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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. července 2018 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Lék: liraglutide

Typ studie

Intervenční

Zápis (Aktuální)

635

Fáze

Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

20 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Léčba
Přidělení: Randomizované
Intervenční model: Paralelní přiřazení
Maskování: Žádné (otevřený štítek)

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm	Intervence / Léčba
Experimentální: 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.	Lék: liraglutide Injected subcutaneously s.c. (under the skin) once daily.
Aktivní komparátor: 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.	Lék: liraglutide Injected subcutaneously s.c. (under the skin) once daily.

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Change in Glycosylated Haemoglobin (HbA1c) (Week 26) Časové okno: 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

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Change in HbA1c (Week 52) Časové okno: 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) Časové okno: 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) Časové okno: 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 Časové okno: 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 Časové okno: 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) Časové okno: 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 Časové okno: 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) Časové okno: 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) Časové okno: 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 Časové okno: 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 Časové okno: 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) Časové okno: 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) Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: Week 26 and Week 52	Fasting glucagon was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 26 and Week 52
Proinsulin Časové okno: Week 26 and Week 52	Proinsulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 26 and Week 52
Proinsulin/Insulin Časové okno: 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) Časové okno: 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) Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: Week 26 and Week 52	VLDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.	Week 26 and Week 52
Triglycerides Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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) Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Novo Nordisk A/S

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Clinical Trials at Novo Nordisk

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

21. července 2015

Primární dokončení (Aktuální)

2. května 2017

Dokončení studie (Aktuální)

9. listopadu 2017

Termíny zápisu do studia

První předloženo

21. července 2015

První předloženo, které splnilo kritéria kontroly kvality

21. července 2015

První zveřejněno (Odhad)

22. července 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. září 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

31. července 2018

Naposledy ověřeno

1. července 2018

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

NN2211-4174
U1111-1164-5462 (Jiný identifikátor: WHO)
JapicCTI-152975 (Identifikátor registru: JAPIC)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

produkt vyrobený a vyvážený z USA

Ano

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Diabetes mellitus, typ 2

Korea United Pharm. Inc.

Zatím nenabíráme

Studie k vyhodnocení bezpečnosti a farmakokinetiky přípravku UI087 ve srovnání s podáváním UIC202506, UIC202507 a UIC202508 u zdravých dospělých dobrovolníků v podmínkách nalačno

Diabetes mellitus (typ 2)

Jižní Korea
Helen Keller Eye Research Foundation
Five Lakes Clinical Research Consulting, LLC

Nábor

Prevence oddělení sítnice (profylaxe) u Sticklerova syndromu (SS) (OSC/SS)

Sticklerův syndrom typu 2 | Sticklerův syndrom typu 1

Spojené státy
Izmir Bakircay University

Dokončeno

Užívání inzulinu a síla dýchacích svalů u diabetes mellitus 2. typu

Diabetes mellitus, typ 2 | Diabetes Mellitus, typ 2 léčený inzulínem

Turecko (Türkiye)
Griffin Hospital
California Walnut Commission

Dokončeno

Účinky konzumace vlašských ořechů na endoteliální funkci u diabetu 2. typu (WALNUT)

DIABETES MELLITUS TYP 2

Spojené státy
Services Hospital, Lahore

Dokončeno

Srovnání hypoglykemických režimů během ramadánu u diabetu 2. typu

Diabetes, typ 2

Pákistán
Zhejiang Provincial People's Hospital
Shandong Suncadia Medicine Co., Ltd.

Nábor

Účinnost a bezpečnost henagliflozinového prolinu a metforminu hydrochloridu prodloužený uvolňující tablety (ⅰ) versus metforminové tablety u pacientů s diabetem nového nástupu typu 2: multicentrická, randomizovaná kontrolovaná studie

Diabetes nového nástupu na typ 2

Čína
Universite du Quebec en Outaouais
University Hospital, Angers; McGill University; Centre de Recherche du Centre...

Zatím nenabíráme

Mapování diabetu v Quebecu: validace medicínsko-administrativních algoritmů pro diabetes 1. typu, diabetes 2. typu a LADA (VDA)

Diabetes mellitus, typ 1 | Diabetes, autoimunita | Diabetes typu 2 | Diabetes; Nástup v dospělosti

Kanada
Embecta Corp.
Jaeb Center for Health Research

Staženo

Systém Embecta AID u dospělých s diabetem 2 (EMBRACE-T2D)

Cukrovka typu 2 | Diabetes mellitus 2. typu (T2DM) | T2DM (diabetes mellitus 2. typu) | T2D | T2DM | Typ 2 DM | T2DM s nedostatečnou kontrolou glykémie

Spojené státy
Fujifilm Medical Systems USA, Inc.
International HealthCare, LLC

Zatím nenabíráme

Akvizice a klinické vyhodnocení snímků vysokého rozlišení (HR) digitální mamografické tomosyntézy (DBT) společnosti Fujifilm.

Rutinní screeningová mamografie
University of Roma La Sapienza

Neznámý

Vliv alopurinolu na mono a současné podávání se statiny na krevní destičky Reaktivita u diabetických pacientů léčených aspirinem a inzulínem

Diabetes Mellitus Typ 2 Reaktivita krevních destiček Statin

Itálie

Klinické studie na liraglutide

Woman's
Novo Nordisk A/S

Dokončeno

Liraglutid 3 mg (Saxenda) na váhu, stavbu těla, hormonální a metabolické parametry u obézních žen s PCOS (SAXAPCOS)

Syndrom polycystických vaječníků | Prediabetes | Obezita Android

Spojené státy
Novo Nordisk A/S

Dokončeno

Metabolismus a vylučování liraglutidu u zdravých mužských dobrovolníků

Zdravý | Diabetes

Holandsko
Henrik Gudbergsen
Novo Nordisk A/S; Cambridge Weight Plan Limited

Dokončeno

Liraglutid 3 mg pro osteoartrózu kolene (LOSEIT)

Obezita | Osteoartróza

Dánsko
Henrik Gudbergsen

Dokončeno

Ultrazvuk kolena u obézních pacientů s osteoartrózou kolena; Údržba hmotnosti (US-LOSEIT-II)

Obezita | Osteoartróza

Dánsko
Henrik Gudbergsen

Dokončeno

Multiparametrické zobrazení kolena u obézních pacientů s osteoartrózou kolena; Údržba hmotnosti (IM-LOSEIT-II)

Obezita | Osteoartróza

Dánsko
Parker Research Institute

Dokončeno

Změny autoflouresence kůže po hubnutí a údržbě pomocí liraglutidu u osteoartrózy kolena

Osteoartróza, koleno

Dánsko
Merck Sharp & Dohme LLC

Dokončeno

Hodnocení glukoregulačních účinků aktivace receptoru glukagonu podobného peptidu-1 (GLP-1 receptor) u účastníků s diabetes mellitus 2. typu (MK-0000-222)

Diabetes mellitus 2. typu
Henrik Gudbergsen

Dokončeno

Biomarkery u obézních pacientů s osteoartrózou kolene; Údržba hmotnosti (BIO-LOSEIT-II)

Obezita | Osteoartróza

Dánsko
University Medical Centre Ljubljana

Dokončeno

Nízká dávka liraglutidu a metforminu vs. vysoká dávka liraglutidu samotného v léčbě obezity

Obezita | Syndrom polycystických vaječníků

Slovinsko
Stanford University

Dokončeno

Účinek liraglutidu (Victoza) na zánět v lidské tukové tkáni a krvi

Zánět | Diabetes mellitus, typ 2 | Diabetes Mellitus, typ II | Diabetes Mellitus, nástup v dospělosti

Spojené státy

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.