Clinical trial NCT03552757: Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity
Official title: Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Overweight
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-06-12
Enrollment: 1210
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 look at the change in the participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years


Eligibility criteria: Inclusion Criteria:

* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Body Mass Index (BMI) greater than or equal to 27 kg/m\^2 '
* History of at least one self-reported unsuccessful dietary effort to lose body weight
* Diagnosed with type 2 diabetes (haemoglobin A1c 7-10% (53-86 mmol/mol) (both inclusive)) 180 days or longer prior to the day of screening

Exclusion Criteria:

* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 mL/min/1.73 m\^2 (less than 60 ml/min/1.73 m\^2 in subjects treated with Sodium-glucose Cotransporter 2 Inhibitors) according to chronic kidney disease (CKD)-Epidemiology Collaboration (EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at 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 (e.g. optometrist) within the past 90 days prior to screening or in the period between screening and randomisation

Primary outcomes:
measure: Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo
timeFrame: Baseline (week 0) to week 68
measure: Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo
timeFrame: At week 68
Secondary outcomes:
measure: Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg
timeFrame: Baseline (week 0) to week 68
measure: Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg
timeFrame: At week 68
measure: Change in Waist Circumference
timeFrame: Baseline (week 0) to week 68
measure: Change in Body Weight (Kg)
timeFrame: Baseline (week 0) to week 68
measure: Change in BMI
timeFrame: Baseline (week 0) to week 68
measure: Participants Who Achieve (Yes/no): Body Weight Reduction ≥10%
timeFrame: At week 68
measure: Participants Who Achieve (Yes/no): Body Weight Reduction ≥15%
timeFrame: At week 68
measure: Participants Who Achieve (Yes/no): Body Weight Reduction ≥20%
timeFrame: At week 68
measure: Change in HbA1c (%)
timeFrame: Baseline (week 0) to week 68
measure: Change in HbA1c (mmol/Mol)
timeFrame: Baseline (week 0) to week 68
measure: Change in FPG (mg/dL)
timeFrame: Baseline (week 0) to week 68
measure: Change in Fasting Serum Insulin
timeFrame: Baseline (week 0) to week 68
measure: Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol)
timeFrame: At week 68
measure: Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)
timeFrame: At week 68
measure: Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0%
timeFrame: At week 68
measure: Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0%
timeFrame: At week 68
measure: Change in Systolic Blood Pressure
timeFrame: Baseline (week 0) to week 68
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline (week 0) to week 68
measure: Change in Total Cholesterol
timeFrame: Baseline (week 0) to week 68
measure: Change in HDL Cholesterol
timeFrame: Baseline (week 0) to week 68
measure: Change in LDL Cholesterol
timeFrame: Baseline (week 0) to week 68
measure: Change in VLDL Cholesterol
timeFrame: Baseline (week 0) to week 68
measure: Change in Free Fatty Acids
timeFrame: Baseline (week 0) to week 68
measure: Change in Triglycerides
timeFrame: Baseline (week 0) to week 68
measure: Change in hsCRP
timeFrame: Baseline (week 0) to week 68
measure: Change in PAI-1 Activity
timeFrame: Baseline (week 0) to week 68
measure: Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score)
timeFrame: Baseline (week 0) to week 68
measure: Change in SF-36 (All Scores Except Physical Functioning)
timeFrame: Baseline (week 0) to week 68
measure: Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score)
timeFrame: Baseline (week 0) to week 68
measure: Change in IWQOL-Lite for CT (All Scores Except Physical Function)
timeFrame: Baseline (week 0) to week 68
measure: Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score
timeFrame: At week 68
measure: Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score
timeFrame: At week 68
measure: Number of TEAEs - Semaglutide 2.4 mg Versus Placebo
timeFrame: Week 0 to week 75
measure: Number of SAEs - Semaglutide 2.4 mg Versus Placebo
timeFrame: Week 0 to week 75
measure: Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo
timeFrame: Week 0 to week 75
measure: Change in Pulse - Semaglutide 2.4 mg Versus Placebo
timeFrame: Baseline (week 0) to week 68
measure: Change in Amylase - Semaglutide 2.4 mg Versus Placebo
timeFrame: Baseline (week 0) to week 68
measure: Change in Lipase - Semaglutide 2.4 mg Versus Placebo
timeFrame: Baseline (week 0) to week 68
measure: Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo
timeFrame: Baseline (week 0) to week 68
Other outcomes:
Locations:
city: Buena Park
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Concord
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Fresno
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Lomita
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Mission Hills
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Spring Valley
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Tarzana
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Golden
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tampa
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Alpharetta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: West Des Moines
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Topeka
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Minneapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: Olive Branch
country: United States
facility: Novo Nordisk Investigational Site
state: Mississippi
city: Butte
country: United States
facility: Novo Nordisk Investigational Site
state: Montana
city: Lawrenceville
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Chapel Hill
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Wadsworth
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Anderson
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Shavano Park
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Saint George
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Winchester
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Olympia
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Caba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Chacabuco
country: Argentina
facility: Novo Nordisk Investigational Site
city: Córdoba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Mendoza
country: Argentina
facility: Novo Nordisk Investigational Site
city: Santiago del Estero
country: Argentina
facility: Novo Nordisk Investigational Site
city: Calgary
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
city: Mount Pearl
country: Canada
facility: Novo Nordisk Investigational Site
state: Newfoundland and Labrador
city: Concord
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: London
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Stoney Creek
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
city: St-Marc-des-Carrières
country: Canada
facility: Novo Nordisk Investigational Site
state: Quebec
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: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Lingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Münster
country: Germany
facility: Novo Nordisk Investigational Site
city: Rehlingen-Siersburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Schweinfurt
country: Germany
facility: Novo Nordisk Investigational Site
city: Stuttgart
country: Germany
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Haidari-Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Thessaloniki
country: Greece
facility: Novo Nordisk Investigational Site
city: Thessaloniki
country: Greece
facility: Novo Nordisk Investigational Site
city: Thessaloniki
country: Greece
facility: Novo Nordisk Investigational Site
city: Thessaloniki
country: Greece
facility: Novo Nordisk Investigational Site
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Kochi
country: India
facility: Novo Nordisk Investigational Site
state: Kerala
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: New Dehli
country: India
facility: Novo Nordisk Investigational Site
state: New Delhi
city: Jaipur
country: India
facility: Novo Nordisk Investigational Site
state: Rajasthan
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Coimbatore
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
state: West Bengal
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
state: West Bengal
city: New Delhi
country: India
facility: Novo Nordisk Investigational Site
city: Secunderabad
country: India
facility: Novo Nordisk Investigational Site
city: Chiba-shi, Chiba
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Ibaraki
country: Japan
facility: Novo Nordisk Investigational Site
city: Kashiwara-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Mitaka-shi, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: San Juan
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Barnaul
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Tomsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Brits
country: South Africa
facility: Novo Nordisk Investigational Site
state: North West
city: Almeria
country: Spain
facility: Novo Nordisk Investigational Site
city: Córdoba
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Málaga
country: Spain
facility: Novo Nordisk Investigational Site
city: San Cristóbal de La Laguna
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Valladolid
country: Spain
facility: Novo Nordisk Investigational Site
city: Dubai
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Dubai
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Dubai
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Hatta
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Umm Al Quwain
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Chester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Crewe
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Glasgow
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Harrogate, North Yorkshire
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leicester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Middlesbrough
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Soham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Stevenage
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Watford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Wellingborough
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Kushner RF, Calanna S, Davies M, Dicker D, Garvey WT, Goldman B, Lingvay I, Thomsen M, Wadden TA, Wharton S, Wilding JPH, Rubino D. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020 Jun;28(6):1050-1061. doi: 10.1002/oby.22794.
citation: Davies M, Faerch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021 Mar 13;397(10278):971-984. doi: 10.1016/S0140-6736(21)00213-0. Epub 2021 Mar 2.
citation: O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.