Skip to content

Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name SUSTAIN 10

NCTNCT03191396 (opens ClinicalTrials.gov in a new tab)Other idNN9535-4339Other id2016-004965-22Other idU1111-1190-5868Other id2016
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
577 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
12 countries

Bulgaria, Czechia, Finland, France, Germany, Hungary, Italy, Poland, Slovenia, Spain, Sweden, United Kingdom

Start
27 Jun 2017
Primary completion
9 Jul 2018
Completion
13 Aug 2018
First posted
19 Jun 2017
Last update posted
15 Oct 2019
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 3

    SUSTAIN 10

    NCT03191396

    27 Jun 2017 to 13 Aug 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SemaglutideDrug
  • LiraglutideDrug

Arms2

  • Experimental

    Semaglutide

    Half the study participants are randomised to receive semaglutide

  • Active comparator

    Liraglutide

    Half the study participants are randomised to receive liraglutide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c

    Time frame · Week 0, week 30

    Registry description

    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 outcomes(20)

  1. Change in Body Weight (kg)

    Time frame · Week 0, week 30

    Registry description

    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.

  2. Change in Fasting Plasma Glucose (FPG)

    Time frame · Week 0, week 30

    Registry description

    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.

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

    Time frame · Week 0, week 30

    Registry description

    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.

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

    Time frame · Week 0, week 30

    Registry description

    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.

  5. Change in Fasting Blood Lipids: Total Cholesterol

    Time frame · Week 0, week 30

    Registry description

    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.

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

    Time frame · Week 0, week 30

    Registry description

    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.

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

    Time frame · Week 0, week 30

    Registry description

    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.

  8. Change in Fasting Blood Lipids: Triglycerides

    Time frame · Week 0, week 30

    Registry description

    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.

  9. Change in Body Mass Index (BMI)

    Time frame · Week 0, week 30

    Registry description

    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.

  10. Change in Waist Circumference

    Time frame · Week 0, week 30

    Registry description

    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.

  11. Change in Systolic Blood Pressure

    Time frame · Week 0, week 30

    Registry description

    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.

  12. Change in Diastolic Blood Pressure

    Time frame · Week 0, week 30

    Registry description

    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.

  13. Change in Body Weight (%)

    Time frame · Week 0, week 30

    Registry description

    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.

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

    Time frame · After 30 weeks of treatment

    Registry description

    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.

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

    Time frame · After 30 weeks of treatment

    Registry description

    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.

  16. Subjects Who Achieve Weight Loss Above or Equal to 3%

    Time frame · After 30 weeks of treatment

    Registry description

    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.

  17. Subjects Who Achieve Weight Loss Above or Equal to 5%

    Time frame · After 30 weeks of treatment

    Registry description

    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.

  18. Subjects Who Achieve Weight Loss Above or Equal to 10%

    Time frame · After 30 weeks of treatment

    Registry description

    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.

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

    Time frame · After 30 weeks of treatment

    Registry description

    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.

  20. Subjects Who Achieve HbA1c Reduction Above or Equal to 1%

    Time frame · After 30 weeks of treatment

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Week 0, week 30

Change in HbA1c

GroupValue (Percentage of glycosylated haemoglobin)Spread
Semaglutide 1.0 mg-1.70.9
Liraglutide 1.2 mg-1.11.0
Secondary and other outcome results(7)
Secondary outcomeMean· Week 0, week 30

Change in Body Weight (kg)

GroupValue (kg)Spread
Semaglutide 1.0 mg-5.84.7
Liraglutide 1.2 mg-2.04.1
Secondary outcomeMean· Week 0, week 30

Change in Fasting Plasma Glucose (FPG)

GroupValue (mmol/L)Spread
Semaglutide 1.0 mg-2.652.19
Liraglutide 1.2 mg-1.462.42
Secondary outcomeMean· Week 0, week 30

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

GroupValue (mmol/L)Spread
Semaglutide 1.0 mg-3.02.0
Liraglutide 1.2 mg-2.12.3
Secondary outcomeMean· Week 0, week 30

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

GroupValue (mmol/L)Spread
Semaglutide 1.0 mg-1.01.8
Liraglutide 1.2 mg-0.41.9
Secondary outcomeGeometric mean· Week 0, week 30

Change in Fasting Blood Lipids: Total Cholesterol

GroupValue (ratio)Spread
Semaglutide 1.0 mg0.9616.8
Liraglutide 1.2 mg0.9816.9
Secondary outcomeGeometric mean· Week 0, week 30

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

GroupValue (ratio)Spread
Semaglutide 1.0 mg0.9928.3
Liraglutide 1.2 mg0.9927.2
Secondary outcomeGeometric mean· Week 0, week 30

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

GroupValue (ratio)Spread
Semaglutide 1.0 mg1.0114.6
Liraglutide 1.2 mg0.9912.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Semaglutide 1.0 mgSubjects received 1.0 mg semaglutide once-weekly for 30 weeks (including 8-week dose escalation period). Semaglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once weekly on the same weekday. Subjects started semaglutide at 0.25 mg and were dose escalated in 4-week increments until the final maintenance dose of 1.0 mg was reached (i.e. 0.25 mg from week 0 to week 4, 0.5 mg from week 4 to week 8 and 1.0 mg from week 8 to week 30). Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).0 / 28917 / 289139 / 289
Liraglutide 1.2 mgSubjects received 1.2 mg liraglutide once-daily for 30 weeks (including 1-week dose escalation period). Liraglutide was administered subcutaneously by injections in the thigh, abdomen or upper arm once-daily and the time of injection was to be consistent from one day to another. Subjects started liraglutide at 0.6 mg for 1 week and then were dose escalated to the maintenance dose of 1.2 mg. Subjects also continued their OAD pre-trial background medication (i.e. metformin, SGLT-2 inhibitors, sulphonyl ureas, or combinations of these).0 / 28722 / 287113 / 287

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

13 results

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).

Capehorn et al. 2020Diabetes & metabolismcited by 308

PMID 31539622DOI 10.1016/j.diabet.2019.101117PUB-31539622

Full text at the publisher13 results
Publisher pageSee results (13)

More studies

1 study on this page

PubMed tag: none · 2020

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.

Capehorn et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 10

PMID 32193837PMC7193006DOI 10.1007/s13300-020-00796-zPUB-32193837

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.