Week 0, week 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Burgas

ZIP/Postal Code

8000

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Dupnitsa

ZIP/Postal Code

2600

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Lukovit

ZIP/Postal Code

5770

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Madan

ZIP/Postal Code

4900

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Petrich

ZIP/Postal Code

2850

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Ruse

ZIP/Postal Code

7000

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sliven

ZIP/Postal Code

8800

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Vratsa

ZIP/Postal Code

3001

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Brno

ZIP/Postal Code

65691

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Nachod

ZIP/Postal Code

547 01

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha 10

ZIP/Postal Code

100 00

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha 4

ZIP/Postal Code

140 46

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Helsinki

ZIP/Postal Code

00180

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Jyväskylä

ZIP/Postal Code

40100

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Kuusamo

ZIP/Postal Code

93600

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Lahti

ZIP/Postal Code

15110

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Oulu

ZIP/Postal Code

90220

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Rauma

ZIP/Postal Code

26100

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Turku

ZIP/Postal Code

20100

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Varkaus

ZIP/Postal Code

78300

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Béziers

ZIP/Postal Code

34500

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Dambach-la-ville

ZIP/Postal Code

67650

Country

France

Facility Name

Novo Nordisk Investigational Site

City

DIJON cedex

ZIP/Postal Code

21079

Country

France

Facility Name

Novo Nordisk Investigational Site

City

LA ROCHELLE cedex

ZIP/Postal Code

17019

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Le Coudray

ZIP/Postal Code

28630

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Le Creusot

ZIP/Postal Code

71200

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Nantes

ZIP/Postal Code

44200

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Obernai

ZIP/Postal Code

67210

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Paris

ZIP/Postal Code

75877

Country

France

Facility Name

Novo Nordisk Investigational Site

City

PERPIGNAN cedex

ZIP/Postal Code

66046

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Schiltigheim

ZIP/Postal Code

67300

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Venissieux

ZIP/Postal Code

69200

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Dresden

ZIP/Postal Code

01219

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

Hamburg

ZIP/Postal Code

22607

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

Stuttgart

ZIP/Postal Code

70378

Country

Germany

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

1125

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

Siófok

ZIP/Postal Code

8600

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Szolnok

ZIP/Postal Code

5004

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Tatabánya

ZIP/Postal Code

2800

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Bergamo

ZIP/Postal Code

24127

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Como

ZIP/Postal Code

22042

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Rome

ZIP/Postal Code

00168

Country

Italy

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

20-538

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Szczecin

ZIP/Postal Code

70-506

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Celje

ZIP/Postal Code

SI-3000

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

Ljubljana

ZIP/Postal Code

1525

Country

Slovenia

Facility Name

Novo Nordisk Investigational Site

City

Alcorcón

ZIP/Postal Code

28922

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Almería

ZIP/Postal Code

04001

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

La Roca del Vallés

ZIP/Postal Code

08430

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Palma de Mallorca

ZIP/Postal Code

07014

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Valladolid

ZIP/Postal Code

47010

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Vic (Barcelona)

ZIP/Postal Code

08500

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Kristianstad

ZIP/Postal Code

291 85

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Lund

ZIP/Postal Code

222 22

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Stockholm

ZIP/Postal Code

112 81

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Ängelholm

ZIP/Postal Code

262 81

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Örebro

ZIP/Postal Code

701 85

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Blackpool

ZIP/Postal Code

FY3 7EN

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Coventry

ZIP/Postal Code

CV2 2DX

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Crewe

ZIP/Postal Code

CW5 5NX

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Faringdon

ZIP/Postal Code

SN7 7YU.

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Hinckley

ZIP/Postal Code

LE10 2SE

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Northwood

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Norwich

ZIP/Postal Code

NR4 7TJ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Nuneaton

ZIP/Postal Code

CV10 7DJ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Rhyl

ZIP/Postal Code

LL18 1DA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Rotherham

ZIP/Postal Code

S65 1DA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Sidcup

ZIP/Postal Code

DA14 6LT

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Southampton

ZIP/Postal Code

SO30 3JB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

St Helens

ZIP/Postal Code

WA9 3DA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Truro

ZIP/Postal Code

TR1 3LJ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Watford

ZIP/Postal Code

WD25 7NL

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

Citations:

PubMed Identifier

31539622

Citation

Capehorn MS, Catarig AM, Furberg JK, Janez A, Price HC, Tadayon S, Verges B, Marre M. Efficacy and safety of once-weekly semaglutide 1.0mg vs once-daily liraglutide 1.2mg as add-on to 1-3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10). Diabetes Metab. 2020 Apr;46(2):100-109. doi: 10.1016/j.diabet.2019.101117. Epub 2019 Sep 17.

Results Reference

result

PubMed Identifier

32193837

Citation

Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jodar E. Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Diabetes Ther. 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Epub 2020 Mar 19.

Results Reference

derived

Learn more about this trial

Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes

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Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes (SUSTAIN 10)

Diabetes, 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

Learn more about this trial