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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.

31 luglio 2018 aggiornato da: Novo Nordisk A/S

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Droga: liraglutide

Tipo di studio

Interventistico

Iscrizione (Effettivo)

635

Fase

Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Giappone
- - Annaka-shi, Gunma, Giappone, 379 0116
    - Novo Nordisk Investigational Site
  - Chitose, Hokkaido, Giappone, 066-0032
    - Novo Nordisk Investigational Site
  - Chuo-ku Tokyo, Giappone, 103-0027
    - Novo Nordisk Investigational Site
  - Chuo-ku,, Giappone, 104 0061
    - Novo Nordisk Investigational Site
  - Chuo-ku, Tokyo, Giappone, 103 0027
    - Novo Nordisk Investigational Site
  - Chuo-ku, Tokyo, Giappone, 103 0002
    - Novo Nordisk Investigational Site
  - Fukuoka-shi, Fukuoka, Giappone
    - Novo Nordisk Investigational Site
  - Higashiosaka-shi, Osaka, Giappone
    - Novo Nordisk Investigational Site
  - Hokkaido, Giappone, 078-8236
    - Novo Nordisk Investigational Site
  - Ichikawa-shi, Chiba, Giappone
    - Novo Nordisk Investigational Site
  - Iruma-shi, Saitama, Giappone, 358 0011
    - Novo Nordisk Investigational Site
  - Izumisano-shi, Giappone, 598 0048
    - Novo Nordisk Investigational Site
  - Kashiwara-shi, Osaka, Giappone, 582 0005
    - Novo Nordisk Investigational Site
  - Kawagoe-shi, Saitama, Giappone, 350 0851
    - Novo Nordisk Investigational Site
  - Kobe-shi, Hyogo, Giappone
    - Novo Nordisk Investigational Site
  - Kumamoto-shi,Kumamoto, Giappone, 862 0976
    - Novo Nordisk Investigational Site
  - Mito-shi, Ibaraki, Giappone, 310-0845
    - Novo Nordisk Investigational Site
  - Mito-shi, Ibaraki, Giappone
    - Novo Nordisk Investigational Site
  - Miyazaki-shi, Giappone, 880 0034
    - Novo Nordisk Investigational Site
  - Naka-shi, Ibaraki, Giappone, 311 0113
    - Novo Nordisk Investigational Site
  - Neyagawa-shi, Osaka, Giappone
    - Novo Nordisk Investigational Site
  - Nishinomiya-shi, Hygo, Giappone, 662 0971
    - Novo Nordisk Investigational Site
  - Nishinomiya-shi, Hyogo, Giappone, 663-8501
    - Novo Nordisk Investigational Site
  - Oita-shi, Giappone, 870 0039
    - Novo Nordisk Investigational Site
  - Okawa-shi, Fukuoka, Giappone, 831 0016
    - Novo Nordisk Investigational Site
  - Osaka-shi, Osaka, Giappone, 553 0003
    - Novo Nordisk Investigational Site
  - Osaka-shi, Osaka, Giappone, 5590012
    - Novo Nordisk Investigational Site
  - Oyama-shi, Tochigi, Giappone, 323 0022
    - Novo Nordisk Investigational Site
  - Saga-shi,Saga, Giappone, 849 0937
    - Novo Nordisk Investigational Site
  - Sapporo-shi, Hokkaido, Giappone, 060 0062
    - Novo Nordisk Investigational Site
  - Sapporo-shi, Hokkaido, Giappone, 060-0001
    - Novo Nordisk Investigational Site
  - Sapporo-shi, Hokkaido, Giappone, 062 0007
    - Novo Nordisk Investigational Site
  - Sappro-shi, Hokkaido, Giappone, 060 8648
    - Novo Nordisk Investigational Site
  - Shimotsuke-shi, Tochigi, Giappone, 329 0433
    - Novo Nordisk Investigational Site
  - Shinjuku-ku, Tokyo, Giappone, 160-0008
    - Novo Nordisk Investigational Site
  - Shizuoka-shi, Giappone, 424 0853
    - Novo Nordisk Investigational Site
  - Suita-shi, Osaka, Giappone, 565-0853
    - Novo Nordisk Investigational Site
  - Takatsuki-shi, Osaka, Giappone, 569 1096
    - Novo Nordisk Investigational Site
  - Tokyo, Giappone, 181-0013
    - Novo Nordisk Investigational Site
  - Tokyo, Giappone, 103-0028
    - Novo Nordisk Investigational Site
  - Tokyo, Giappone, 169-0073
    - Novo Nordisk Investigational Site
  - Tokyo, Giappone, 105-8471
    - Novo Nordisk Investigational Site
  - Tokyo, Giappone, 123-0845
    - Novo Nordisk Investigational Site
  - Tokyo, Giappone, 144-0051
    - Novo Nordisk Investigational Site
  - Yokohama, Kanagawa, Giappone, 236-0004
    - Novo Nordisk Investigational Site
  - Yokohama-shi, Giappone, 235 0045
    - Novo Nordisk Investigational Site
  - Yokohama-shi Kanagawa, Giappone, 232-0064
    - Novo Nordisk Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

20 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Nessuno (etichetta aperta)

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: 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.	Droga: liraglutide Injected subcutaneously s.c. (under the skin) once daily.
Comparatore attivo: 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.	Droga: liraglutide Injected subcutaneously s.c. (under the skin) once daily.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Change in Glycosylated Haemoglobin (HbA1c) (Week 26) Lasso di tempo: 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.	Week 0, Week 26

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Change in HbA1c (Week 52) Lasso di tempo: Week 0, Week 52	Change from baseline (week 0) in HbA1c was evaluated after 52 weeks of treatment.	Week 0, Week 52
Responder for HbA1c Below 7.0% (53 mmol/Mol) Lasso di tempo: Week 26 and Week 52	Reported results are number of subjects who achieved HbA1c target below 7.0% after 26 weeks and 52 weeks of treatment, respectively.	Week 26 and Week 52
Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol) Lasso di tempo: Week 26 and Week 52	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.	Week 26 and Week 52
Responder for HbA1c Below 7.0% Without Weight Gain Lasso di tempo: Week 26 and Week 52	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.	Week 26 and Week 52
Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes Lasso di tempo: Week 26 and Week 52	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'	Week 26 and Week 52
Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile) Lasso di tempo: Week 0 and Week 26 and Week 52	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.	Week 0 and Week 26 and Week 52
Change in SMBG 7-point Profile: Mean of 7-point Profile Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in mean of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.	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) Lasso di tempo: Week 0, Week 26, Week 52	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.	Week 0, Week 26, Week 52
Change in Fasting Plasma Glucose (FPG) Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in FPG was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Waist Circumference Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in waist circumference was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Body Weight Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in body weight was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Body Mass Index (BMI) Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in BMI was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Blood Pressure (Systolic and Diastolic) Lasso di tempo: Week 0, Week 26, Week 52	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.	Week 0, Week 26, Week 52
Fasting C-peptide Lasso di tempo: Week 26 and Week 52	Fasting C-peptide was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 26 and Week 52
Fasting Insulin Lasso di tempo: Week 26 and Week 52	Fasting insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 26 and Week 52
Fasting Glucagon Lasso di tempo: Week 26 and Week 52	Fasting glucagon was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 26 and Week 52
Proinsulin Lasso di tempo: Week 26 and Week 52	Proinsulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 26 and Week 52
Proinsulin/Insulin Lasso di tempo: Week 26 and Week 52	Proinsulin/insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 26 and Week 52
Homeostasis Model Assessment of Beta-cell Function (HOMA-B) Lasso di tempo: Week 26 and Week 52	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)].	Week 26 and Week 52
Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR) Lasso di tempo: Week 26 and Week 52	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.	Week 26 and Week 52
Total Cholesterol Lasso di tempo: Week 26 and Week 52	Total cholesterol was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 26 and Week 52
Low Density Lipoprotein (LDL) Cholesterol Lasso di tempo: Week 26 and Week 52	LDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 26 and Week 52
High Density Lipoprotein (HDL) Cholesterol Lasso di tempo: Week 26 and Week 52	HDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 26 and Week 52
Very Low Density Lipoprotein (VLDL) Cholesterol Lasso di tempo: Week 26 and Week 52	VLDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 26 and Week 52
Triglycerides Lasso di tempo: Week 26 and Week 52	Triglycerides were evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 26 and Week 52
Free Fatty Acids Lasso di tempo: Week 26 and Week 52	Free fatty acids were evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 26 and Week 52
Number of Treatment Emergent Adverse Events Lasso di tempo: Weeks 0-26 and Weeks 0-52	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'.	Weeks 0-26 and Weeks 0-52
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes Lasso di tempo: Weeks 0-26 and Weeks 0-52	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'.	Weeks 0-26 and Weeks 0-52
Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes Lasso di tempo: Weeks 0-26 and Weeks 0-52	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'.	Weeks 0-26 and Weeks 0-52
Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition Lasso di tempo: Weeks 0-26 and Weeks 0-52	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'.	Weeks 0-26 and Weeks 0-52
Change in Pulse Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in pulse was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Physical Examination Lasso di tempo: Week 0 and Week 26 and Week 52	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	Week 0 and Week 26 and Week 52
Change in Eye Examination Lasso di tempo: Week 0 and Week 26 and Week 52	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.	Week 0 and Week 26 and Week 52
Change in Electrocardiogram (ECG) Lasso di tempo: Week 0 and Week 26 and Week 52	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.	Week 0 and Week 26 and Week 52
Change in Biochemistry: Creatinine Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in creatinine was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Biochemistry: eGFR Lasso di tempo: Week 0, Week 26, Week 52	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.	Week 0, Week 26, Week 52
Change in Biochemistry: Alanine Aminotransferase Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in alanine aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Biochemistry: Aspartate Aminotransferase Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in aspartate aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Biochemistry: Alkaline Phosphatase Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in alkaline phosphatase was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Biochemistry: Sodium Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in sodium was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Biochemistry: Potassium Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in potassium was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Biochemistry: Albumin Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in albumin was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Biochemistry: Total Bilirubin Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Biochemistry: Urea Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in urea was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Biochemistry: Creatine Kinase Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in creatine kinase was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Biochemistry: Calcium Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Biochemistry: Albumin Corrected Calcium Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in albumin corrected calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Biochemistry: Amylase Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in amylase was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Biochemistry: Lipase Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in lipase was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Haematology: Haemoglobin Lasso di tempo: Week 0, Week 26, Week 52	Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26, Week 52
Change in Haematology: Haematocrit Lasso di tempo: Week 0, Week 26, Week 52	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.	Week 0, Week 26, Week 52
Change in Haematology: Thrombocytes Lasso di tempo: Week 0, Week 26 and Week 52	Change from baseline (week 0) in thrombocytes (platelets) was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26 and Week 52
Change in Haematology: Erythrocytes Lasso di tempo: Week 0, Week 26 and Week 52	Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26 and Week 52
Change in Haematology: Leukocytes Lasso di tempo: Week 0, Week 26 and Week 52	Change from baseline (week 0) in leukocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26 and Week 52
Change in Haematology: Eosinophils Lasso di tempo: Week 0, Week 26 and Week 52	Change from baseline (week 0) in eosinophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26 and Week 52
Change in Haematology: Neutrophils Lasso di tempo: Week 0, Week 26 and Week 52	Change from baseline (week 0) in neutrophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26 and Week 52
Change in Haematology: Basophils Lasso di tempo: Week 0, Week 26 and Week 52	Change from baseline (week 0) in basophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26 and Week 52
Change in Haematology: Monocytes Lasso di tempo: Week 0, Week 26 and Week 52	Change from baseline (week 0) in monocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26 and Week 52
Change in Haematology: Lymphocytes Lasso di tempo: Week 0, Week 26 and Week 52	Change from baseline (week 0) in lymphocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 0, Week 26 and Week 52
Change in Calcitonin Lasso di tempo: Week 0 and Week 26 and Week 52	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.	Week 0 and Week 26 and Week 52

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novo Nordisk A/S

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Clinical Trials at Novo Nordisk

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

21 luglio 2015

Completamento primario (Effettivo)

2 maggio 2017

Completamento dello studio (Effettivo)

9 novembre 2017

Date di iscrizione allo studio

Primo inviato

21 luglio 2015

Primo inviato che soddisfa i criteri di controllo qualità

21 luglio 2015

Primo Inserito (Stima)

22 luglio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 settembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 luglio 2018

Ultimo verificato

1 luglio 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

NN2211-4174
U1111-1164-5462 (Altro identificatore: WHO)
JapicCTI-152975 (Identificatore di registro: JAPIC)

Piano per i dati dei singoli partecipanti (IPD)

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SÌ

Descrizione del piano IPD

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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.