Phase 3
Completed N=466
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.
Source: ClinicalTrials.gov NCT02505334 ↗Enrolled (actual)
466
Serious AEs
2.4%
Results posted
Jun 2018
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) (Week 26) — -0.23; 0.17 Percentage (%) of HbA1c — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) (Week 26) |
-0.23; 0.17 | <0.0001 sig |
| SECONDARY Change in HbA1c (Week 52) |
8.14; -0.09 | — |
| SECONDARY Responder for HbA1c Below 7.0% (53 mmol/Mol) |
53; 18; 45 | — |
| SECONDARY Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol) |
18; 5; 16 | — |
| SECONDARY Responder for HbA1c Below 7.0% Without Weight Gain |
36; 13; 35 | — |
| SECONDARY Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes |
53; 18; 45 | — |
| SECONDARY Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile) |
181.8; 177.1; 262.6; 266.5; 169.5; 177.6 | — |
| SECONDARY Change in SMBG 7-point Profile: Mean of 7-point Profile |
217.9; 217.7; -14.5; -0.6; -8.9 | — |
| SECONDARY Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner) |
81.7; 81.6; -8.4; -1.5; -6.3 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
172.5; 172.0; -8.4; 1.0; -1.2 | — |
| SECONDARY Change in Waist Circumference |
93.68; 93.82; -0.44; -0.73; -1.07 | — |
| SECONDARY Change in Body Weight |
74.67; 75.13; -0.77; -0.95; -1.05 | — |
| SECONDARY Change in Body Mass Index (BMI) |
27.34; 27.20; -0.28; -0.33; -0.39 | — |
| SECONDARY Change in Blood Pressure (Systolic and Diastolic) |
128.0; 128.8; -1.7; 0.4; -0.9; 79.6 | — |
| SECONDARY Fasting C-peptide |
1.946; 1.853; 1.906 | — |
| SECONDARY Fasting Insulin |
77.00; 70.91; 77.31 | — |
| SECONDARY Fasting Glucagon |
22.5; 23.4; 23.4 | — |
| SECONDARY Proinsulin |
15.638; 16.054; 16.217 | — |
| SECONDARY Proinsulin/Insulin |
20.31; 22.64; 20.98 | — |
| SECONDARY Homeostasis Model Assessment of Beta-cell Function (HOMA-B) |
42.06; 35.54; 40.03 | — |
| SECONDARY Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR) |
4.388; 4.262; 4.567 | — |
| SECONDARY Total Cholesterol |
191.2; 194.5; 190.6 | — |
| SECONDARY Low Density Lipoprotein (LDL) Cholesterol |
103.4; 107.1; 104.5 | — |
| SECONDARY High Density Lipoprotein (HDL) Cholesterol |
52.7; 52.9; 53.3 | — |
| SECONDARY Very Low Density Lipoprotein (VLDL) Cholesterol |
26.8; 27.8; 25.9 | — |
| SECONDARY Triglycerides |
135.4; 142.3; 130.4 | — |
| SECONDARY Free Fatty Acids |
12.56; 12.99; 12.19 | — |
| SECONDARY Number of Treatment Emergent Adverse Events |
365; 266; 588 | — |
| SECONDARY Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes |
0; 0; 0 | — |
| SECONDARY Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes |
0; 0; 0 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition |
0; 0; 0; 0; 2; 1 | — |
| SECONDARY Change in Pulse |
80.2; 80.8; 0.8; 0.2; 0.2 | — |
| SECONDARY Change in Physical Examination |
229; 230; 3; 0; 1; 3 | — |
| SECONDARY Change in Eye Examination |
183; 176; 15; 13; 35; 44 | — |
| SECONDARY Change in Electrocardiogram (ECG) |
202; 196; 31; 35; 0; 2 | — |
| SECONDARY Change in Biochemistry: Creatinine |
0.802; 0.822; 0.018; 0.011; 0.025 | — |
| SECONDARY Change in Biochemistry: eGFR |
78.6; 77.6; -1.5; -1.0; -2.3 | — |
| SECONDARY Change in Biochemistry: Alanine Aminotransferase |
32.7; 34.2; -0.4; -2.2; -2.4 | — |
| SECONDARY Change in Biochemistry: Aspartate Aminotransferase |
26.5; 26.9; 0.2; -1.0; -1.2 | — |
| SECONDARY Change in Biochemistry: Alkaline Phosphatase |
72.5; 74.1; 0.6; 2.0; 2.1 | — |
| SECONDARY Change in Biochemistry: Sodium |
140.2; 140.2; 0.1; 0.2; 0.3 | — |
| SECONDARY Change in Biochemistry: Potassium |
4.40; 4.38; -0.01; -0.02; 0.00 | — |
| SECONDARY Change in Biochemistry: Albumin |
44.7; 45.1; -0.2; -0.2; -0.2 | — |
| SECONDARY Change in Biochemistry: Total Bilirubin |
0.52; 0.53; 0.04; 0.04; 0.06 | — |
| SECONDARY Change in Biochemistry: Urea |
13.5; 14.0; 0.3; -0.0; 0.7 | — |
| SECONDARY Change in Biochemistry: Creatine Kinase |
117.3; 129.3; 5.2; -5.2; 7.5 | — |
| SECONDARY Change in Biochemistry: Calcium |
9.66; 9.66; -0.01; 0.01; 0.01 | — |
| SECONDARY Change in Biochemistry: Albumin Corrected Calcium |
9.28; 9.26; 0.00; 0.02; 0.02 | — |
| SECONDARY Change in Biochemistry: Amylase |
62.3; 61.1; -0.9; -2.3; -0.7 | — |
| SECONDARY Change in Biochemistry: Lipase |
55.4; 57.3; -1.4; -3.3; -1.0 | — |
| SECONDARY Change in Haematology: Haemoglobin |
14.65; 14.56; -0.00; 0.04; -0.00 | — |
| SECONDARY Change in Haematology: Haematocrit |
44.86; 44.65; -0.22; -0.06; -0.49 | — |
| SECONDARY Change in Haematology: Thrombocytes |
229.1; 231.0; 0.8; -1.5; 3.4 | — |
| SECONDARY Change in Haematology: Erythrocytes |
4.87; 4.89; -0.02; -0.00; -0.04 | — |
| SECONDARY Change in Haematology: Leukocytes |
6.55; 6.53; 0.09; -0.08; 0.09 | — |
| SECONDARY Change in Haematology: Eosinophils |
0.182; 0.167; 0.001; -0.016; -0.008 | — |
| SECONDARY Change in Haematology: Neutrophils |
3.967; 3.975; 0.054; -0.088; 0.062 | — |
| SECONDARY Change in Haematology: Basophils |
0.024; 0.026; 0.004; 0.000; 0.000 | — |
| SECONDARY Change in Haematology: Monocytes |
0.341; 0.326; 0.001; -0.000; 0.019 | — |
| SECONDARY Change in Haematology: Lymphocytes |
2.034; 2.037; 0.032; 0.022; 0.014 | — |
| SECONDARY Change in Calcitonin |
0; 0; 229; 229; 4; 3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02505334). 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.