Clinical trial NCT03689374: A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-09-28
Enrollment: 2274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* 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 bolus insulin treatment for a maximum of 14 days prior to the day of screening is allowed
* 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

Primary outcomes:
measure: Change From Baseline in Glycated Haemoglobin (HbA1c)
timeFrame: Baseline (week 0), week 52
Secondary outcomes:
measure: Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52
timeFrame: From randomization (week 0) up to week 52
measure: 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
timeFrame: From randomization (week 0) up to week 52
measure: Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52
timeFrame: From randomization (week 0) to week 52
measure: 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
timeFrame: From randomization (week 0) to week 52
measure: 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
timeFrame: From randomization (week 0) to week 52
measure: Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52
timeFrame: From randomization (week 0) to week 52
measure: Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52
timeFrame: From randomization (week 0) to week 52
measure: Daily Basal Insulin Dose at Week 52
timeFrame: At week 52
measure: Total Daily Insulin Dose at Week 52
timeFrame: At week 52
measure: Change From Baseline to Week 52 in Body Weight (Kilogram (kg))
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP)
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals)
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline to Week 52 in Body Mass Index (BMI)
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline to Week 52 in Waist Circumference
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline)
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline)
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline to Week 52 in Pulse Rate
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains
timeFrame: Baseline (week 0), week 52
measure: Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains
timeFrame: Baseline (week 0), week 52
Other outcomes:
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city: Pretoria
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state: Gauteng
city: Pretoria
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city: Durban
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city: Durban
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city: Córdoba
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city: Fuenlabrada - Madrid
country: Spain
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city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Málaga
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city: Palma de Mallorca
country: Spain
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city: Segovia
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city: Sevilla
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facility: Novo Nordisk Investigational Site
city: Adana
country: Turkey
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city: Istanbul
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facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
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facility: Novo Nordisk Investigational Site
city: Izmir
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facility: Novo Nordisk Investigational Site
city: Trabzon
country: Turkey
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Kellerer M, Kaltoft MS, Lawson J, Nielsen LL, Strojek K, Tabak O, Jacob S. Effect of once-weekly semaglutide versus thrice-daily insulin aspart, both as add-on to metformin and optimized insulin glargine treatment in participants with type 2 diabetes (SUSTAIN 11): A randomized, open-label, multinational, phase 3b trial. Diabetes Obes Metab. 2022 Sep;24(9):1788-1799. doi: 10.1111/dom.14765. Epub 2022 Jun 29.