Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: A 56 Week Randomised, Double-blind, Placebo-controlled, Three Armed Parallel Group, Multi-centre, Multinational Trial With a 12 Week Observational Follow-up Period
Change (%) From Baseline in Body Weight (Fasting) (percent change), Week 0, week 56. Liraglutide 3.0 mg: -5.9; Liraglutide 1.8 mg: -4.6; Liraglutide Placebo: -2.0.
As posted on ClinicalTrials.gov (NCT01272232), updated at source Dec 29, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Liraglutide 3.0 mgn=412 | Liraglutide 1.8 mgn=204 | Liraglutide Placebon=211 |
|---|---|---|
| -5.9(5.5) | -4.6(5.5) | -2.0(4.3) |
| Measure | Liraglutide 3.0 mgn=412 | Liraglutide 1.8 mgn=204 | Liraglutide Placebon=211 |
|---|---|---|---|
| Yes | 49.9 | 35.6 | 13.8 |
| No | 50.1 | 64.4 | 86.2 |
| Measure | Liraglutide 3.0 mgn=412 | Liraglutide 1.8 mgn=204 | Liraglutide Placebon=211 |
|---|---|---|---|
| Yes | 23.4 | 14.4 | 4.3 |
| No | 76.6 | 85.6 | 95.7 |
Percent of participants affected, Adverse events were recorded for up to 68 weeks.. The most common events the registry lists.
| Event | Liraglutide 3.0 mg | Liraglutide 1.8 mg | Liraglutide Placebo |
|---|---|---|---|
| Any serious event | 8.8% | 8.6% | 6.1% |
| Hypoglycaemia | 44.3% | 40% | 27.8% |
| Nausea | 32.7% | 31.4% | 13.7% |
| Diarrhoea | 25.6% | 17.6% | 12.7% |
| Nasopharyngitis | 20.9% | 16.2% | 19.3% |
| Constipation | 16.1% | 9.5% | 6.1% |
| Vomiting | 15.6% | 10% | 5.7% |
| Headache | 15.6% | 12.4% | 13.7% |
| Back pain | 10% | 12.9% | 9.4% |
| Lipase increased | 11.8% | 10.5% | 6.6% |
| Dyspepsia | 11.1% | 6.7% | 2.4% |
| Upper respiratory tract infection | 9.5% | 11% | 8.5% |
| Decreased appetite | 9.5% | 11% | 1.9% |
| Sinusitis | 3.8% | 7.1% | 8.5% |
| Fatigue | 8.3% | 5.2% | 3.3% |
| Arthralgia | 7.1% | 8.1% | 5.7% |
| Influenza | 5.2% | 5.7% | 7.1% |
| Dizziness | 7.1% | 4.8% | 2.8% |
| Abdominal pain upper | 3.6% | 6.7% | 0.9% |
| Abdominal distension | 6.2% | 4.8% | 1.4% |
| Abdominal pain | 6.2% | 1.9% | 4.2% |
| Urinary tract infection | 4.5% | 6.2% | 5.7% |
| Injection site haematoma | 4.5% | 1.9% | 5.7% |
| Bronchitis | 3.1% | 5.7% | 5.2% |
| Pain in extremity | 3.8% | 5.7% | 4.7% |
| Cough | 4.3% | 5.7% | 3.8% |
| Liraglutide 3.0 mgn=412 | Liraglutide 1.8 mgn=204 | Liraglutide Placebon=211 |
|---|---|---|
| -1.3(0.9) | -1.1(1.0) | -0.3(0.9) |
| Measure | Liraglutide 3.0 mgn=412 | Liraglutide 1.8 mgn=204 | Liraglutide Placebon=211 |
|---|---|---|---|
| Yes | 69.2 | 66.7 | 27.2 |
| No | 30.8 | 33.3 | 72.8 |
| Measure | Liraglutide 3.0 mgn=412 | Liraglutide 1.8 mgn=204 | Liraglutide Placebon=211 |
|---|---|---|---|
| Yes | 56.5 | 45.6 | 15.0 |
| No | 43.5 | 54.4 | 85.0 |
| Liraglutide 3.0 mgn=412 | Liraglutide 1.8 mgn=204 | Liraglutide Placebon=211 |
|---|---|---|
| -6.1(6.5) | -4.8(5.6) | -2.7(5.4) |
| Liraglutide 3.0 mgn=324 | Liraglutide 1.8 mgn=164 | Liraglutide Placebon=140 |
|---|---|---|
| -4.7(5.0) | -3.6(5.7) | -2.7(5.8) |
| Liraglutide 3.0 mgn=324 | Liraglutide 1.8 mgn=164 | Liraglutide Placebon=140 |
|---|---|---|
| 2.3(2.9) | 2.0(2.9) | -0.1(2.2) |
| Liraglutide 3.0 mgn=324 | Liraglutide 1.8 mgn=164 | Liraglutide Placebon=140 |
|---|---|---|
| -5.7(6.3) | -4.4(6.0) | -3.2(6.8) |
| Liraglutide 3.0 mgn=324 | Liraglutide 1.8 mgn=164 | Liraglutide Placebon=140 |
|---|---|---|
| 1.21(3.94) | 1.02(3.55) | -0.22(3.23) |
| Measure | Liraglutide 3.0 mgn=422 | Liraglutide 1.8 mgn=210 | Liraglutide Placebon=212 |
|---|---|---|---|
| Minor | 34 | 46 | 13 |
| ADA: Severe | 1 | 2 | 0 |
| ADA: Documented, symptomatic | 87 | 95 | 31 |
| ADA: Asymptomatic | 151 | 142 | 46 |
| ADA: Probable, symptomatic | 2 | 2 | 1 |
| ADA: Relative | 17 | 16 | 5 |
| ADA: Unclassifiable | 14 | 7 | 3 |
This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the potential of liraglutide to induce and maintain weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added onto subject's pre-trial background diabetes treatment of either diet and exercise only or single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea \[SU\] or glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration of the trial will be 56 weeks followed by a 12 week observational follow-up period.
Inclusion Criteria: * Informed consent obtained * Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, sulphonylurea, glitazone as single agent therapy or a combination of the previously mentioned compounds * HbA1c 7.0-10.0% (both inclusive) * Body Mass Index (BMI) at least 27.0 kg/m\^2 * Stable body weight * Preceding failed dietary effort Exclusion Criteria: * Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months * Known proliferative retinopathy or maculopathy * History of acute or chronic pancreatitis * Obesity induced by drug treatment * Use of approved weight lowering pharmacotherapy * Previous surgical treatment of obesity * History of major depressive disorder or suicide attempt * Uncontrolled hypertension (systolic blood pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg) * Screening calcitonin of 50 ng/L or above * Familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC) * Personal history of non-familial medullary thyroid carcinoma
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.