Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity (STEP 2)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Semaglutide 2.4 mg; Drug: Placebo II (Semaglutide); Drug: Placebo I (Semaglutide); Drug: Semaglutide 1.0 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03552757

NN9536-4374

U1111-1200-8148 (Other Identifier)

2017-003414-10 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 1,210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,210 participants in 3 patient groups, including a placebo group

Semaglutide 1.0 mg

Experimental group

Description:

Participants will receive semaglutide 1.0 mg and semaglutide placebo I during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Treatment:

Drug: Placebo I (Semaglutide)

Drug: Semaglutide 1.0 mg

Semaglutide 2.4 mg

Experimental group

Description:

Participants will receive semaglutide 2.4 mg and semaglutide placebo II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Treatment:

Drug: Semaglutide 2.4 mg

Drug: Placebo II (Semaglutide)

Semaglutide placebo I/II

Placebo Comparator group

Description:

Participants will receive semaglutide placebo I and II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Treatment:

Drug: Placebo I (Semaglutide)

Drug: Placebo II (Semaglutide)