A Study in Participants With Type 1 Diabetes Mellitus (IMAGINE 1)
2018년 3월 16일 업데이트: Eli Lilly and Company
The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: An Open-Label, Randomized, 78-Week Study - The IMAGINE 1 Study
The purpose of this study is:
- To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of treatment.
- To compare the rate of night-time low blood sugar episodes on LY2605541 with insulin glargine during 78 weeks of treatment.
- To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 78 weeks of treatment.
- To compare the rate of hypoglycemia episodes on LY2605541 with insulin glargine during 78 weeks of treatment.
연구 개요
연구 유형
중재적
등록 (실제)
455
단계
- 3단계
연락처 및 위치
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연구 장소
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Berlin, 독일, 10409
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Eisenach, 독일, 99817
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Falkensee, 독일, 14612
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Hamburg, 독일, 22559
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Mainz, 독일, 55116
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Mayen, 독일, 56727
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Münster, 독일, 48153
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Neuwied, 독일, 56564
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Pohlheim, 독일, 35415
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Arkhangelsk, 러시아 연방, 163045
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Moscow, 러시아 연방, 119991
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Saint Petersburg, 러시아 연방, 193257
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Guadalajara, 멕시코, 44150
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Guadalajara Jalisco, 멕시코, 04460
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Monterrey, 멕시코, 64460
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California
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Concord, California, 미국, 94520
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Escondido, California, 미국, 92026
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Fresno, California, 미국, 93720
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Greenbrae, California, 미국, 94904
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Huntington Beach, California, 미국, 92648
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San Mateo, California, 미국, 94401
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Colorado
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Aurora, Colorado, 미국, 80010
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Idaho
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Idaho Falls, Idaho, 미국, 83404
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Nevada
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Las Vegas, Nevada, 미국, 89148
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Utah
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Salt Lake City, Utah, 미국, 84102
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Washington
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Renton, Washington, 미국, 98057
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Spokane, Washington, 미국, 99202
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Graz, 오스트리아, 8036
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Vienna, 오스트리아, 1130
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Cagliari, 이탈리아, 09100
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Catania, 이탈리아, 95100
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Lecce, 이탈리아, 73100
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Padova, 이탈리아, 35128
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Perugia, 이탈리아, 06100
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Ravenna, 이탈리아, 48100
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Hokkaido, 일본, 060-0002
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Kanagawa, 일본, 235-0045
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Kumamoto, 일본, 862-0976
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Tokyo, 일본, 162-8666
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Katowice, 폴란드, 40-057
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Lodz, 폴란드, 93-338
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Poznan, 폴란드, 61-655
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Warsaw, 폴란드, 01-192
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Bar Le Duc, 프랑스, 55000
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Corbeil-Essonnes, 프랑스, 91100
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Montpellier, 프랑스, 34295
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Nantes, 프랑스, 44093
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Nice, 프랑스, 06002
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Saint Mande, 프랑스, 94160
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Toulouse, 프랑스, 31059
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Venissieux, 프랑스, 69200
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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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Have had diabetes mellitus for at least 1 year
- Have an hemoglobin A1c (HbA1c) value less than 12% according to the central laboratory at screening
- Have a body mass index (BMI) less than or equal to 35.0 kilograms per square meter (kg/m^2)
Have been treated for at least 90 days prior to screening with the following:
- Insulin detemir, insulin glargine, or human insulin isophane suspension (NPH) insulin in combination with premeal insulin,
- Self-mixed or premixed insulin regimens with any basal and bolus insulin combination administered at least twice daily, or
- Continuous SC insulin infusion therapy
This inclusion criterion applies to female participants:
- Are not breastfeeding
- Test negative for pregnancy at screening and randomization based on serum pregnancy tests
- Do not intend to become pregnant during the study
- Have practiced a reliable method of birth control (for example, use of oral contraceptives or levonorgestrel, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, intrauterine devices, partner with vasectomy, or abstinence) for at least 6 weeks prior to screening
- Agree to continue to use a reliable method of birth control during the study, as determined by the investigator (and for 2 weeks following the last dose of study drug)
- Capable of and willing and desirous to do the following: adhere to a multiple daily injection regimen, inject insulin with a prefilled pen and perform Self-Monitored Blood Glucose (SMBG) and record keeping as required by this protocol, as determined by the investigator. Caregiver may be responsible for all of the above.
Exclusion Criteria:
- Are using twice-daily insulin glargine having been inadequately controlled on once-daily dosed glargine prior to screening
- Have excessive insulin resistance defined as having received a total daily dose of insulin greater than 1.5 units per kilogram (units/kg) at the time of randomization
- Receiving any oral or injectable medication (other than metformin for treatment of polycystic ovarian disease) intended for the treatment of diabetes mellitus other than insulins in the 90 days prior to screening
Lipid-lowering medications:
- Are using niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or are using lipid-lowering medication at a dose that has not been stable for greater than or equal to 90 days prior to screening
- If a participant has not been on a stable dose of lipid-lowering medication for greater than or equal to 90 days prior to screening, the site should wait to screen the participant. If the results of the screening laboratory tests require a change to the participant's current lipid-lowering medication or initiation of lipid-lowering medication, it is acceptable to change the lipid-lowering medication for the participant and to have the participant return greater than or equal to 90 days later to complete some of the screening procedures again
- Have fasting hypertriglyceridemia (defined as greater than 4.5 millimoles per liter [mmol/L], greater than 400 milligrams per deciliter [mg/dL]) at screening, as determined by the central laboratory
- Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia as determined by the investigator) within 6 months prior to entry into the study
- Have had 2 or more emergency room visits or hospitalizations due to poor glucose control (hyperglycemia or diabetic ketoacidosis) in the past 6 months
- Cardiovascular: have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association Cardiac Disease Classification)
- Renal: Have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine greater than 2.5 mg/dL
Hepatic: Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements as indicated below:
- Total bilirubin greater than or equal to 2 times the upper limit of normal (ULN) as defined by the central laboratory,
- Alanine aminotransferase (ALT)/(serum glutamic pyruvic transaminase (SGPT) greater than 2.5 times ULN as defined by the central laboratory, or
- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) greater than 2.5 times ULN as defined by the central laboratory.
- Malignancy: Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at an increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
- Allergy: Have known hypersensitivity or allergy to any of the study insulins or their excipients
- Hematologic: Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c measurement
- Glucocorticoid therapy: Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical , intraocular, intranasal, and inhaled preparations) or have received such therapy within 8 weeks immediately before screening with the exception of replacement therapy for adrenal insufficiency
- Diagnosed clinically significant diabetic autonomic neuropathy, in the opinion of the investigator
- Have any other condition (including known drug or alcohol abuse or psychiatric disorder including eating disorder) that precludes the participant from following and completing 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 |
|---|---|
|
실험적: LY2605541 + Insulin Lispro
LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro.
Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
|
Administered by SC injection with a pen device.
Administered by SC injection with a pen device.
다른 이름들:
|
|
활성 비교기: Glargine + Insulin Lispro
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro.
Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
|
Administered by SC injection with a pen device.
다른 이름들:
Administered by SC injection via a pen device.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Hemoglobin A1c (HbA1c) at 26 Weeks
기간: 26 weeks
|
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe.
Least Squares (LS) means were calculated using mixed model repeated measures (MMRM), adjusting for treatment, stratification factors (baseline low-density lipoprotein cholesterol [LDL-C] [<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.
|
26 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Hemoglobin A1c (HbA1c)
기간: 52 weeks and 78 weeks
|
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe.
LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C [<100 mg/dL and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.
|
52 weeks and 78 weeks
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Change From Baseline in Hemoglobin A1c (HbA1c)
기간: Baseline, 26 weeks, 52 weeks, 78 weeks
|
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe.
LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C [<100 mg/dL and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.
|
Baseline, 26 weeks, 52 weeks, 78 weeks
|
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Percentage of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% or Less Than or Equal to 6.5% Using Last Observation Carried Forward (LOCF)
기간: 26 weeks and 52 weeks and 78 weeks
|
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe.
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, then multiplying by 100.
|
26 weeks and 52 weeks and 78 weeks
|
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Proportion of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% Without Nocturnal Hypoglycemia
기간: 26 weeks and 52 weeks and 78 weeks
|
Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 millimoles per liter [mmol/L]).
A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM.
The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, then multiplying by 100.
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26 weeks and 52 weeks and 78 weeks
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Total Hypoglycemia Rates (Adjusted by 30 Days)
기간: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
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Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L).
Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log [exposure in days/30] as an offset variable).
Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
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Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
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Percentage of Participants With Total Hypoglycemia Events
기간: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
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Hypoglycemic events are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L).
The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, then multiplying by 100.
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Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
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Nocturnal Hypoglycemia Rates (Adjusted by 30 Days)
기간: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
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Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L).
A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM.
Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log [exposure in days/30] as an offset variable).
Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
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Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
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Percentage of Participants With Nocturnal Hypoglycemic Events
기간: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
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Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L).
A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM.
The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, then multiplying by 100.
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Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
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Fasting Serum Glucose (FSG) by Laboratory Measurement
기간: 26 weeks and 52 weeks and 78 weeks
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LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.
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26 weeks and 52 weeks and 78 weeks
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Fasting Blood Glucose (FBG) Intra-participant Variability
기간: 26 weeks and 52 weeks and 78 weeks
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FBG was measured by self-monitored blood glucose (SMBG).
Between-day glucose variability is measured by the standard deviation of FBG.
LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.
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26 weeks and 52 weeks and 78 weeks
|
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0300-hour Blood Glucose (BG) to Fasting Blood (FBG) Glucose Excursion
기간: 26 weeks and 52 weeks and 78 weeks
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Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only SMBG profiles with both 0300 hours and the next day pre-morning measurements are included for the calculation of such excursion).
LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
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26 weeks and 52 weeks and 78 weeks
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9 Point Self-monitored Blood Glucose (SMBG)
기간: 26 weeks and 52 weeks and 78 weeks
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9-point SMBG profiles were obtained over 2 days within the week prior to Weeks 0, 4, 12, 26, 39, 52, 65, and 78.
SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the pre-morning meal the next day.
LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
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26 weeks and 52 weeks and 78 weeks
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Change From Baseline in Body Weight
기간: Baseline and 26 weeks and 52 weeks and 78 weeks
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LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.
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Baseline and 26 weeks and 52 weeks and 78 weeks
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Basal, Bolus, and Total Insulin Dose
기간: 26 weeks and 52 weeks and 78 weeks
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Basal insulin dose, short-acting bolus insulin dose (each meal and overall), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit.
LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
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26 weeks and 52 weeks and 78 weeks
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Lipid Profile
기간: 26 weeks and 52 weeks and 78 weeks
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Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized.
LS means were calculated using MMRM, adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL] except for the LDL-C outcome variable), visit, treatment, treatment-by-visit interaction, and baseline value of corresponding lipid outcome variable.
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26 weeks and 52 weeks and 78 weeks
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Percentage of Participants With Change in Anti-LY2605541 Antibodies
기간: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
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The percentage of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized.
TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable or from detectable to the value with at least 130% relative increase from baseline.
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Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
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Insulin Treatment Satisfaction Questionnaire (ITSQ)
기간: 26 weeks
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ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin.
The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device.
Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction.
LS means were calculated using an analysis of covariance (ANCOVA) model with treatment and stratification (baseline HbA1c [≤8.5% or >8.5%] and country) as fixed effects and baseline value of the dependent variable as a covariate.
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26 weeks
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Low Blood Sugar Survey (LBSS)
기간: 26 weeks and 52 weeks and 78 weeks
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LBSS (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items).
Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always.
Total score is the sum of all items (range 0-132).
Higher total scores reflect greater fear of hypoglycemia.
LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%] and country), visit, treatment-by-visit interaction , and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
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26 weeks and 52 weeks and 78 weeks
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European Quality of Life-5 Dimension (EQ-5D)
기간: 26 weeks
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The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument.
The profile allows participants to rate their health state in 5 health domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) using a 3-level scale of 1-3 (no problem, some problems, and extreme problems).
These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm.
Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health.
LS means were calculated using ANCOVA, adjusting for treatment and stratification factors (baseline HbA1c [≤8.5% or >8.5%] and country) as fixed effects and baseline EQ-5D score as a covariate.
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26 weeks
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Rapid Assessment of Physical Activity (RAPA)
기간: 26 weeks and 78 weeks
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The RAPA questionnaire assesses the level and intensity of physical activity of adult participants.
It contains 2 subscales: RAPA 1 (Aerobic) and RAPA 2 (Strength and Flexibility).
RAPA 1 contains 7 questions regarding the participant's amount and intensity of physical activity, allowing each participant's aerobic activity level to be categorized as sedentary, underactive, light activities, light activity, regular underactive, or active.
RAPA 2 contains 2 questions regarding participants' physical activities that increase strength and improve flexibility.
Each participant's strength and flexibility activity level is then categorized as neither strength nor flexibility (flex) activity, either strength or flex (not both), both strength and flex activity.
The percentage of participants in each RAPA 1/2 category is presented and was calculated by dividing the number of participants in each RAPA 1/2 category by the total number of participants analyzed, then multiplying by 100.
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26 weeks and 78 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Sanyal A, Cusi K, Hartman ML, Zhang S, Bastyr EJ 3rd, Bue-Valleskey JM, Chang AM, Haupt A, Jacober SJ, Konrad RJ, Zhang Q, Hoogwerf BJ. Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins. J Investig Med. 2018 Mar;66(3):661-668. doi: 10.1136/jim-2017-000609. Epub 2017 Nov 21.
- Orchard TJ, Cariou B, Connelly MA, Otvos JD, Zhang S, Antalis CJ, Ivanyi T, Hoogwerf BJ. The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes. Cardiovasc Diabetol. 2017 Jun 6;16(1):73. doi: 10.1186/s12933-017-0555-1.
- Cusi K, Sanyal AJ, Zhang S, Hartman ML, Bue-Valleskey JM, Hoogwerf BJ, Haupt A. Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1630-1634. doi: 10.1111/dom.12973. Epub 2017 Jun 22.
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
2012년 1월 1일
기본 완료 (실제)
2013년 5월 1일
연구 완료 (실제)
2014년 6월 1일
연구 등록 날짜
최초 제출
2011년 11월 28일
QC 기준을 충족하는 최초 제출
2011년 11월 28일
처음 게시됨 (추정)
2011년 11월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 4월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 3월 16일
마지막으로 확인됨
2018년 3월 1일
추가 정보
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. .
제1형 당뇨병에 대한 임상 시험
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Rhythm Pharmaceuticals, Inc.완전한Pro-opiomelanocortin(POMC), Proprotein Convertase Subtilisin/Kexin Type 1(PCSK1) 및 Leptin 수용체(LepR) 유전자 돌연변이미국, 이스라엘, 캐나다, 독일, 그리스, 이탈리아, 포르투갈
LY2605541에 대한 임상 시험
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Eli Lilly and Company완전한
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Eli Lilly and Company완전한
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Eli Lilly and Company완전한제1형 당뇨병영국, 미국, 호주, 캐나다, 폴란드, 덴마크, 스페인, 크로아티아, 스웨덴, 그리스, 벨기에, 프랑스, 뉴질랜드, 남아프리카, 이스라엘, 브라질, 아일랜드, 네덜란드, 리투아니아, 슬로바키아
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Eli Lilly and Company완전한제2형 당뇨병미국, 브라질, 독일, 이스라엘, 이탈리아, 영국, 호주, 헝가리, 푸에르토 리코, 루마니아, 러시아 연방, 스페인, 폴란드, 캐나다, 그리스, 칠면조, 멕시코, 뉴질랜드, 남아프리카, 아르헨티나, 핀란드, 리투아니아, 슬로바키아