이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin

2019년 2월 8일 업데이트: Daiichi Sankyo, Inc.

A Randomized, Double-Blind, Placebo-Controlled With Active Comparator, 12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin

The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

298

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35216
    • Arizona
      • Litchfield Park, Arizona, 미국, 85340
      • Tempe, Arizona, 미국, 85282
    • California
      • Anaheim, California, 미국, 92801
      • Chino, California, 미국, 91710
      • Chula Vista, California, 미국, 91911
      • Fresno, California, 미국, 93720
      • Gold River, California, 미국, 95670
      • Greenbrae, California, 미국, 94904
      • San Diego, California, 미국, 92103
    • Colorado
      • Colorado Springs, Colorado, 미국, 80920
      • Lakewood, Colorado, 미국, 80227
    • Florida
      • Hallandale Beach, Florida, 미국, 33009
      • Miami, Florida, 미국, 33126
      • Miami, Florida, 미국, 33135
      • Pembroke Pines, Florida, 미국, 33026
      • West Palm Beach, Florida, 미국, 33409
    • Georgia
      • Atlanta, Georgia, 미국, 30331
    • Idaho
      • Boise, Idaho, 미국, 83704
    • Indiana
      • Avon, Indiana, 미국, 46123
      • Evansville, Indiana, 미국, 47725
      • Franklin, Indiana, 미국, 46131
      • Greenfield, Indiana, 미국, 46140
    • Iowa
      • Council Bluffs, Iowa, 미국, 51503
    • Michigan
      • Troy, Michigan, 미국, 48098
    • Minnesota
      • Edina, Minnesota, 미국, 55435
    • Missouri
      • Washington, Missouri, 미국, 63090
    • Nebraska
      • Omaha, Nebraska, 미국, 68114
    • North Carolina
      • Mooresville, North Carolina, 미국, 28117
      • Morgantown, North Carolina, 미국, 28655
      • Winston-Salem, North Carolina, 미국, 27103
    • Ohio
      • Columbus, Ohio, 미국, 43213
    • Oregon
      • Medford, Oregon, 미국, 97504
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
      • Charleston, South Carolina, 미국, 29407
      • Greer, South Carolina, 미국, 29651
      • Mount Pleasant, South Carolina, 미국, 29464
      • Spartanburg, South Carolina, 미국, 29303
    • Texas
      • Austin, Texas, 미국, 78705
      • Dallas, Texas, 미국, 75231
      • Houston, Texas, 미국, 77036
      • Plano, Texas, 미국, 75024
      • San Antonio, Texas, 미국, 78229
      • San Antonio, Texas, 미국, 78228
    • Utah
      • Salt Lake City, Utah, 미국, 84121
      • Salt Lake City, Utah, 미국, 84102
      • South Jordan, Utah, 미국, 84095
    • Virginia
      • Burke, Virginia, 미국, 22015
  • 캐나다
      • Quebec, 캐나다, G1W 4R4
    • British Columbia
      • Victoria, British Columbia, 캐나다, V8V 4A1
    • Ontario
      • Brampton, Ontario, 캐나다, L6T 0G1
      • London, Ontario, 캐나다, N5W 6A2
      • Newmarket, Ontario, 캐나다, L3Y 5GB
      • Toronto, Ontario, 캐나다, M9W 4L6
      • Toronto, Ontario, 캐나다, M9V 4B4
    • Quebec
      • Mirabel, Quebec, 캐나다, J7J 2K8
      • Montreal, Quebec, 캐나다, H4N 2W2
      • Sherbrooke, Quebec, 캐나다, J1H 1Z1

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Able to provide written informed consent and adhere to the study visit schedule and treatment
  • Diagnosed with Type 2 diabetes mellitus as defined in the American Diabetes Association Standards of Medical Care in Diabetes 2015
  • Male or female ≥ 18 and ≤ 70 years of age
  • Screening fasting C-peptide > 0.5 ng/mL
  • Women of child bearing potential (WOCBP) must be willing to use double-barrier contraception for the entire study
  • WOCBP must have a negative pregnancy test (human chorionic gonadotropin, beta subunit [βhCG]) before entering the Lead-in Period
  • Body mass index ≥ 25 kg/m2 and ≤ 45 kg/m2 at the Screening Visit
  • On stable (≥ 8 weeks) metformin monotherapy ≥ 1000 mg/day
  • Screening HbA1c ≥ 7.0% and ≤ 10%
  • Taking ≥ 80% and ≤ 120% of both dispensed DS-8500a placebo tablets and sitagliptin placebo capsules during the Lead-in Period

Exclusion Criteria:

  • History of type 1 diabetes and/or history of ketoacidosis
  • History of insulin use for > 2 weeks within 2 months prior to the Screening Visit
  • Two or more readings of fasting Self-monitoring of Blood Glucose (SMBG) > 240 mg/dL or worsening symptoms of hyperglycemia with one SMBG level of > 240 mg/dL during the second week of Lead-in Period, confirmed by laboratory measurement
  • Screening hemoglobin <12 g/dL for males and <11 g/dL for females
  • Blood donation within 2 months prior to the Screening Visit or plans to donate blood or blood products during the study
  • Subjects after bariatric surgery or any gastric bypass
  • Screening thyroid stimulating hormone (TSH) levels not within normal range (based on reference laboratory values )
  • Screening Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 2.0 x upper limit of normal (ULN), and/or total bilirubin > 1.5 x ULN. If a subject has total bilirubin > 1.5 ULN, unconjugated and conjugated bilirubin fractions should be analyzed and only subjects documented to have Gilbert's syndrome may be enrolled
  • Screening Serum creatinine ≥ 1.5 mg/dL for males and ≥ 1.4 mg/dL for females, or creatinine clearance (CrCl) < 50 mL/min for both males and females
  • Screening Creatine kinase (CK) > 3.0 × ULN
  • History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, peripheral arterial event or any revascularization procedure during the 6 months prior to the Screening Visit or planned vascular procedures or surgery during study period
  • History of congestive heart failure (CHF)

  • Exclusionary concomitant medications:

    a. Eight weeks prior to screening and throughout the duration of the study:

  • Any diabetes medication other than metformin; any prescription or over the counter medication for weight-loss.
  • Systemic corticosteroids (including nasal and inhaled), with the exception of use of topical and ophthalmic corticosteroids.
  • Rosuvastatin > 20 mg daily. b. During treatment periods, additional medications will be prohibited based on potential drug-drug interaction (DDI) (see Section 5.6)
  • Subjects with anticipated interruption in metformin or study drug use during the course of the clinical trial (e.g., due to an imaging procedure involving iodinated contrast media)
  • Subjects in whom treatment with sitagliptin 100 mg is contraindicated ( e.g., known hypersensitivity or intolerance to sitagliptin) or may not be medically advisable (e.g., history of pancreatitis)
  • Abuse of or dependence on prescription medications, illicit drugs, or alcohol within the last 1 year
  • Any history of a malignancy other than basal cell carcinoma within the past 5 years
  • Pregnancy or breast-feeding, or intent to become pregnant during the study period
  • Known (or evidence of) infection with human immunodeficiency virus
  • Any condition, laboratory abnormality, or concomitant therapy which, in the opinion of the Investigator, might pose a risk to the subject or make participation not in the subject's best interest
  • Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study or is receiving other investigational agents
  • A direct or familial relationship with the Sponsor, Investigator, or site personnel affiliated with the study

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: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: DS-8500a 25mg
One DS-8500a 25 mg tablet, 2 placebo tablets, and one placebo capsule in a once-daily oral dose
의약품: DS-8500a 25mg
DS-8500a 25mg tablet for oral administration
다른 이름들:
  • 조사 제품
의약품: Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
다른 이름들:
  • 위약
의약품: Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
다른 이름들:
  • 위약
실험적: DS-8500a 50 mg
Two DS-8500a 25 mg tablets, 1 placebo tablet, and one placebo capsule in a once-daily oral dose
의약품: DS-8500a 25mg
DS-8500a 25mg tablet for oral administration
다른 이름들:
  • 조사 제품
의약품: Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
다른 이름들:
  • 위약
의약품: Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
다른 이름들:
  • 위약
실험적: DS-8500a 75 mg
Three DS-8500a 25 mg tablets and one placebo capsule in a once-daily oral dose
의약품: DS-8500a 25mg
DS-8500a 25mg tablet for oral administration
다른 이름들:
  • 조사 제품
의약품: Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
다른 이름들:
  • 위약
위약 비교기: Placebo
Three placebo tablets and one placebo capsule in a once-daily oral dose
의약품: Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
다른 이름들:
  • 위약
의약품: Placebo Capsule
Placebo matching sitagliptin over-capsule for oral administration
다른 이름들:
  • 위약
활성 비교기: Sitagliptin 100 mg
Three placebo tablets and one sitagliptin 100 mg over-capsule in a once-daily oral dose
의약품: Placebo Tablet
Placebo matching DS-8500a tablet for oral administration
다른 이름들:
  • 위약
의약품: Sitagliptin 100 mg
Two sitagliptin 50 mg tablets, over-encapsulated to provide a once-daily dose of 100 mg, for oral administration
다른 이름들:
  • 야누비아

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
기간: Baseline, Week 12
Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the three-month average glucose concentration in the blood. Target HbA1c for Type 2 diabetics was less than 7% at the time of this trial. Negative scores show improvement from baseline.
Baseline, Week 12

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Total Cholesterol (TC) at Week 12
기간: Baseline, Week 12
Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.
Baseline, Week 12
Change From Baseline in LDL-C at Week 12
기간: Baseline, Week 12
LDL-C is known as the "bad" cholesterol, so a lower score (negative change) means improvement.
Baseline, Week 12
Change From Baseline in HDL-C at Week 12
기간: Baseline, Week 12
HDL-C is known as the "good" cholesterol, so a higher score (positive change) means improvement.
Baseline, Week 12
Change From Baseline in Non-HDL-C at Week 12
기간: Baseline, Week 12
Non-HDL-C is the measure of "bad" cholesterol in the blood, including triglycerides and LDL-C, so a negative change means improvement. The equation for Non-HDL-C = LDL-C + (triglycerides/5).
Baseline, Week 12
Change From Baseline in Triglycerides at Week 12
기간: Baseline, Week 12
Triglycerides are a type of fat found in the blood. The body uses them for energy. Some triglycerides are needed for good health. But high triglycerides might raise the risk of heart disease. Since Type 2 diabetics tend to have high triglycerides, a negative change means improvement.
Baseline, Week 12
Change From Baseline in Area-Under-the Curve 0-3 Hours (AUC0-3h) of Plasma Glucose (PG) in Response to the Mixed Meal Tolerance Test (MMTT) at Week 4
기간: Baseline, Week 4
The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement.
Baseline, Week 4
Change From Baseline in AUC0-3h of PG in Response to the MMTT at Week 12
기간: Baseline, Week 12
The MMTT requires a participant to drink a "mixed meal," such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement.
Baseline, Week 12
Change From Baseline in Maximum Concentration (Cmax) of PG in Response to MMTT at Week 4
기간: Baseline, Week 4
Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.
Baseline, Week 4
Change From Baseline in Cmax of PG in Response to MMTT at Week 12
기간: Baseline, Week 12
Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.
Baseline, Week 12
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 2
기간: Baseline, Week 2
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Baseline, Week 2
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4
기간: Baseline, Week 4
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Baseline, Week 4
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 8
기간: Baseline, Week 8
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Baseline, Week 8
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
기간: Baseline, Week 12
Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.
Baseline, Week 12
Count of Participants With HbA1c Less Than 7.0% at Week 12
기간: Week 12
HbA1C less than 7% is the success goal for many Type 2 diabetics.
Week 12

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Daiichi Sankyo, Inc.

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

2016년 1월 1일

기본 완료 (실제)

2017년 1월 31일

연구 완료 (실제)

2017년 1월 31일

연구 등록 날짜

최초 제출

2016년 1월 4일

QC 기준을 충족하는 최초 제출

2016년 1월 4일

처음 게시됨 (추정)

2016년 1월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 2월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 2월 8일

마지막으로 확인됨

2018년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • DS8500-A-U202

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD 공유 기간

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD 공유 액세스 기준

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD 공유 지원 정보 유형

  • 연구 프로토콜
  • 통계 분석 계획(SAP)
  • 임상 연구 보고서(CSR)

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

DS-8500a 25mg에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Denmark

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다