DiabetesPhase 3NCT02505334
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.
A Phase 3 study testing liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 47 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 635 participants
- Where
- 47 sitesJapan
- Study dates
- 21 Jul 2015to 9 Nov 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
47 sites in 1 country.
47 sites in 1 country
Japan47 sites
Novo Nordisk Investigational Site
Annaka-shi, Gunma, 379 0116
Novo Nordisk Investigational Site
Chitose, Hokkaido, 066-0032
Novo Nordisk Investigational Site
Chuo-ku Tokyo, 103-0027
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, 103 0002
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, 103 0027
Novo Nordisk Investigational Site
Chūōku, 104 0061
Novo Nordisk Investigational Site
Fukuoka-shi, Fukuoka
Novo Nordisk Investigational Site
Higashiosaka-shi, Osaka
Novo Nordisk Investigational Site
Hokkaido, 078-8236
Novo Nordisk Investigational Site
Ichikawa-shi, Chiba
Novo Nordisk Investigational Site
Iruma-shi, Saitama, 358 0011
Novo Nordisk Investigational Site
Izumisano, 598 0048
Novo Nordisk Investigational Site
Kashiwara-shi, Osaka, 582 0005
Novo Nordisk Investigational Site
Kawagoe-shi, Saitama, 350 0851
Novo Nordisk Investigational Site
Kobe-shi, Hyogo
Novo Nordisk Investigational Site
Kumamoto-shi,Kumamoto, 862 0976
Novo Nordisk Investigational Site
Mito-shi, Ibaraki, 310-0845
Novo Nordisk Investigational Site
Mito-shi, Ibaraki
Novo Nordisk Investigational Site
Miyazaki, 880 0034
Novo Nordisk Investigational Site
Naka-shi, Ibaraki, 311 0113
Novo Nordisk Investigational Site
Neyagawa-shi, Osaka
Novo Nordisk Investigational Site
Nishinomiya-shi, Hygo, 662 0971
Novo Nordisk Investigational Site
Nishinomiya-shi, Hyogo, 663-8501
Novo Nordisk Investigational Site
Ōita, 870 0039
Novo Nordisk Investigational Site
Okawa-shi, Fukuoka, 831 0016
Novo Nordisk Investigational Site
Osaka-shi, Osaka, 553 0003
Novo Nordisk Investigational Site
Osaka-shi, Osaka, 5590012
Novo Nordisk Investigational Site
Oyama-shi, Tochigi, 323 0022
Novo Nordisk Investigational Site
Saga-shi,Saga, 849 0937
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, 060 0062
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, 060-0001
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, 062 0007
Novo Nordisk Investigational Site
Sappro-shi, Hokkaido, 060 8648
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, 329 0433
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, 160-0008
Novo Nordisk Investigational Site
Shizuoka, 424 0853
Novo Nordisk Investigational Site
Suita-shi, Osaka, 565-0853
Novo Nordisk Investigational Site
Takatsuki-shi, Osaka, 569 1096
Novo Nordisk Investigational Site
Tokyo, 103-0028
Novo Nordisk Investigational Site
Tokyo, 105-8471
Novo Nordisk Investigational Site
Tokyo, 123-0845
Novo Nordisk Investigational Site
Tokyo, 144-0051
Novo Nordisk Investigational Site
Tokyo, 169-0073
Novo Nordisk Investigational Site
Tokyo, 181-0013
Novo Nordisk Investigational Site
Yokohama, 235 0045
Novo Nordisk Investigational Site
Yokohama-shi Kanagawa, 232-0064
Novo Nordisk Investigational Site
Yokohama, Kanagawa, 236-0004
About this study
Official title: 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
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.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- liraglutide
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Injected subcutaneously s.c. (under the skin) once daily.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide 1.8 mg | Experimental | 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. Receives: Drug: liraglutide |
| Liraglutide 0.9 mg | Active comparator | 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. Receives: Drug: liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycosylated Haemoglobin (HbA1c) (Week 26)
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of treatment. The change from baseline in the response after 26 weeks of treatment is analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline response as a covariate.
Measured: Week 0, Week 26
Secondary outcomes (60)
Change in HbA1c (Week 52)
Change from baseline (week 0) in HbA1c was evaluated after 52 weeks of treatment.
Measured: Week 0, Week 52
Responder for HbA1c Below 7.0% (53 mmol/Mol)
Reported results are number of subjects who achieved HbA1c target below 7.0% after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 26 and Week 52
Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Reported results are number of subjects who achieved HbA1c target below or equal to 6.5% after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 26 and Week 52
Responder for HbA1c Below 7.0% Without Weight Gain
Reported results are number of subjects who achieved HbA1c target below 7.0% without weight gain after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 26 and Week 52
Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Reported results are subjects with HbA1c <7.0% after 26 weeks and 52 weeks of treatment, respectively without treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. Severe or BG confirmed symptomatic hypoglycaemia: severe as per ADA classification or BG confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA: episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent: episode with onset date on or after randomisation (from week (wk)0) and no later than 7 days after the last day on liraglutide (maximum till wk26+7days and wk52+7days). Hence, the following shown 'Time Frame' should be read as 'Wk26+7days and Wk52+7days'
Measured: Week 26 and Week 52
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Reported results are 7-point SMBG values at week 0, week 26 and week 52. The 7-point profile blood glucose levels were measured at the following time points always starting with the first:
- Before breakfast.
- 90 minutes after start of breakfast.
- Before lunch.
- 90 minutes after start of lunch.
- Before dinner.
- 90 minutes after start of dinner.
- At bedtime.
Measured: Week 0 and Week 26 and Week 52
Change in SMBG 7-point Profile: Mean of 7-point Profile
Change from baseline (week 0) in mean of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)
Change from baseline (week 0) in mean of postprandial increments (from before meal to 90 minutes after for breakfast, lunch and dinner) of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) in FPG was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Waist Circumference
Change from baseline (week 0) in waist circumference was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Body Weight
Change from baseline (week 0) in body weight was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Body Mass Index (BMI)
Change from baseline (week 0) in BMI was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Blood Pressure (Systolic and Diastolic)
Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Fasting C-peptide
Fasting C-peptide was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 26 and Week 52
Fasting Insulin
Fasting insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 26 and Week 52
Fasting Glucagon
Fasting glucagon was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 26 and Week 52
Proinsulin
Proinsulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 26 and Week 52
Proinsulin/Insulin
Proinsulin/insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 26 and Week 52
Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
HOMA-B was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B=[(20 x fasting insulin in µU/mL)/(FPG in mmol/L-3.5)].
Measured: Week 26 and Week 52
Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
HOMA-IR was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-IR is an index of insulin resistance and was calculated as: HOMA-IR= fasting insulin (μU/mL) x FPG (mmol/L)/22.5.
Measured: Week 26 and Week 52
Total Cholesterol
Total cholesterol was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 26 and Week 52
Low Density Lipoprotein (LDL) Cholesterol
LDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 26 and Week 52
High Density Lipoprotein (HDL) Cholesterol
HDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 26 and Week 52
Very Low Density Lipoprotein (VLDL) Cholesterol
VLDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 26 and Week 52
Triglycerides
Triglycerides were evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 26 and Week 52
Free Fatty Acids
Free fatty acids were evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 26 and Week 52
Number of Treatment Emergent Adverse Events
Treatment emergent adverse events (TEAEs) were evaluated during the 26-week and 52-week treatment period, respectively. TEAE for weeks 0-26: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 + 7 days). TEAE for weeks 0-52: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 52 + 7 days). Hence, the following shown 'Time Frame' should be read as 'Weeks 0-26 + 7 days and Weeks 0-52 + 7 days'.
Measured: Weeks 0-26 and Weeks 0-52
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the 26-week and 52-week treatment period, respectively. Severe or BG confirmed symptomatic hypoglycaemia (hypo):An episode that was severe according to the ADA classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypo. ADA definition of severe hypo:episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent: episode with onset date on or after randomisation (from week (wk) 0) and no later than 7 days after the last day on liraglutide (maximum till wk 26 and wk 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'wk 0-26+7 days and wk 0-52+7 days'.
Measured: Weeks 0-26 and Weeks 0-52
Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Treatment emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the26-week and 52-week treatment period, respectively. Nocturnal hypoglycaemic episodes: Those occurring between 00:01 and 05:59 hours, both inclusive. Severe or BG confirmed symptomatic hypoglycaemia: episode that was severe according to the ADA classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Treatment emergent: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'Week 0-26 + 7 days and Week 0-52 + 7 days'.
Measured: Weeks 0-26 and Weeks 0-52
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
American Diabetes Association (ADA) classification of hypoglycaemia:
- Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.
- Documented symptomatic: PG level ≤3.9 mmol/L with symptoms.
- Asymptomatic: PG level ≤3.9 mmol/L without symptoms.
- Probable symptomatic: No measurement with symptoms.
- Pseudo: PG level >3.9 mmol/L with symptoms. Treatment emergent hypoglycaemic episode: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'Week 0-26 + 7 days and Week 0-52 + 7 days'.
Measured: Weeks 0-26 and Weeks 0-52
Change in Pulse
Change from baseline (week 0) in pulse was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Physical Examination
Reported results are physical examination outcomes at week (wk) 0, wk 26 and wk 52. Physical examination consisted of the following listed examinations and the outcome of each examination was evaluated as: 1) normal, 2) abnormal, not clinically significant (NCS) or 3) abnormal, clinically significant (CS).
- Cardiovascular system
- Central and peripheral nervous system (PNS)
- Gastrointestinal (GI) system including mouth
- General appearance
- Head, ears, eyes, nose, throat, neck
- Lymph node palpation
- Musculoskeletal system
- Respiratory system
- Skin
- Thyroid gland
Measured: Week 0 and Week 26 and Week 52
Change in Eye Examination
Reported results are eye examination (ophthalmoscopy) outcomes at week 0, week 26 and week 52. Ophthalmoscopy outcomes for both left and right eye were evaluated as: 1) normal, 2) abnormal, NCS or 3) abnormal, CS.
Measured: Week 0 and Week 26 and Week 52
Change in Electrocardiogram (ECG)
Reported results are ECG outcomes at week 0, week 26 and week 52. ECG outcomes were evaluated as: 1) normal, 2) abnormal, NCS or 3) abnormal, CS.
Measured: Week 0 and Week 26 and Week 52
Change in Biochemistry: Creatinine
Change from baseline (week 0) in creatinine was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Biochemistry: eGFR
Change from baseline (week 0) in estimated glomerular filtration rate (eGFR) was evaluated after 26 weeks and 52 weeks of treatment, respectively. eGFR was evaluated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, mL/min/1.73m^2.
Measured: Week 0, Week 26, Week 52
Change in Biochemistry: Alanine Aminotransferase
Change from baseline (week 0) in alanine aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Biochemistry: Aspartate Aminotransferase
Change from baseline (week 0) in aspartate aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Biochemistry: Alkaline Phosphatase
Change from baseline (week 0) in alkaline phosphatase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Biochemistry: Sodium
Change from baseline (week 0) in sodium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Biochemistry: Potassium
Change from baseline (week 0) in potassium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Biochemistry: Albumin
Change from baseline (week 0) in albumin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Biochemistry: Total Bilirubin
Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Biochemistry: Urea
Change from baseline (week 0) in urea was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Biochemistry: Creatine Kinase
Change from baseline (week 0) in creatine kinase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Biochemistry: Calcium
Change from baseline (week 0) in calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Biochemistry: Albumin Corrected Calcium
Change from baseline (week 0) in albumin corrected calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Biochemistry: Amylase
Change from baseline (week 0) in amylase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Biochemistry: Lipase
Change from baseline (week 0) in lipase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Haematology: Haemoglobin
Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26, Week 52
Change in Haematology: Haematocrit
Change from baseline (week 0) in haematocrit was evaluated after 26 weeks and 52 weeks of treatment, respectively. Haematocrit is the ratio of the volume of red blood cells to the total volume of blood.
Measured: Week 0, Week 26, Week 52
Change in Haematology: Thrombocytes
Change from baseline (week 0) in thrombocytes (platelets) was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26 and Week 52
Change in Haematology: Erythrocytes
Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26 and Week 52
Change in Haematology: Leukocytes
Change from baseline (week 0) in leukocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26 and Week 52
Change in Haematology: Eosinophils
Change from baseline (week 0) in eosinophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26 and Week 52
Change in Haematology: Neutrophils
Change from baseline (week 0) in neutrophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26 and Week 52
Change in Haematology: Basophils
Change from baseline (week 0) in basophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26 and Week 52
Change in Haematology: Monocytes
Change from baseline (week 0) in monocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26 and Week 52
Change in Haematology: Lymphocytes
Change from baseline (week 0) in lymphocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Measured: Week 0, Week 26 and Week 52
Change in Calcitonin
Reported results are number of subjects with low, normal or high calcitonin values at week 0, week 26 and week 52. Number of subjects analyzed = number of subjects contributed to the analysis for individual time point. Calcitonin values were categorised as low, normal or high.
Measured: Week 0 and Week 26 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study start21 Jul 2015
- Primary completion2 May 2017
- Study completion9 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 635 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure 1452, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505334
- Sponsor's protocol ID
- NN2211-4174
- Other IDs
- U1111-1164-5462, JapicCTI-152975
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2015
- Last updated
- 5 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02505334
- Acronym / sponsor ID
- NN2211-4174
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 635 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2015 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 9 Nov 2017 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Posted 25 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide 1.8 mg | Experimental | Drug: liraglutideThe 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 | Active comparator | Drug: liraglutideThe 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 may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutideInjected subcutaneously s.c. (under the skin) once daily. | Drug | Liraglutide 0.9 mg, Liraglutide 1.8 mg |
Primary outcome
Change in Glycosylated Haemoglobin (HbA1c) (Week 26)
Time frame: Week 0, Week 26
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of treatment. The change from baseline in the response after 26 weeks of treatment is analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline response as a covariate.
60 secondary outcomes
Change in HbA1c (Week 52)
Time frame: Week 0, Week 52
Responder for HbA1c Below 7.0% (53 mmol/Mol)
Time frame: Week 26 and Week 52
Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Time frame: Week 26 and Week 52
Responder for HbA1c Below 7.0% Without Weight Gain
Time frame: Week 26 and Week 52
Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: Week 26 and Week 52
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Time frame: Week 0 and Week 26 and Week 52
Change in SMBG 7-point Profile: Mean of 7-point Profile
Time frame: Week 0, Week 26, Week 52
Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)
Time frame: Week 0, Week 26, Week 52
Change in Fasting Plasma Glucose (FPG)
Time frame: Week 0, Week 26, Week 52
Change in Waist Circumference
Time frame: Week 0, Week 26, Week 52
Change in Body Weight
Time frame: Week 0, Week 26, Week 52
Change in Body Mass Index (BMI)
Time frame: Week 0, Week 26, Week 52
Change in Blood Pressure (Systolic and Diastolic)
Time frame: Week 0, Week 26, Week 52
Fasting C-peptide
Time frame: Week 26 and Week 52
Fasting Insulin
Time frame: Week 26 and Week 52
Fasting Glucagon
Time frame: Week 26 and Week 52
Proinsulin
Time frame: Week 26 and Week 52
Proinsulin/Insulin
Time frame: Week 26 and Week 52
Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
Time frame: Week 26 and Week 52
Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
Time frame: Week 26 and Week 52
Total Cholesterol
Time frame: Week 26 and Week 52
Low Density Lipoprotein (LDL) Cholesterol
Time frame: Week 26 and Week 52
High Density Lipoprotein (HDL) Cholesterol
Time frame: Week 26 and Week 52
Very Low Density Lipoprotein (VLDL) Cholesterol
Time frame: Week 26 and Week 52
Triglycerides
Time frame: Week 26 and Week 52
Free Fatty Acids
Time frame: Week 26 and Week 52
Number of Treatment Emergent Adverse Events
Time frame: Weeks 0-26 and Weeks 0-52
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: Weeks 0-26 and Weeks 0-52
Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: Weeks 0-26 and Weeks 0-52
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
Time frame: Weeks 0-26 and Weeks 0-52
Change in Pulse
Time frame: Week 0, Week 26, Week 52
Change in Physical Examination
Time frame: Week 0 and Week 26 and Week 52
Change in Eye Examination
Time frame: Week 0 and Week 26 and Week 52
Change in Electrocardiogram (ECG)
Time frame: Week 0 and Week 26 and Week 52
Change in Biochemistry: Creatinine
Time frame: Week 0, Week 26, Week 52
Change in Biochemistry: eGFR
Time frame: Week 0, Week 26, Week 52
Change in Biochemistry: Alanine Aminotransferase
Time frame: Week 0, Week 26, Week 52
Change in Biochemistry: Aspartate Aminotransferase
Time frame: Week 0, Week 26, Week 52
Change in Biochemistry: Alkaline Phosphatase
Time frame: Week 0, Week 26, Week 52
Change in Biochemistry: Sodium
Time frame: Week 0, Week 26, Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure 1452 study director
Novo Nordisk A/S
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing liraglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 47 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycosylated Haemoglobin (HbA1c) (Week 26) (time frame: Week 0, Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.