What NCT02505334 measured first
| Liraglutide 1.8 mgn=233 | Liraglutide 0.9 mgn=233 |
|---|---|
| -0.23(0.06) | 0.17(0.06) |
A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus
Change in Glycosylated Haemoglobin (HbA1c) (Week 26) (Percentage (%) of HbA1c), Week 0, Week 26. Liraglutide 1.8 mg: -0.23; Liraglutide 0.9 mg: 0.17.
As posted on ClinicalTrials.gov (NCT02505334), updated at source Sep 5, 2018. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| Liraglutide 1.8 mgn=233 | Liraglutide 0.9 mgn=233 |
|---|---|
| -0.23(0.06) | 0.17(0.06) |
Percent of participants affected, Liraglutide 1.8 mg treatment arm: Week 0 to week 52 (treatment period) + 7 days (follow-up period). Liraglutide 0.9 mg treatment arm: Week 0 to week 26 (treatment period) + 7 days (follow-up period).. The most common events the registry lists.
| Event | Liraglutide 1.8 mg | Liraglutide 0.9 mg |
|---|---|---|
| Any serious event | 3.4% | 1.3% |
| Viral upper respiratory tract infection | 28.3% | 18.9% |
| Diabetic retinopathy | 9.9% | 7.3% |
| Constipation | 7.3% | 2.1% |
| Lipase increased | 5.6% | 2.6% |
| Measure | Liraglutide 1.8 mgn=233 |
|---|---|
| Week 0: Baseline | 8.14(1.02) |
| Week 52: Change from baseline | -0.09(1.05) |
| Measure | Liraglutide 1.8 mgn=233 | Liraglutide 0.9 mgn=233 |
|---|---|---|
| Week 26 | 53 | 18 |
| Week 52 | 45 | not reported |
| Measure | Liraglutide 1.8 mgn=233 | Liraglutide 0.9 mgn=233 |
|---|---|---|
| Week 26 | 18 | 5 |
| Week 52 | 16 | not reported |
| Measure | Liraglutide 1.8 mgn=233 | Liraglutide 0.9 mgn=233 |
|---|---|---|
| Week 26 | 36 | 13 |
| Week 52 | 35 | not reported |
| Measure | Liraglutide 1.8 mgn=233 | Liraglutide 0.9 mgn=233 |
|---|---|---|
| Week 26 | 53 | 18 |
| Week 52 | 45 | not reported |
| Measure | Liraglutide 1.8 mgn=233 | Liraglutide 0.9 mgn=233 |
|---|---|---|
| Week 0: Before breakfast | 181.8(42.8) | 177.1(43.4) |
| Week 0: 90 minutes after start of breakfast | 262.6(65.0) | 266.5(70.0) |
| Week 0: Before lunch | 169.5(57.7) | 177.6(61.7) |
| Week 0: 90 minutes after start of lunch | 253.1(64.5) | 252.2(63.5) |
| Week 0: Before dinner | 173.4(59.2) | 169.7(56.5) |
| Week 0: 90 minutes after start of dinner | 254.3(66.2) | 249.5(63.2) |
| Week 0: At bedtime | 226.1(67.4) | 217.8(58.7) |
| Week 26: Before breakfast | 171.7(39.6) | 178.2(44.4) |
| Week 26: 90 minutes after start of breakfast | 247.2(64.6) | 258.2(63.7) |
| Week 26: Before lunch | 161.2(51.0) | 177.0(57.9) |
| Week 26: 90 minutes after start of lunch | 234.7(63.3) | 255.3(66.7) |
| Week 26: Before dinner | 162.3(47.5) | 168.6(57.5) |
| Measure | Liraglutide 1.8 mgn=233 | Liraglutide 0.9 mgn=233 |
|---|---|---|
| Baseline (week 0) | 217.9(46.7) | 217.7(46.8) |
| Change from baseline: week 26 | -14.5(39.0) | -0.6(45.0) |
| Change from baseline: week 52 | -8.9(43.7) | not reported |
| Measure | Liraglutide 1.8 mgn=233 | Liraglutide 0.9 mgn=233 |
|---|---|---|
| Week 0: Baseline | 81.7(38.7) | 81.6(38.6) |
| Week 26: Change from baseline | -8.4(43.8) | -1.5(39.5) |
| Week 52: Change from baseline | -6.3(44.4) | not reported |
| Measure | Liraglutide 1.8 mgn=233 | Liraglutide 0.9 mgn=233 |
|---|---|---|
| Week 0: Baseline | 172.5(38.7) | 172.0(38.3) |
| Week 26: Change from baseline | -8.4(36.7) | 1.0(33.7) |
| Week 52: Change from baseline | -1.2(39.0) | not reported |
| Measure | Liraglutide 1.8 mgn=233 | Liraglutide 0.9 mgn=233 |
|---|---|---|
| Week 0: Baseline | 93.68(11.75) | 93.82(11.50) |
| Week 26: Change from baseline | -0.44(3.04) | -0.73(3.03) |
| Week 52: Change from baseline | -1.07(3.64) | not reported |
| Measure | Liraglutide 1.8 mgn=233 | Liraglutide 0.9 mgn=233 |
|---|---|---|
| Week 0: Baseline | 74.67(15.24) | 75.13(16.46) |
| Week 26: Change from baseline | -0.77(2.01) | -0.95(2.19) |
| Week 52: Change from baseline | -1.05(2.26) | not reported |
| Measure | Liraglutide 1.8 mgn=233 | Liraglutide 0.9 mgn=233 |
|---|---|---|
| Week 0: Baseline | 27.34(4.80) | 27.20(4.72) |
| Week 26: Change from baseline | -0.28(0.72) | -0.33(0.78) |
| Week 52: Change from baseline | -0.39(0.82) | not reported |
This trial is conducted in Asia. The aim of the trial is to compare the efficacy and safety of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in Japanese subjects with type 2 diabetes mellitus.
Inclusion Criteria: * Male or female Japanese subjects at least 20 years of age at the time of informed consent * Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening * HbA1c 7.5-10.0% \[58 mmol/mol-86 mmol/mol\] (both inclusive) * Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved Japanese labelling Exclusion Criteria: * Treatment with insulin within 12 weeks prior to screening * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening * Screening calcitonin equal or above 50 ng/l * History of pancreatitis (acute or chronic) * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2) * Subjects presently classified as being in New York Heart Association (NYHA) Class IV * Within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack * Diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas) * Any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.