A Study for Patients With Type 2 Diabetes
2018년 5월 4일 업데이트: Eli Lilly and Company
A Phase 2 Study of LY2605541 Compared With Insulin Glargine in the Treatment of Type 2 Diabetes Mellitus
Comparison of fasting blood glucose levels in patients with Type 2 diabetes after 12 weeks of treatment with a new basal insulin analog or with insulin glargine.
연구 개요
상세 설명
Patients in this study will continue to use their stable prestudy dose of metformin and/or a sulfonylurea.
Prestudy therapy also includes once daily insulin glargine or neutral protamine Hagedorn (NPH) insulin.
The 12-week active treatment phase will be followed by a 4-week follow-up period, during which patients will return to the basal insulin recommended by the investigator.
연구 유형
중재적
등록 (실제)
289
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Arkhangelsk, 러시아 연방, 163045
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Moscow, 러시아 연방, 119881
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Rostov-On-Don, 러시아 연방, 344022
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Saint Petersburg, 러시아 연방, 193257
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Cluj-Napoca, 루마니아, 400006
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Iasi, 루마니아, 70057
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Targu Mures, 루마니아, 540098
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Idaho
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Idaho Falls, Idaho, 미국, 83404
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Minnesota
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Minneapolis, Minnesota, 미국, 55416
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Texas
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Dallas, Texas, 미국, 75230
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Alicante, 스페인, 03114
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Dos Hermanas, 스페인, 41014
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Malaga, 스페인, 29010
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Bialystok, 폴란드, 15-950
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Lublin, 폴란드, 20-044
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Hato Rey, 푸에르토 리코, 00917
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Manati, 푸에르토 리코, 00674
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San Juan, 푸에르토 리코, 00907
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Budapest, 헝가리, H-1139
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Gyula, 헝가리, 5700
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Veszprem, 헝가리, 8200
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New South Wales
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Coffs Harbour, New South Wales, 호주, 2450
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South Australia
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Keswick, South Australia, 호주, 5035
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Victoria
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Ringwood East, Victoria, 호주, 3135
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Western Australia
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Fremantle, Western Australia, 호주, 6160
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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:
- Type 2 diabetes mellitus (T2DM) for at least 1 year
- At least 18 years of age
- Using metformin and/or sulfonylurea(s) with once daily glargine or NPH for at least 3 months prior to the study. Prestudy dose requirements: insulin dose maximum 1.0 unit/kilogram/day (U/kg/day). Oral antihyperglycemic medications (OAMs): Metformin dose at least 1500 milligram/day (mg/day) and/or sulfonylurea dose at least half the maximum daily dose specified in the local package insert. OAM doses stable for 6 weeks prior to the study.
- Hemoglobin A1c (HbA1c) less than or equal to 10.5% before randomization
- Body Mass Index (BMI) 19 to 45 kilogram/square meter (kg/m²)
- Capable and willing to prepare and inject insulin with a syringe while continuing to use the prestudy OAMs, monitor own blood glucose; complete the study diary; be receptive to diabetes education; comply with study visits and receive telephone calls between visits
- Women of childbearing potential must test negative for pregnancy before receiving treatment and agree to use reliable birth control until completing the follow-up visit
Exclusion Criteria:
- Long-term use of short- or rapid-acting or premixed insulin within the 6 months before the study. Short-term insulin therapy or occasional use are permitted
- Use of any glucose-lowering medications not allowed by the inclusion criteria in the 3 months before entry into the study
- Use of prescription or over-the-counter medications to promote weight loss within 3 months before entry into the study
- Current participation in a weight loss program, or plans to do so during the study
- Treatment with any antibody-based therapy within 6 months prior to the study
- Use of chronic (>14 consecutive days) systemic glucocorticoid therapy currently or within 4 weeks prior to the study
- More than 1 episode of severe hypoglycemia within 6 months prior to the study, or currently diagnosed with hypoglycemia unawareness
- 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months preceding the study
- Liver disease
- History of renal transplantation, current renal dialysis, or creatinine >2.0 milligram/deciliter (mg/dL) (177 micromole/Liter [μmol]/L)
- Cardiac disease with a marked impact on physical functioning
- Clinically significant electrocardiogram (ECG) abnormalities at screening
- Malignancy other than basal cell or squamous cell skin cancer
- Fasting triglycerides >500 mg/dL
- Known diabetic autonomic neuropathy
- Known hypersensitivity or allergy to study insulin or its excipients
- Blood transfusion or severe blood loss within 3 months prior to entry into the study or known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c methodology
- Irregular sleep/wake cycle
- Women who are breastfeeding
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: LY2605541 Dosing Algorithm 1
Participants took both LY2605541 and their pre-study insulin for first several days
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subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
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실험적: LY2605541 Dosing Algorithm 2
Participants took only LY2605541 with first dose doubled
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subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
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활성 비교기: 인슐린 글라진
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subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Fasting Blood Glucose (FBG) Level at Week 12 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles
기간: Week 12
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8-point SMBG profiles are measured at morning FBG, midday and evening pre-meal blood glucose (BG), 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG.
Least squares (LS) mean of the FBG is from mixed-model repeated measures (MMRM) approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-interim analysis [IA], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline hemoglobin A1c [HbA1c] group); visit; visit and treatment interaction; random effect for participant.
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Week 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint
기간: Baseline, Week 12
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FBG is measured by 8-point SMBG profiles, which are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG.
LS mean of the change from baseline to 12 weeks is from MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and random effect for participant.
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Baseline, Week 12
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Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 Endpoint
기간: Baseline, Week 12
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HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
LS mean of the change from baseline is from MMRM approach.
MMRM model includes fixed effects of treatment (LY2605541 dose algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group); baseline HbA1c; visit; visit and treatment interaction; and a random effect for participant.
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Baseline, Week 12
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Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint
기간: Week 12
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HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
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Week 12
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Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment
기간: Week 12
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HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 millimole/Liter (mmol/L) (≤70 milligram/deciliter [mg/dL]) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).
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Week 12
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8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint
기간: Week 12
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8-point SMBG profiles are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG.
LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.
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Week 12
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Daily Basal Insulin Dose at Week 2 and Week 12
기간: Week 2 and Week 12
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LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.
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Week 2 and Week 12
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Percentage of Participants With Hypoglycemia From Baseline Through Week 12
기간: Baseline through Week 12
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Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).
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Baseline through Week 12
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Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12
기간: Baseline through Week 12
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Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).
Hypoglycemia rate per 30 days is calculated as the number of hypoglycemia/number of days at risk*30.
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Baseline through Week 12
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Percentage of Participants With Antibody Status Change From Baseline to Week 12 and Week 16
기간: Week 12 and Week 16
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Negative is defined as either 'negative' from lab or percent binding <1.16%.
Positive is defined as the percent binding is ≥1.16%.
The antibody status change is from negative to positive or positive to negative.
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Week 12 and Week 16
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Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12
기간: Baseline and Week12
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Within-patient glycemic variability was assessed as the standard deviation of fasting blood glucose each day at baseline, and each day between Week 10 and Week 12. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.
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Baseline and Week12
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Pharmacokinetics - Drug (LY2605541) Concentration at Steady State (Css) at Week 12 Endpoint
기간: Week 12
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The drug (LY2605541) concentration at steady state (Css) is calculated from the clearance (Liter/hour) and the final dose of the participants.
Clearance was estimated using population-based approaches.
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Week 12
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Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
기간: Baseline, Week 12
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FBG is measured by 8-point SMBG profiles, which are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG.
LS mean of the change from baseline to 12 weeks is from MMRM approach.
MMRM model includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.
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Baseline, Week 12
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Change From Baseline in HbA1c at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
기간: Baseline, Week 12
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HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
LS mean of the change from baseline is from MMRM approach.
MMRM model includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group); baseline HbA1c; visit; visit and treatment interaction; and a random effect for participant.
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Baseline, Week 12
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Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
기간: Week 12
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HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
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Week 12
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Percentage of Participants Who Did Not Experience a Hypoglycemic Episode During Treatment With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
기간: Week 12
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HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).
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Week 12
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8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
기간: Week 12
|
8-point SMBG profiles are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG.
LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.
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Week 12
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Daily Basal Insulin Dose at Week 2 and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms
기간: Week 2 and Week 12
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LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.
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Week 2 and Week 12
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Percentage of Participants With Hypoglycemia From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms
기간: Baseline through Week 12
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Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).
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Baseline through Week 12
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Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms
기간: Baseline through Week 12
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Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).
Hypoglycemia rate per 30 days is calculated as the number of hypoglycemia/number of days at risk*30.
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Baseline through Week 12
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Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms
기간: Baseline and Week 12
|
Within-patient glycemic variability was assessed as the standard deviation of fasting blood glucose each day at baseline, and each day between Week 10 and Week 12. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant.
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Baseline and Week 12
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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
- Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available.
- Bergenstal RM, Rosenstock J, Bastyr EJ 3rd, Prince MJ, Qu Y, Jacober SJ. Lower glucose variability and hypoglycemia measured by continuous glucose monitoring with novel long-acting insulin LY2605541 versus insulin glargine. Diabetes Care. 2014;37(3):659-65. doi: 10.2337/dc12-2621. Epub 2013 Nov 6.
- Bergenstal RM, Rosenstock J, Arakaki RF, Prince MJ, Qu Y, Sinha VP, Howey DC, Jacober SJ. A randomized, controlled study of once-daily LY2605541, a novel long-acting basal insulin, versus insulin glargine in basal insulin-treated patients with type 2 diabetes. Diabetes Care. 2012 Nov;35(11):2140-7. doi: 10.2337/dc12-0060. Epub 2012 Oct 9.
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
2010년 1월 1일
기본 완료 (실제)
2010년 12월 1일
연구 완료 (실제)
2011년 1월 1일
연구 등록 날짜
최초 제출
2009년 12월 8일
QC 기준을 충족하는 최초 제출
2009년 12월 8일
처음 게시됨 (추정)
2009년 12월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 6월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 5월 4일
마지막으로 확인됨
2018년 5월 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. .
제2형 당뇨병에 대한 임상 시험
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Postgraduate Institute of Medical Education and...완전한
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