Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes
2016年3月4日 更新者：Takeda
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 mg and 50 mg Compared With Placebo in Subjects With Type 2 Diabetes
The purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam), once daily (QD), in participants with type 2 diabetes mellitus (T2DM).
調査の概要
詳細な説明
TAK-875 is being developed at Takeda Development Center, Inc. as an adjunct to diet and exercise to improve glycemic control in patients with T2DM.
This study will investigate TAK-875 in participants with type 2 diabetes mellitus who have been treated with only diet and exercise for at least 12 weeks prior to Screening, who have taken ≤7 days of any antidiabetic agent within the 12 weeks prior to Screening, and whose glycemic control is inadequate.
研究の種類
介入
入学 (実際)
421
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Dothan、Alabama、アメリカ
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Muscle Shoals、Alabama、アメリカ
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Arizona
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Goodyear、Arizona、アメリカ
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Phoenix、Arizona、アメリカ
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California
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Long Beach、California、アメリカ
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North Hollywood、California、アメリカ
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Norwalk、California、アメリカ
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Palm Springs、California、アメリカ
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Pismo Beach、California、アメリカ
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Florida
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Boynton Beach、Florida、アメリカ
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Bradenton、Florida、アメリカ
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Coral Gables、Florida、アメリカ
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Hialeah、Florida、アメリカ
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Largo、Florida、アメリカ
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New Port Richey、Florida、アメリカ
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Orlando、Florida、アメリカ
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Pembroke Pines、Florida、アメリカ
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Georgia
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Decatur、Georgia、アメリカ
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Illinois
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Chicago、Illinois、アメリカ
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Indiana
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Avon、Indiana、アメリカ
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Greenfield、Indiana、アメリカ
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Muncie、Indiana、アメリカ
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Iowa
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Council Bluffs、Iowa、アメリカ
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Kansas
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Topeka、Kansas、アメリカ
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Kentucky
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Lexington、Kentucky、アメリカ
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Maryland
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Oxon Hill、Maryland、アメリカ
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Michigan
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Flint、Michigan、アメリカ
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Mississippi
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Picayune、Mississippi、アメリカ
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Nebraska
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Omaha、Nebraska、アメリカ
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New Jersey
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Elizabeth、New Jersey、アメリカ
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North Carolina
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Charlotte、North Carolina、アメリカ
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Greensboro、North Carolina、アメリカ
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Mooresville、North Carolina、アメリカ
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Morganton、North Carolina、アメリカ
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Raleigh、North Carolina、アメリカ
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Ohio
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Maumee、Ohio、アメリカ
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ
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Pennsylvania
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Harleysville、Pennsylvania、アメリカ
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Levittown、Pennsylvania、アメリカ
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Uniontown、Pennsylvania、アメリカ
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South Carolina
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Greer、South Carolina、アメリカ
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Tennessee
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Crossville、Tennessee、アメリカ
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Texas
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Carrollton、Texas、アメリカ
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Dallas、Texas、アメリカ
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El Pasco、Texas、アメリカ
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Fort Worth、Texas、アメリカ
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Ft. Worth、Texas、アメリカ
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Houston、Texas、アメリカ
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Irving、Texas、アメリカ
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New Braunfels、Texas、アメリカ
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San Antonio、Texas、アメリカ
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Spring、Texas、アメリカ
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Tomball、Texas、アメリカ
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Utah
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Salt Lake City、Utah、アメリカ
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Virginia
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Burke、Virginia、アメリカ
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Manassas、Virginia、アメリカ
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Ciudad Autonoma Buenos Aires、アルゼンチン
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Cordoba、アルゼンチン
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Corrientes、アルゼンチン
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Mendoza、アルゼンチン
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Ciudad Autonoma Buenos Aires
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Ciudad Autonoma de Buenos Aires、Ciudad Autonoma Buenos Aires、アルゼンチン
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Cordoba
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Villa Cabrera、Cordoba、アルゼンチン
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Dnipropetrovsk、ウクライナ
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Kharkiv、ウクライナ
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Kyiv、ウクライナ
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Odesa、ウクライナ
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Simferopol、ウクライナ
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Ternopil、ウクライナ
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Vinnytsia、ウクライナ
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Zaporizhzhia、ウクライナ
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Guatemala、グアテマラ
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Guatemala City、グアテマラ
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Quetzaltenango、グアテマラ
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Zacapa、グアテマラ
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Banska Bystrica、スロバキア
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Bratislava、スロバキア
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Dolny Kubin、スロバキア
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Komarno、スロバキア
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Levice、スロバキア
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Pezinok、スロバキア
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Prievidza、スロバキア
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Trebisov、スロバキア
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Trencin、スロバキア
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Zilina、スロバキア
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Budapest、ハンガリー
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Debrecen、ハンガリー
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Kecskemet、ハンガリー
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Komarom、ハンガリー
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Szikszo、ハンガリー
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Zalaegerszeg、ハンガリー
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Byala、ブルガリア
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Plovdiv、ブルガリア
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Ruse、ブルガリア
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Sofia、ブルガリア
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Varna、ブルガリア
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Distrito Federal
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Mexico、Distrito Federal、メキシコ
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Nuevo León
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Monterrey、Nuevo León、メキシコ
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- The participant is male or female and 18 years of age or older with a historical diagnosis of T2DM.
- The participant has been treated with only diet and exercise for at least 12 weeks prior to Screening and has an HbA1c concentration between 7.0 % and 10.5%, inclusive, at Screening.
- The participant has received ≤7 days of any antidiabetic agent within 12 weeks prior to Screening.
- The participant has a body mass index (BMI) ≤45 kg/m^2 at Screening.
- Participants regularly using other, non-excluded medications must be on a stable dose for at least 4 weeks prior to Screening. However, as needed (PRN) use of prescription or over-the-counter medication is allowed at the discretion of the investigator.
- The participant is able and willing to monitor glucose with a home glucose monitor and consistently record his or her own blood glucose concentrations and complete participant diaries.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of the informed consent throughout the duration of the study and for 30 days after the last dose of study drug.
Additional Inclusion Criteria prior to Randomization
- The participant has an HbA1c concentration between 7.0 and 10.5%, inclusive, and a fasting plasma glucose (FPG) ≤270 mg/dL (≤15.0 mmol/L) at Week -1 Visit. (If the participant does not qualify for randomization based on these criteria, the assessments may be repeated weekly, for a maximum of 2 additional weeks).
- The participant's overall compliance with single-blind study medication during the Placebo Run-in Period is at least 75% and does not exceed 125% based on tablet counts performed by the study staff.
- A female participant of childbearing potential must have a negative urine hCG pregnancy test at Baseline (Visit 4) prior to Randomization and prior to administration of the first dose of double-blind study medication
Exclusion Criteria:
- The participant has received any investigational compound within 30 days prior to Screening or has received an investigational antidiabetic drug within 3 months prior to Screening.
- The participant has been randomized in a previous TAK-875 study.
- The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, or sibling; biological or legally adopted) or may consent under duress.
- The participant donated or received any blood products within 12 weeks prior to Screening or is planning to donate blood during the study.
- The participant has a hemoglobin ≤12 g/dL (≤120 gm/L) for males and ≤10 g/dL (≤100 gm/L) for females at Screening.
- The participant has a systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥95 mm Hg at Screening (If the participant meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement and decision will be made based on the second measurement).
- The participant has a history of cancer that has been in remission for <5 years prior to Screening. A history of basal cell carcinoma or stage 1 squamous cell carcinoma of the skin is allowed.
- The participant has an alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >2.0x the upper limit of normal (ULN) at Screening.
- The participant has a total bilirubin level greater than the ULN at Screening. Exception: if a participant has documented Gilbert's Syndrome, the participant will be allowed with an elevated bilirubin level per the investigator's discretion.
- The participant has a serum creatinine ≥1.5 mg/dL(≥133 µmol/L) [males] and ≥1.4 mg/dL (≥124 µmol/L) [females] and/or estimated glomerular filtration rate (GFR) <60 mL/min/1.73m^2 at Screening.
- The participant has uncontrolled thyroid disease.
- The participant has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
- The participant has had gastric banding or gastric bypass surgery within one year prior to Screening.
- The participant has a known history of infection with human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
- The participant had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal electrocardiogram (ECG), cerebrovascular accident or transient ischemic attack within 3 months prior or at Screening.
- The participant has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s) to any component of TAK-875.
- The participant has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse within 2 years prior to Screening.
- The participant received excluded medications prior to Screening or is expected to receive excluded medication.
- If female, the participant is pregnant (confirmed by laboratory testing, i.e., serum human chorionic gonadotropin (hCG), in females of childbearing potential) or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
- The participant is unable to understand verbal or written English or any other language for which a certified translation of the approved informed consent is available.
- The participant has any other physical or psychiatric disease or condition that in the judgment of the investigator may affect life expectancy or may make it difficult to successfully manage and follow the participant according to the protocol.
Additional Exclusion Criteria prior to Randomization
- The participant received excluded medications during the Placebo Run-in Period. (Topical and inhaled corticosteroids are allowed).
- The participant has a systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥95 mm Hg at Baseline (Visit 4) (If the participant meets this exclusion criterion, the assessment may be repeated once at least 30 minutes after the initial measurement and decision will be made based on the second measurement).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：Placebo
Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
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ファシグリファムプラセボマッチング錠剤
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実験的：Fasiglifam 25 mg
Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
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ファシグリファム錠
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実験的：Fasiglifam 50 mg
Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
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ファシグリファム錠
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
時間枠：Baseline and Week 24
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The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to Baseline.
A mixed model repeated measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.
|
Baseline and Week 24
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of HbA1c <7%
時間枠：Week 24
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The incidence (percentage of participants with) HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of less than seven percent for target glycemic control at Week 24.
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Week 24
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Change From Baseline in Fasting Plasma Glucose
時間枠：Baseline and Week 24
|
The change between the fasting plasma glucose value collected at Week 24 relative to Baseline measured in milligrams per deciliter (mg/dL).
A MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.
|
Baseline and Week 24
|
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Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Meal Tolerance Test (MTT)
時間枠：Baseline and Week 24
|
The change between the value of glucose after a meal, measured by the meal tolerance test collected at Week 24 relative to Baseline.
Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal measured in millimoles per liter (mmol/L).
An Analysis of Covariance (ANCOVA) model with treatment and country as fixed factors and Baseline value as covariate was used for analysis.
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Baseline and Week 24
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Senior Medical Director、Takeda
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年11月1日
一次修了 (実際)
2013年7月1日
研究の完了 (実際)
2013年7月1日
試験登録日
最初に提出
2011年10月18日
QC基準を満たした最初の提出物
2011年10月18日
最初の投稿 (見積もり)
2011年10月20日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年4月5日
QC基準を満たした最後の更新が送信されました
2016年3月4日
最終確認日
2016年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。