NCT03689374|CompletedPhase 3ResultsFDA Drug

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

SUSTAIN 11

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

3 other identifiers

NN9535-4386U1111-1200-01642017-003219-20

Study Type

interventional

Target

2,274

Locations

19 countries

Sites

195

Timeline

RegisteredSep 2018

StartedOct 2018

CompletionFeb 2021

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

2,274

participants targeted

Target at P75+ for phase_3 diabetes-mellitus-type-2

Timeline

Completed

Started Oct 2018

Typical duration for phase_3 diabetes-mellitus-type-2

Geographic Reach

19 countries

195 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

September 27, 2018

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed

3 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2021

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

May 4, 2022

Completed

Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

2.4 years

First QC Date

September 27, 2018

Results QC Date

February 21, 2022

Last Update Submit

November 10, 2022

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (24)

Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52
From randomization (week 0) up to week 52
Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52
From randomization (week 0) up to week 52
Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52
From randomization (week 0) to week 52
Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52
From randomization (week 0) to week 52
Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52
From randomization (week 0) to week 52
+19 more secondary outcomes

Study Arms (2)

Semaglutide

EXPERIMENTAL

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

Drug: SemaglutideDrug: Insulin glargine U100

Insulin aspart

ACTIVE COMPARATOR

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

Drug: Insulin aspartDrug: Insulin glargine U100

Interventions

SemaglutideDRUG

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

Semaglutide

Insulin aspartDRUG

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

Insulin aspart

Insulin glargine U100DRUG

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

Insulin aspartSemaglutide

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

History or presence of pancreatitis (acute or chronic)
Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
Subjects presently classified as being in New York Heart Association Class IV
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (for example, optometrist) within the past 90 days prior to run-in

Contact the study team to confirm eligibility.