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Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus (SUSTAIN 9)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Semaglutide

Placebo

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:

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male or female, above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age equal to or above 20 years at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus
HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive)
Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (equal to or above 1500 mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of screening. All medications in compliance with current local label

Exclusion Criteria:

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
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 insulin treatment for a maximum of 14 days prior to the day of screening is allowed
Subjects with alanine aminotransferase above 2.5 x upper normal limit
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 Class IV
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
Renal impairment measured as estimated Glomerular Filtration Rate value of eGFR below 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry for serum creatinine measured 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
Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c

Change from baseline (week 0) in HbA1c was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: 1) the last dose of trial product + 7 days or 2) initiation of rescue medication.

Secondary Outcome Measures

Change in Body Weight (kg)

Change from baseline (week 0) in body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Change in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

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

Change from baseline (week 0) in mean of the SMPG, 7-point profile was evaluated at week 30. Mean 7-point profile (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. Participants measured their plasma glucose at 7 different time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime.

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

Change from baseline (week 0) in mean post prandial increment (over all meals) in the SMPG, 7-point profile was evaluated at week 30. The mean increment over all meals was derived as the mean of all available meal increments. Results are based on the 'on-treatment without rescue medication' observation period.

Change in Fasting Blood Lipid, Total Cholesterol

Change from baseline (week 0) in total cholesterol (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol

Change from baseline (week 0) in LDL (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Change in Fasting Blood Lipid, High-density Lipoprotein (HDL) Cholesterol

Change from baseline (week 0) in HDL (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Change in Fasting Blood Lipid, Triglycerides

Change from baseline (week 0) in triglycerides (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Change in Body Weight (%)

Percent (%) change from baseline (week 0) in body weight (measured in kilogram (kg)) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Change in Body Mass Index

Change from baseline (week 0) in body mass index (BMI) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'.

Change in Waist Circumference

Change from baseline (week 0) in waist circumference was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Change in Systolic Blood Pressure

Change from baseline (week 0) in systolic blood pressure was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Change in Diastolic Blood Pressure

Change from baseline (week 0) in diastolic blood pressure was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains

Change from baseline (week 0) in patient reported outcome (PRO) questionnaire, SF-36v2TM was evaluated at week 30. The SF-36v2™ questionnaire was used to assess the overall health related quality of life of participants. This questionnaire contains 36 items and measures the individual overall health related quality of life on 8 domains: 1) Physical functioning, 2) Role functioning, 3) Bodily pain, 4) General health, 5) Vitality, 6) Social functioning, 7) Role emotional and 8) Mental health. Each item is scored on a scale from 1 to either 2, 3, 5, or 6; each item score is then converted to a scale of 0-100, representing the percentage of total possible score achieved and with higher scores indicating a higher health status; items on the same scale are then averaged to obtain the 8 scale scores. Physical component summary (PCS) includes domains 1-4 and mental component summary (MCS) includes domains 5-8. Higher PCS and MCS scores on a scale of 0-100 indicate a higher health status.

Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately

Change from baseline (week 0) in PRO questionnaire, DTSQ was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. The DTSQ measures satisfaction with diabetes treatment. The DTSQ consists of 8 items evaluating 6 aspects of treatment satisfaction and 2 perceived recent event rates of hyperglycemia/hypoglycemia. Each item is scored on a 7- point Likert scale ranging from 0 (very dissatisfied) to 6 (very satisfied). Items evaluating 6 aspects (items 3-8) of treatment satisfaction are summed to produce a total treatment satisfaction score; DTSQ status total scores range from 0-36, with higher scores indicating greater satisfaction; the perceived frequency of hyperglycemia/hypoglycemia items are scored separately, with lower scores indicating better perceived blood glucose control.

HbA1c Below 7.0% (53 mmol/Mol)

Percentage of participants with HbA1c below 7.0% (53 mmol/mol) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

HbA1c Equal to or Below 6.5% (48 mmol/Mol)

Percentage of participants with HbA1c equal to or below 6.5% (48 mmol/mol) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Weight Loss Equal to or Above 3%

Percentage of participants with weight loss equal to or above 3% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Weight Loss Equal to or Above 5%

Percentage of participants with weight loss equal to or above 5% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Weight Loss Equal to or Above 10%

Percentage of participants with weight loss equal to or above 10% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

HbA1c Below 7.0% (53 mmol/Mol) Without Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain

Percentage of participants with HbA1c below 7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain from their baseline (week 0) body weight was evaluated at week 30. Severe or blood glucose (BG)-confirmed symptomatic hypoglycaemia: an episode that was severe according to the American Diabetes Association (ADA) classification or confirmed by a plasma glucose (PG) value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment without rescue medication' observation period.

HbA1c Reduction Equal to or Above 1%-Point

Percentage of participants with HbA1c reduction equal to or above 1%-point was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 3%

Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 3% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 5%

Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 5% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 10%

Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 10% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Number of Treatment-emergent Adverse Events (TEAEs)

A TEAE was defined as an event that has onset date (or increase in severity) during the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days.

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or confirmed by a PG value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Change in Haematology: Haemoglobin

Change from baseline (week 0) in haemoglobin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Haematology: Haematocrit

Change from baseline (week 0) in haematocrit was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Haematology: Thrombocytes

Change from baseline (week 0) in thrombocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Haematology: Erythrocytes

Change from baseline (week 0) in erythrocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Haematology: Leucocytes

Change from baseline (week 0) in leucocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Biochemistry: Amylase

Change from baseline (week 0) in amylase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Biochemistry: Lipase

Change from baseline (week 0) in lipase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Biochemistry: Alkaline Phosphatase

Change from baseline (week 0) in alkaline phosphatase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Biochemistry: Alanine Aminotransferase

Change from baseline (week 0) in alanine aminotransferase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Biochemistry: Aspartate Aminotransferase

Change from baseline (week 0) in aspartate aminotransferase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Biochemistry: Total Bilirubin

Change from baseline (week 0) in total bilirubin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Biochemistry: Albumin

Change from baseline (week 0) in albumin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Biochemistry: Calcium (Total)

Change in Biochemistry: Potassium

Change from baseline (week 0) in potassium was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Biochemistry: Sodium

Change from baseline (week 0) in sodium was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Biochemistry: Bicarbonate

Change from baseline (week 0) in bicarbonate was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Biochemistry: Estimated Glomerular Filtration Rate (eGFR)

Change from baseline (week 0) in eGFR was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Biochemistry: Creatinine

Change from baseline (week 0) in creatinine was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Calcitonin

Change from baseline (week 0) in calcitonin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Pulse

Change from baseline (week 0) in pulse rate was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Electrocardiogram

Electrocardiogram (ECG) results are presented for week 0 (baseline) and week 30. ECG finding are presented as percentage of participants with normal, abnormal non-clinically significant (NCS) and abnormal clinically significant (CS) ECG values. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days.

Change in Physical Examination: General Appearance

Physical examination (general appearance) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Physical Examination: Central and Peripheral Nervous System

Physical examination (central and peripheral nervous system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Physical Examination: Cardiovascular System

Physical examination (cardiovascular system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Physical Examination: Gastrointestinal System Including Mouth

Physical examination (gastrointestinal system including mouth) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Physical Examination: Skin

Physical examination (skin) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Physical Examination: Respiratory System

Physical examination (respiratory system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Physical Examination: Lymph Node Palpation

Physical examination (lymph node palpation) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Physical Examination: Thyroid Gland

Physical examination (thyroid gland) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Change in Fundoscopy

Fundoscopy results for both left and right eyes are presented for week 0 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.

Full Information

NCT ID

NCT03086330

First Posted

March 14, 2017

Last Updated

July 1, 2021

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03086330

Brief Title

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus

Acronym

SUSTAIN 9

Official Title

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus. A 30-week Randomised, Double-blind, Placebo-controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

March 15, 2017 (Actual)

Primary Completion Date

July 4, 2018 (Actual)

Study Completion Date

August 6, 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

Data Monitoring Committee

5. Study Description

Brief Summary

This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.

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

ParticipantInvestigator

Allocation

Randomized

Enrollment

302 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Semaglutide, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Semaglutide placebo, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks

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

Change from baseline (week 0) in body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Time Frame

Week 0, week 30

Title

Change in Fasting Plasma Glucose (FPG)

Description

Change from baseline (week 0) in FPG was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

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 Lipid, Total Cholesterol

Description

Time Frame

Week 0, week 30

Title

Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol

Description

Time Frame

Week 0, week 30

Title

Change in Fasting Blood Lipid, High-density Lipoprotein (HDL) Cholesterol

Description

Time Frame

Week 0, week 30

Title

Change in Fasting Blood Lipid, Triglycerides

Description

Time Frame

Week 0, week 30

Title

Change in Body Weight (%)

Description

Percent (%) change from baseline (week 0) in body weight (measured in kilogram (kg)) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Time Frame

Week 0, week 30

Title

Change in Body Mass Index

Description

Time Frame

Week 0, week 30

Title

Change in Waist Circumference

Description

Change from baseline (week 0) in waist circumference was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Time Frame

Week 0, week 30

Title

Change in Systolic Blood Pressure

Description

Change from baseline (week 0) in systolic blood pressure was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Time Frame

Week 0, week 30

Title

Change in Diastolic Blood Pressure

Description

Change from baseline (week 0) in diastolic blood pressure was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Time Frame

Week 0, week 30

Title

Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains

Description

Time Frame

Week 0, week 30

Title

Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately

Description

Time Frame

Week 0, week 30

Title

HbA1c Below 7.0% (53 mmol/Mol)

Description

Percentage of participants with HbA1c below 7.0% (53 mmol/mol) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Time Frame

After 30 weeks

Title

HbA1c Equal to or Below 6.5% (48 mmol/Mol)

Description

Percentage of participants with HbA1c equal to or below 6.5% (48 mmol/mol) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Time Frame

After 30 weeks

Title

Weight Loss Equal to or Above 3%

Description

Time Frame

After 30 weeks

Title

Weight Loss Equal to or Above 5%

Description

Time Frame

After 30 weeks

Title

Weight Loss Equal to or Above 10%

Description

Time Frame

After 30 weeks

Title

HbA1c Below 7.0% (53 mmol/Mol) Without Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain

Description

Time Frame

After 30 weeks

Title

HbA1c Reduction Equal to or Above 1%-Point

Description

Percentage of participants with HbA1c reduction equal to or above 1%-point was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.

Time Frame

After 30 weeks

Title

HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 3%

Description

Time Frame

After 30 weeks

Title

HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 5%

Description

Time Frame

After 30 weeks

Title

HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 10%

Description

Time Frame

After 30 weeks

Title

Number of Treatment-emergent Adverse Events (TEAEs)

Description

Time Frame

Week 0 - week 30

Title

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Description

Time Frame

Week 0 - week 30

Title

Change in Haematology: Haemoglobin

Description

Time Frame

Week 0, week 30

Title

Change in Haematology: Haematocrit

Description

Time Frame

Week 0, week 30

Title

Change in Haematology: Thrombocytes

Description

Time Frame

Week 0, week 30

Title

Change in Haematology: Erythrocytes

Description

Time Frame

Week 0, week 30

Title

Change in Haematology: Leucocytes

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry: Amylase

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry: Lipase

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry: Alkaline Phosphatase

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry: Alanine Aminotransferase

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry: Aspartate Aminotransferase

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry: Total Bilirubin

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry: Albumin

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry: Calcium (Total)

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry: Potassium

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry: Sodium

Description

Time Frame

Week 0, week 30

Title

Change in Biochemistry: Bicarbonate

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 Biochemistry: Creatinine

Description

Time Frame

Week 0, week 30

Title

Change in Calcitonin

Description

Time Frame

Week 0, week 30

Title

Change in Pulse

Description

Time Frame

Week 0, week 30

Title

Change in Electrocardiogram

Description

Time Frame

Week 0, week 30

Title

Change in Physical Examination: General Appearance

Description

Time Frame

Week -2, week 30

Title

Change in Physical Examination: Central and Peripheral Nervous System

Description

Time Frame

Week -2, week 30

Title

Change in Physical Examination: Cardiovascular System

Description

Time Frame

Week -2, week 30

Title

Change in Physical Examination: Gastrointestinal System Including Mouth

Description

Time Frame

Week -2, week 30

Title

Change in Physical Examination: Skin

Description

Time Frame

Week -2, week 30

Title

Change in Physical Examination: Respiratory System

Description

Time Frame

Week -2, week 30

Title

Change in Physical Examination: Lymph Node Palpation

Description

Time Frame

Week -2, week 30

Title

Change in Physical Examination: Thyroid Gland

Description

Time Frame

Week -2, week 30

Title

Change in Fundoscopy

Description

Time Frame

Week 0, week 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial Male or female, above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age equal to or above 20 years at the time of signing informed consent Diagnosed with type 2 diabetes mellitus HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive) Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (equal to or above 1500 mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of screening. All medications in compliance with current local label Exclusion Criteria: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol 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 insulin treatment for a maximum of 14 days prior to the day of screening is allowed Subjects with alanine aminotransferase above 2.5 x upper normal limit 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 Class IV Planned coronary, carotid or peripheral artery revascularisation known on the day of screening Renal impairment measured as estimated Glomerular Filtration Rate value of eGFR below 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry for serum creatinine measured 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 Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Andalusia

State/Province

Alabama

ZIP/Postal Code

36420

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85308

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85037

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85283

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72211

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lincoln

State/Province

California

ZIP/Postal Code

95648

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Edgewater

State/Province

Florida

ZIP/Postal Code

32132

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751-4422

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Woodstock

State/Province

Georgia

ZIP/Postal Code

30189-4255

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Hutchinson

State/Province

Kansas

ZIP/Postal Code

67502-1131

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Troy

State/Province

Michigan

ZIP/Postal Code

48098

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jefferson City

State/Province

Missouri

ZIP/Postal Code

65109

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Smithtown

State/Province

New York

ZIP/Postal Code

11787

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

West Seneca

State/Province

New York

ZIP/Postal Code

14224

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28226

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Gastonia

State/Province

North Carolina

ZIP/Postal Code

28054

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Kinston

State/Province

North Carolina

ZIP/Postal Code

28501

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557-4346

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73069

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Beaver

State/Province

Pennsylvania

ZIP/Postal Code

15009

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

McMurray

State/Province

Pennsylvania

ZIP/Postal Code

15317

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15243

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012-4637

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75208

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77081

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Irving

State/Province

Texas

ZIP/Postal Code

75061-2210

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Shavano Park

State/Province

Texas

ZIP/Postal Code

78231

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Victoria

State/Province

Texas

ZIP/Postal Code

77901

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Murray

State/Province

Utah

ZIP/Postal Code

84123

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23321

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Olympia

State/Province

Washington

ZIP/Postal Code

98502

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Saint Stefan

ZIP/Postal Code

8511

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1060

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6H 2L4

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 3P4

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6S 0C6

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T 0G1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Etobicoke

State/Province

Ontario

ZIP/Postal Code

M9R 4E1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Smiths Falls

State/Province

Ontario

ZIP/Postal Code

K7A 4W8

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 3L9

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Kanagawa

ZIP/Postal Code

232-0064

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Nagakute-shi, Aichi

ZIP/Postal Code

480-1195

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Suita-shi, Osaka

ZIP/Postal Code

565-0853

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

160-0008

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Hamar

ZIP/Postal Code

2317

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Hoenefoss

ZIP/Postal Code

3515

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Namsos

ZIP/Postal Code

7801

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Olso

ZIP/Postal Code

0953

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Oslo

ZIP/Postal Code

0176

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Skedsmokorset

ZIP/Postal Code

NO-2020

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Stavanger

ZIP/Postal Code

4005

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

Novo Nordisk Investigational Site

City

Barnaul

ZIP/Postal Code

656045

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630099

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

191119

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

194358

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

St. Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

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

30833170

Citation

Zinman B, Bhosekar V, Busch R, Holst I, Ludvik B, Thielke D, Thrasher J, Woo V, Philis-Tsimikas A. Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2019 May;7(5):356-367. doi: 10.1016/S2213-8587(19)30066-X. Epub 2019 Mar 1. Erratum In: Lancet Diabetes Endocrinol. 2019 Mar 11;: Lancet Diabetes Endocrinol. 2019 Aug;7(8):e20. Lancet Diabetes Endocrinol. 2019 Nov;7(11):e22.

Results Reference

result

Learn more about this trial

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus

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Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus (SUSTAIN 9)

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