Phase 2
Completed N=415
A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide
Source: ClinicalTrials.gov NCT00696657 ↗Enrolled (actual)
415
Serious AEs
2.0%
Results posted
Sep 2018
Primary outcomePrimary: HbA1c — -0.5; -0.6; -0.9; -1.0 Percentage (%) of HbA1c — p=<0.0001
Summary
This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c |
-0.5; -0.6; -0.9; -1.0; -1.4; -1.4 | <0.0001 sig |
| SECONDARY Percentage of Subjects With an Adverse Events |
43.5; 59.6; 55.8; 72.9; 85.7; 72.1 | — |
| SECONDARY Percentage of Subjects With Hypoglycaemic Episode |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in ECG |
42; 33; 37; 34; 31; 28 | — |
| SECONDARY Change From Baseline in Vital Signs (Pulse) |
0.5; -0.0; 0.5; 1.5; 1.5; 2.9 | — |
| SECONDARY Change From Baseline in Vital Signs (Blood Pressure; SBP) |
-3.2; 3.3; -2.5; -3.6; -6.7; -7.7 | — |
| SECONDARY Change From Baseline in Vital Signs (Blood Pressure; DBP) |
-2.3; 1.5; -0.4; -1.5; -1.5; -2.3 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils) |
-0.0; 0.0; -0.0; 0.0; -0.0; -0.0 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils) |
-0.0; 0.0; -0.0; 0.0; -0.0; 0.0 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit) |
-0.01; -0.01; -0.01; 0.00; -0.01; -0.00 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin) |
0.1; -0.4; -1.2; 2.8; -0.3; 1.5 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes) |
-0.1; 0.0; -0.1; 0.2; -0.0; -0.1 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes) |
0.1; 0.0; -0.0; 0.1; 0.1; 0.0 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils) |
0.1; 0.0; -0.1; 0.3; -0.1; 0.5 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes) |
9.0; 16.1; 10.8; 10.7; 5.4; 5.5 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes) |
-0.04; -0.06; -0.03; 0.08; -0.05; 0.03 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes) |
0.05; 0.04; -0.16; 0.59; 0.14; 0.41 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin) |
0.402; 0.130; -0.091; -0.177; 0.303; 0.607 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase) |
-0.52; -1.66; -2.37; -2.35; -1.39; -2.81 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST) |
-1.09; 1.23; 0.24; -1.81; -0.37; -2.60 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT) |
-2.41; 0.83; 0.68; -4.21; -2.13; -6.19 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin) |
0.7; -0.4; 0.6; 0.8; 0.7; 1.3 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total) |
0.0; -0.0; -0.0; -0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised) |
0.00; -0.01; -0.04; -0.01; -0.01; 0.01 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine) |
-1.02; 0.936; -0.349; -2.31; -0.658; -1.67 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium) |
0.07; 0.08; 0.06; -0.02; 0.04; -0.02 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium) |
0.1; 0.0; -0.1; -0.1; 0.4; 0.2 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea) |
-0.1; 0.1; -0.1; -0.4; -0.3; -0.5 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose) |
31; 26; 23; 35; 23; 28 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin) |
45; 45; 41; 45; 38; 39 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones) |
45; 47; 39; 46; 41; 41 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH) |
16; 13; 19; 11; 10; 11 | — |
| SECONDARY Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein) |
45; 47; 41; 44; 39; 40 | — |
| SECONDARY Change From Baseline in Calcitonin |
0.43; 0.48; -0.48; 0.62; 0.45; 0.87 | — |
| SECONDARY Percentage of Subjects Developing Anti-semaglutide Antibodies |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months
- Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months
- HbA1c: 7.0-10.0 % (both inclusive)
- Body weight between 60 kg and 110 kg
Exclusion Criteria
- Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any investigational drug, within the last three months
- Impaired liver or kidney function
- Proliferative retinopathy or maculopathy requiring acute treatment
- Clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension
- Recurrent major hypoglycaemia or hypoglycaemic unawareness
- Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)
Data sourced from ClinicalTrials.gov (NCT00696657). 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.