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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. juli 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

635

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: liraglutide
Injected subcutaneously s.c. (under the skin) once daily.
Aktiv komparator: 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.
Medicin: liraglutide
Injected subcutaneously s.c. (under the skin) once daily.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Glycosylated Haemoglobin (HbA1c) (Week 26)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in HbA1c (Week 52)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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:

  1. Before breakfast.
  2. 90 minutes after start of breakfast.
  3. Before lunch.
  4. 90 minutes after start of lunch.
  5. Before dinner.
  6. 90 minutes after start of dinner.
  7. At bedtime.
Week 0 and Week 26 and Week 52
Change in SMBG 7-point Profile: Mean of 7-point Profile
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 26 and Week 52
Fasting glucagon was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Week 26 and Week 52
Proinsulin
Tidsramme: Week 26 and Week 52
Proinsulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Week 26 and Week 52
Proinsulin/Insulin
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 26 and Week 52
VLDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Week 26 and Week 52
Triglycerides
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Weeks 0-26 and Weeks 0-52

American Diabetes Association (ADA) classification of hypoglycaemia:

  1. 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.
  2. Documented symptomatic: PG level ≤3.9 mmol/L with symptoms.
  3. Asymptomatic: PG level ≤3.9 mmol/L without symptoms.
  4. Probable symptomatic: No measurement with symptoms.
  5. 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
Tidsramme: 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
Tidsramme: 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).

  1. Cardiovascular system
  2. Central and peripheral nervous system (PNS)
  3. Gastrointestinal (GI) system including mouth
  4. General appearance
  5. Head, ears, eyes, nose, throat, neck
  6. Lymph node palpation
  7. Musculoskeletal system
  8. Respiratory system
  9. Skin
  10. Thyroid gland
Week 0 and Week 26 and Week 52
Change in Eye Examination
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novo Nordisk A/S

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. juli 2015

Primær færdiggørelse (Faktiske)

2. maj 2017

Studieafslutning (Faktiske)

9. november 2017

Datoer for studieregistrering

Først indsendt

21. juli 2015

Først indsendt, der opfyldte QC-kriterier

21. juli 2015

Først opslået (Skøn)

22. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. juli 2018

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN2211-4174
  • U1111-1164-5462 (Anden identifikator: WHO)
  • JapicCTI-152975 (Registry Identifier: JAPIC)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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