Phase 3
Completed N=1,210
Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity
Source: ClinicalTrials.gov NCT03552757 ↗Enrolled (actual)
1,210
Serious AEs
9.0%
Results posted
Aug 2021
Primary outcomePrimary: Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo — -9.9; -3.3; -10.7; -3.1 Percentage point of body weight — p=<0.0001
◆ Published Evidence
Highly cited
1,262citations · ~252 / year
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.
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
Linked Publications (5)
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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.
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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.
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Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials.
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Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials.
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Proteomic signatures reflect effects of semaglutide treatment for MASH.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo |
-9.9; -3.3; -10.7; -3.1 | <0.0001 sig |
| PRIMARY Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo |
267; 107; 121; 269; 257; 94 | <0.0001 sig |
| SECONDARY Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg |
-9.9; -7.2 | — |
| SECONDARY Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg |
267; 217; 121; 163 | — |
| SECONDARY Change in Waist Circumference |
-6.9; -9.7; -4.3 | — |
| SECONDARY Change in Body Weight (Kg) |
-7.1; -9.9; -3.4 | — |
| SECONDARY Change in BMI |
-2.6; -3.6; -1.2 | — |
| SECONDARY Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% |
109; 177; 31; 271; 211; 345 | — |
| SECONDARY Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% |
52; 100; 12; 328; 288; 364 | — |
| SECONDARY Participants Who Achieve (Yes/no): Body Weight Reduction ≥20% |
18; 51; 6; 362; 337; 370 | — |
| SECONDARY Change in HbA1c (%) |
-1.5; -1.7; -0.3 | — |
| SECONDARY Change in HbA1c (mmol/Mol) |
-16.9; -18.7; -3.4 | — |
| SECONDARY Change in FPG (mg/dL) |
-36.5; -37.9; -2.3 | — |
| SECONDARY Change in Fasting Serum Insulin |
0.94; 0.90; 0.93 | — |
| SECONDARY Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol) |
272; 299; 99; 104; 82; 275 | — |
| SECONDARY Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol) |
226; 257; 58; 150; 124; 316 | — |
| SECONDARY Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0% |
105; 170; 25; 271; 211; 349 | — |
| SECONDARY Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0% |
49; 98; 11; 327; 283; 363 | — |
| SECONDARY Change in Systolic Blood Pressure |
-3; -4; 0 | — |
| SECONDARY Change in Diastolic Blood Pressure |
-1; -2; -1 | — |
| SECONDARY Change in Total Cholesterol |
0.97; 0.99; 1.00 | — |
| SECONDARY Change in HDL Cholesterol |
1.06; 1.07; 1.04 | — |
| SECONDARY Change in LDL Cholesterol |
0.99; 1.00; 1.00 | — |
| SECONDARY Change in VLDL Cholesterol |
0.82; 0.80; 0.92 | — |
| SECONDARY Change in Free Fatty Acids |
0.85; 0.84; 1.01 | — |
| SECONDARY Change in Triglycerides |
0.81; 0.79; 0.92 | — |
| SECONDARY Change in hsCRP |
0.59; 0.50; 0.84 | — |
| SECONDARY Change in PAI-1 Activity |
1.21; 1.06; 1.42 | — |
| SECONDARY Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score) |
2.1; 2.8; 0.8 | — |
| SECONDARY Change in SF-36 (All Scores Except Physical Functioning) |
0.6; 0.8; 0.0; 0.4; 0.3; -0.4 | — |
| SECONDARY Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score) |
8.5; 11.4; 4.9 | — |
| SECONDARY Change in IWQOL-Lite for CT (All Scores Except Physical Function) |
7.6; 11.0; 4.4; 8.6; 9.6; 5.6 | — |
| SECONDARY Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score |
88; 111; 68; 282; 265; 297 | — |
| SECONDARY Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score |
107; 131; 83; 262; 245; 282 | — |
| SECONDARY Number of TEAEs - Semaglutide 2.4 mg Versus Placebo |
2197; 1388 | — |
| SECONDARY Number of SAEs - Semaglutide 2.4 mg Versus Placebo |
71; 53 | — |
| SECONDARY Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo |
51; 18 | — |
| SECONDARY Change in Pulse - Semaglutide 2.4 mg Versus Placebo |
2; 0 | — |
| SECONDARY Change in Amylase - Semaglutide 2.4 mg Versus Placebo |
1.24; 1.06 | — |
| SECONDARY Change in Lipase - Semaglutide 2.4 mg Versus Placebo |
1.41; 0.99 | — |
| SECONDARY Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo |
0.94; 0.96 | — |
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
Data sourced from ClinicalTrials.gov (NCT03552757) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.