Clinical trial NCT03191396: Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2017-06-19
Enrollment: 577
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: Week 0, week 30
Secondary outcomes:
measure: Change in Body Weight (kg)
timeFrame: Week 0, week 30
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Week 0, week 30
measure: Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile
timeFrame: Week 0, week 30
measure: Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals)
timeFrame: Week 0, week 30
measure: Change in Fasting Blood Lipids: Total Cholesterol
timeFrame: Week 0, week 30
measure: Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol
timeFrame: Week 0, week 30
measure: Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol
timeFrame: Week 0, week 30
measure: Change in Fasting Blood Lipids: Triglycerides
timeFrame: Week 0, week 30
measure: Change in Body Mass Index (BMI)
timeFrame: Week 0, week 30
measure: Change in Waist Circumference
timeFrame: Week 0, week 30
measure: Change in Systolic Blood Pressure
timeFrame: Week 0, week 30
measure: Change in Diastolic Blood Pressure
timeFrame: Week 0, week 30
measure: Change in Body Weight (%)
timeFrame: Week 0, week 30
measure: Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target
timeFrame: After 30 weeks of treatment
measure: Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target
timeFrame: After 30 weeks of treatment
measure: Subjects Who Achieve Weight Loss Above or Equal to 3%
timeFrame: After 30 weeks of treatment
measure: Subjects Who Achieve Weight Loss Above or Equal to 5%
timeFrame: After 30 weeks of treatment
measure: Subjects Who Achieve Weight Loss Above or Equal to 10%
timeFrame: After 30 weeks of treatment
measure: Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain
timeFrame: After 30 weeks of treatment
measure: Subjects Who Achieve HbA1c Reduction Above or Equal to 1%
timeFrame: After 30 weeks of treatment
measure: Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3%
timeFrame: After 30 weeks of treatment
measure: Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5%
timeFrame: After 30 weeks of treatment
measure: Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10%
timeFrame: After 30 weeks of treatment
measure: Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains
timeFrame: Week 0, week 30
measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately
timeFrame: Week 0, week 30
measure: Number of Treatment-emergent Adverse Events (TEAE)
timeFrame: Week 0 to week 35
measure: Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
timeFrame: Week 0 to week 35
measure: Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes
timeFrame: Week 0 to week 35
measure: Change in Haematology - Haemoglobin
timeFrame: Week 0, week 30
measure: Change in Haematology - Haematocrit
timeFrame: Week 0, week 30
measure: Change in Haematology - Thrombocytes and Leukocytes
timeFrame: Week 0, week 30
measure: Change in Haematology - Erythrocytes
timeFrame: Week 0, week 30
measure: Change in Biochemistry - Calcium, Pottassium and Sodium
timeFrame: Week 0, week 30
measure: Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase.
timeFrame: Week 0, week 30
measure: Change in Biochemistry - Amylase and Lipase
timeFrame: Week 0, week 30
measure: Change in Biochemistry - Creatinine and Bilirubin
timeFrame: Week 0, week 30
measure: Change in Biochemistry - Albumin
timeFrame: Week 0, week 30
measure: Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR).
timeFrame: Week 0, week 30
measure: Change in Calcitonin
timeFrame: Week 0, week 30
measure: Change in Pulse Rate
timeFrame: Week 0, week 30
Other outcomes:
Locations:
city: Burgas
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Dupnitsa
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Lukovit
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Madan
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Petrich
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Ruse
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sliven
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Vratsa
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Brno
country: Czechia
facility: Novo Nordisk Investigational Site
city: Brno
country: Czechia
facility: Novo Nordisk Investigational Site
city: Nachod
country: Czechia
facility: Novo Nordisk Investigational Site
city: Praha 10
country: Czechia
facility: Novo Nordisk Investigational Site
city: Praha 4
country: Czechia
facility: Novo Nordisk Investigational Site
city: Helsinki
country: Finland
facility: Novo Nordisk Investigational Site
city: Jyväskylä
country: Finland
facility: Novo Nordisk Investigational Site
city: Kuusamo
country: Finland
facility: Novo Nordisk Investigational Site
city: Lahti
country: Finland
facility: Novo Nordisk Investigational Site
city: Oulu
country: Finland
facility: Novo Nordisk Investigational Site
city: Rauma
country: Finland
facility: Novo Nordisk Investigational Site
city: Turku
country: Finland
facility: Novo Nordisk Investigational Site
city: Varkaus
country: Finland
facility: Novo Nordisk Investigational Site
city: Béziers
country: France
facility: Novo Nordisk Investigational Site
city: Dambach-la-ville
country: France
facility: Novo Nordisk Investigational Site
city: DIJON cedex
country: France
facility: Novo Nordisk Investigational Site
city: LA ROCHELLE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Le Coudray
country: France
facility: Novo Nordisk Investigational Site
city: Le Creusot
country: France
facility: Novo Nordisk Investigational Site
city: Nantes
country: France
facility: Novo Nordisk Investigational Site
city: Obernai
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: PERPIGNAN cedex
country: France
facility: Novo Nordisk Investigational Site
city: Schiltigheim
country: France
facility: Novo Nordisk Investigational Site
city: Strasbourg
country: France
facility: Novo Nordisk Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: Novo Nordisk Investigational Site
city: Venissieux
country: France
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Essen
country: Germany
facility: Novo Nordisk Investigational Site
city: Falkensee
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Saint Ingbert-Oberwürzbach
country: Germany
facility: Novo Nordisk Investigational Site
city: Stuttgart
country: Germany
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Nagykanizsa
country: Hungary
facility: Novo Nordisk Investigational Site
city: Pécs
country: Hungary
facility: Novo Nordisk Investigational Site
city: Siófok
country: Hungary
facility: Novo Nordisk Investigational Site
city: Szolnok
country: Hungary
facility: Novo Nordisk Investigational Site
city: Tatabánya
country: Hungary
facility: Novo Nordisk Investigational Site
city: Zalaegerszeg
country: Hungary
facility: Novo Nordisk Investigational Site
city: Bergamo
country: Italy
facility: Novo Nordisk Investigational Site
city: Como
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Pavia
country: Italy
facility: Novo Nordisk Investigational Site
city: Rome
country: Italy
facility: Novo Nordisk Investigational Site
city: Lublin
country: Poland
facility: Novo Nordisk Investigational Site
city: Lublin
country: Poland
facility: Novo Nordisk Investigational Site
city: Szczecin
country: Poland
facility: Novo Nordisk Investigational Site
city: Celje
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Jesenice
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Koper
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Ljubljana
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Alcorcón
country: Spain
facility: Novo Nordisk Investigational Site
city: Almería
country: Spain
facility: Novo Nordisk Investigational Site
city: La Roca del Vallés
country: Spain
facility: Novo Nordisk Investigational Site
city: Palma de Mallorca
country: Spain
facility: Novo Nordisk Investigational Site
city: Valladolid
country: Spain
facility: Novo Nordisk Investigational Site
city: Vic (Barcelona)
country: Spain
facility: Novo Nordisk Investigational Site
city: Kristianstad
country: Sweden
facility: Novo Nordisk Investigational Site
city: Lund
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Ängelholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Örebro
country: Sweden
facility: Novo Nordisk Investigational Site
city: Blackpool
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bristol
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Coventry
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Crewe
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Faringdon
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Hinckley
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Northwood
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Norwich
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Nuneaton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Rhyl
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Rotherham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sidcup
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Southampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: St Helens
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Truro
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Watford
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
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.
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.