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.
2018년 7월 31일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
635
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Annaka-shi, Gunma, 일본, 379 0116
- Novo Nordisk Investigational Site
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Chitose, Hokkaido, 일본, 066-0032
- Novo Nordisk Investigational Site
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Chuo-ku Tokyo, 일본, 103-0027
- Novo Nordisk Investigational Site
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Chuo-ku,, 일본, 104 0061
- Novo Nordisk Investigational Site
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Chuo-ku, Tokyo, 일본, 103 0027
- Novo Nordisk Investigational Site
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Chuo-ku, Tokyo, 일본, 103 0002
- Novo Nordisk Investigational Site
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Fukuoka-shi, Fukuoka, 일본
- Novo Nordisk Investigational Site
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Higashiosaka-shi, Osaka, 일본
- Novo Nordisk Investigational Site
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Hokkaido, 일본, 078-8236
- Novo Nordisk Investigational Site
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Ichikawa-shi, Chiba, 일본
- Novo Nordisk Investigational Site
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Iruma-shi, Saitama, 일본, 358 0011
- Novo Nordisk Investigational Site
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Izumisano-shi, 일본, 598 0048
- Novo Nordisk Investigational Site
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Kashiwara-shi, Osaka, 일본, 582 0005
- Novo Nordisk Investigational Site
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Kawagoe-shi, Saitama, 일본, 350 0851
- Novo Nordisk Investigational Site
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Kobe-shi, Hyogo, 일본
- Novo Nordisk Investigational Site
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Kumamoto-shi,Kumamoto, 일본, 862 0976
- Novo Nordisk Investigational Site
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Mito-shi, Ibaraki, 일본, 310-0845
- Novo Nordisk Investigational Site
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Mito-shi, Ibaraki, 일본
- Novo Nordisk Investigational Site
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Miyazaki-shi, 일본, 880 0034
- Novo Nordisk Investigational Site
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Naka-shi, Ibaraki, 일본, 311 0113
- Novo Nordisk Investigational Site
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Neyagawa-shi, Osaka, 일본
- Novo Nordisk Investigational Site
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Nishinomiya-shi, Hygo, 일본, 662 0971
- Novo Nordisk Investigational Site
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Nishinomiya-shi, Hyogo, 일본, 663-8501
- Novo Nordisk Investigational Site
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Oita-shi, 일본, 870 0039
- Novo Nordisk Investigational Site
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Okawa-shi, Fukuoka, 일본, 831 0016
- Novo Nordisk Investigational Site
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Osaka-shi, Osaka, 일본, 553 0003
- Novo Nordisk Investigational Site
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Osaka-shi, Osaka, 일본, 5590012
- Novo Nordisk Investigational Site
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Oyama-shi, Tochigi, 일본, 323 0022
- Novo Nordisk Investigational Site
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Saga-shi,Saga, 일본, 849 0937
- Novo Nordisk Investigational Site
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Sapporo-shi, Hokkaido, 일본, 060 0062
- Novo Nordisk Investigational Site
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Sapporo-shi, Hokkaido, 일본, 060-0001
- Novo Nordisk Investigational Site
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Sapporo-shi, Hokkaido, 일본, 062 0007
- Novo Nordisk Investigational Site
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Sappro-shi, Hokkaido, 일본, 060 8648
- Novo Nordisk Investigational Site
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Shimotsuke-shi, Tochigi, 일본, 329 0433
- Novo Nordisk Investigational Site
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Shinjuku-ku, Tokyo, 일본, 160-0008
- Novo Nordisk Investigational Site
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Shizuoka-shi, 일본, 424 0853
- Novo Nordisk Investigational Site
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Suita-shi, Osaka, 일본, 565-0853
- Novo Nordisk Investigational Site
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Takatsuki-shi, Osaka, 일본, 569 1096
- Novo Nordisk Investigational Site
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Tokyo, 일본, 181-0013
- Novo Nordisk Investigational Site
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Tokyo, 일본, 103-0028
- Novo Nordisk Investigational Site
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Tokyo, 일본, 169-0073
- Novo Nordisk Investigational Site
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Tokyo, 일본, 105-8471
- Novo Nordisk Investigational Site
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Tokyo, 일본, 123-0845
- Novo Nordisk Investigational Site
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Tokyo, 일본, 144-0051
- Novo Nordisk Investigational Site
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Yokohama, Kanagawa, 일본, 236-0004
- Novo Nordisk Investigational Site
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Yokohama-shi, 일본, 235 0045
- Novo Nordisk Investigational Site
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Yokohama-shi Kanagawa, 일본, 232-0064
- Novo Nordisk Investigational Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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Injected subcutaneously s.c.
(under the skin) once daily.
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활성 비교기: 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.
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Injected subcutaneously s.c.
(under the skin) once daily.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Glycosylated Haemoglobin (HbA1c) (Week 26)
기간: Week 0, Week 26
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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.
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Week 0, Week 26
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in HbA1c (Week 52)
기간: Week 0, Week 52
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Change from baseline (week 0) in HbA1c was evaluated after 52 weeks of treatment.
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Week 0, Week 52
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Responder for HbA1c Below 7.0% (53 mmol/Mol)
기간: Week 26 and Week 52
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Reported results are number of subjects who achieved HbA1c target below 7.0% after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)
기간: Week 26 and Week 52
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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.
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Week 26 and Week 52
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Responder for HbA1c Below 7.0% Without Weight Gain
기간: Week 26 and Week 52
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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.
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Week 26 and Week 52
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Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
기간: Week 26 and Week 52
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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'
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Week 26 and Week 52
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Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
기간: Week 0 and Week 26 and Week 52
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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:
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Week 0 and Week 26 and Week 52
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Change in SMBG 7-point Profile: Mean of 7-point Profile
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in mean of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)
기간: Week 0, Week 26, Week 52
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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.
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Week 0, Week 26, Week 52
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Change in Fasting Plasma Glucose (FPG)
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in FPG was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Waist Circumference
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in waist circumference was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Body Weight
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in body weight was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Body Mass Index (BMI)
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in BMI was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Blood Pressure (Systolic and Diastolic)
기간: Week 0, Week 26, Week 52
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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.
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Week 0, Week 26, Week 52
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Fasting C-peptide
기간: Week 26 and Week 52
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Fasting C-peptide was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Fasting Insulin
기간: Week 26 and Week 52
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Fasting insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Fasting Glucagon
기간: Week 26 and Week 52
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Fasting glucagon was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Proinsulin
기간: Week 26 and Week 52
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Proinsulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Proinsulin/Insulin
기간: Week 26 and Week 52
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Proinsulin/insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
기간: Week 26 and Week 52
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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)].
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Week 26 and Week 52
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Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
기간: Week 26 and Week 52
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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.
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Week 26 and Week 52
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Total Cholesterol
기간: Week 26 and Week 52
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Total cholesterol was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Low Density Lipoprotein (LDL) Cholesterol
기간: Week 26 and Week 52
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LDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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High Density Lipoprotein (HDL) Cholesterol
기간: Week 26 and Week 52
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HDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Very Low Density Lipoprotein (VLDL) Cholesterol
기간: Week 26 and Week 52
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VLDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Triglycerides
기간: Week 26 and Week 52
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Triglycerides were evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Free Fatty Acids
기간: Week 26 and Week 52
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Free fatty acids were evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Number of Treatment Emergent Adverse Events
기간: Weeks 0-26 and Weeks 0-52
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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'.
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Weeks 0-26 and Weeks 0-52
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Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
기간: Weeks 0-26 and Weeks 0-52
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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'.
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Weeks 0-26 and Weeks 0-52
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Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
기간: Weeks 0-26 and Weeks 0-52
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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'.
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Weeks 0-26 and Weeks 0-52
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Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
기간: Weeks 0-26 and Weeks 0-52
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American Diabetes Association (ADA) classification of hypoglycaemia:
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Weeks 0-26 and Weeks 0-52
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Change in Pulse
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in pulse was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Physical Examination
기간: Week 0 and Week 26 and Week 52
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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).
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Week 0 and Week 26 and Week 52
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Change in Eye Examination
기간: Week 0 and Week 26 and Week 52
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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.
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Week 0 and Week 26 and Week 52
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Change in Electrocardiogram (ECG)
기간: Week 0 and Week 26 and Week 52
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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.
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Week 0 and Week 26 and Week 52
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Change in Biochemistry: Creatinine
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in creatinine was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: eGFR
기간: Week 0, Week 26, Week 52
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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.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Alanine Aminotransferase
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in alanine aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Aspartate Aminotransferase
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in aspartate aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Alkaline Phosphatase
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in alkaline phosphatase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Sodium
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in sodium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Potassium
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in potassium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Albumin
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in albumin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Total Bilirubin
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Urea
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in urea was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Creatine Kinase
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in creatine kinase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Calcium
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Albumin Corrected Calcium
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in albumin corrected calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Amylase
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in amylase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Lipase
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in lipase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Haematology: Haemoglobin
기간: Week 0, Week 26, Week 52
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Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Haematology: Haematocrit
기간: Week 0, Week 26, Week 52
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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.
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Week 0, Week 26, Week 52
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Change in Haematology: Thrombocytes
기간: Week 0, Week 26 and Week 52
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Change from baseline (week 0) in thrombocytes (platelets) was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26 and Week 52
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Change in Haematology: Erythrocytes
기간: Week 0, Week 26 and Week 52
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Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26 and Week 52
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Change in Haematology: Leukocytes
기간: Week 0, Week 26 and Week 52
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Change from baseline (week 0) in leukocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26 and Week 52
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Change in Haematology: Eosinophils
기간: Week 0, Week 26 and Week 52
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Change from baseline (week 0) in eosinophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26 and Week 52
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Change in Haematology: Neutrophils
기간: Week 0, Week 26 and Week 52
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Change from baseline (week 0) in neutrophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26 and Week 52
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Change in Haematology: Basophils
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2015년 7월 21일
기본 완료 (실제)
2017년 5월 2일
연구 완료 (실제)
2017년 11월 9일
연구 등록 날짜
최초 제출
2015년 7월 21일
QC 기준을 충족하는 최초 제출
2015년 7월 21일
처음 게시됨 (추정)
2015년 7월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 9월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 7월 31일
마지막으로 확인됨
2018년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NN2211-4174
- U1111-1164-5462 (기타 식별자: WHO)
- JapicCTI-152975 (레지스트리 식별자: JAPIC)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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