Phase 3 · Liraglutide

NCT02505334 trial results

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.

Participants
635
Status
completed
Completed
2017-11-09
Sponsor
Novo Nordisk A/S

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.

Primary outcome

What NCT02505334 measured first

Change in Glycosylated Haemoglobin (HbA1c) (Week 26)Percentage (%) of HbA1c · Week 0, Week 26 · least squares mean
Liraglutide 1.8 mgn=233Liraglutide 0.9 mgn=233
-0.23(0.06)0.17(0.06)
Side effects by arm

Side effects in NCT02505334

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.

EventLiraglutide 1.8 mgLiraglutide 0.9 mg
Any serious event3.4%1.3%
Viral upper respiratory tract infection28.3%18.9%
Diabetic retinopathy9.9%7.3%
Constipation7.3%2.1%
Lipase increased5.6%2.6%
Secondary outcomes

What else it measured

Change in HbA1c (Week 52)Percentage (%) of HbA1c · Week 0, Week 52 · mean
MeasureLiraglutide 1.8 mgn=233
Week 0: Baseline8.14(1.02)
Week 52: Change from baseline-0.09(1.05)
Responder for HbA1c Below 7.0% (53 mmol/Mol)Participants · Week 26 and Week 52 · count of participants
MeasureLiraglutide 1.8 mgn=233Liraglutide 0.9 mgn=233
Week 265318
Week 5245not reported
Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)Participants · Week 26 and Week 52 · count of participants
MeasureLiraglutide 1.8 mgn=233Liraglutide 0.9 mgn=233
Week 26185
Week 5216not reported
Responder for HbA1c Below 7.0% Without Weight GainParticipants · Week 26 and Week 52 · count of participants
MeasureLiraglutide 1.8 mgn=233Liraglutide 0.9 mgn=233
Week 263613
Week 5235not reported
Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic EpisodesParticipants · Week 26 and Week 52 · count of participants
MeasureLiraglutide 1.8 mgn=233Liraglutide 0.9 mgn=233
Week 265318
Week 5245not reported
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)mg/dL · Week 0 and Week 26 and Week 52 · mean
MeasureLiraglutide 1.8 mgn=233Liraglutide 0.9 mgn=233
Week 0: Before breakfast181.8(42.8)177.1(43.4)
Week 0: 90 minutes after start of breakfast262.6(65.0)266.5(70.0)
Week 0: Before lunch169.5(57.7)177.6(61.7)
Week 0: 90 minutes after start of lunch253.1(64.5)252.2(63.5)
Week 0: Before dinner173.4(59.2)169.7(56.5)
Week 0: 90 minutes after start of dinner254.3(66.2)249.5(63.2)
Week 0: At bedtime226.1(67.4)217.8(58.7)
Week 26: Before breakfast171.7(39.6)178.2(44.4)
Week 26: 90 minutes after start of breakfast247.2(64.6)258.2(63.7)
Week 26: Before lunch161.2(51.0)177.0(57.9)
Week 26: 90 minutes after start of lunch234.7(63.3)255.3(66.7)
Week 26: Before dinner162.3(47.5)168.6(57.5)
Change in SMBG 7-point Profile: Mean of 7-point Profilemg/dL · Week 0, Week 26, Week 52 · mean
MeasureLiraglutide 1.8 mgn=233Liraglutide 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
Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)mg/dL · Week 0, Week 26, Week 52 · mean
MeasureLiraglutide 1.8 mgn=233Liraglutide 0.9 mgn=233
Week 0: Baseline81.7(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
Change in Fasting Plasma Glucose (FPG)mg/dL · Week 0, Week 26, Week 52 · mean
MeasureLiraglutide 1.8 mgn=233Liraglutide 0.9 mgn=233
Week 0: Baseline172.5(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
Change in Waist CircumferenceCentimeter (cm) · Week 0, Week 26, Week 52 · mean
MeasureLiraglutide 1.8 mgn=233Liraglutide 0.9 mgn=233
Week 0: Baseline93.68(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
Change in Body WeightKilogram (kg) · Week 0, Week 26, Week 52 · mean
MeasureLiraglutide 1.8 mgn=233Liraglutide 0.9 mgn=233
Week 0: Baseline74.67(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
Change in Body Mass Index (BMI)kg/m^2 · Week 0, Week 26, Week 52 · mean
MeasureLiraglutide 1.8 mgn=233Liraglutide 0.9 mgn=233
Week 0: Baseline27.34(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
The trial

How NCT02505334 was run

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.

  • Liraglutide 1.8 mg: The total trial duration for the 1.8 mg/day treatment arm will be approximately 67 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week main treatment period, a safety extension period of 26 weeks and a follow-up visit.
  • Liraglutide 0.9 mg: The total trial duration for the 0.9 mg/day treatment arm will be approximately 41 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week treatment period, and a follow-up visit.
Who could join the trial

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.

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