A Study of Multiple Oral Doses of JNJ-41443532 in Patients With Type 2 Diabetes Mellitus
2013年10月17日 更新者：Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Double-Blind, Randomized, Placebo- and Active Comparator-Controlled, 4-Week Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of JNJ-41443532 in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the body does to the medication) and pharmacodynamics (what the medication does to the body) of treatment with JNJ-41443532 relative to treatment with placebo in type 2 diabetes mellitus participants.
調査の概要
詳細な説明
This is a randomized (the study medication is assigned by chance), double-blind (neither investigator nor participant knows the treatment that the participant receives), multicenter (study conducted at multiple sites), and placebo (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) and active comparator (an established effective treatment that is compared with a medication to test whether the medication has a real effect in a clinical study) controlled study (placebo or active comparator is compared with the study medication to test whether the study medication has a real effect in clinical study).
The study consists of 4 phases: screening phase (45 days before administration of study medication); pre-dosing run-in phase (a phase before a clinical study is commenced when no treatment is given.
In this study, participant's glucose level will be observed during run-in-phase: days 15 to 1 before administration of study medication); treatment phase, and follow-up phase (7 to 10 days after the last dose of the study medication).
Approximately 88 participants will be enrolled in this study.
All participants will be randomly assigned to 4 treatment arms: JNJ-41443532 250 mg; JNJ-41443532 1000 mg; pioglitazone arm; and placebo.
Safety evaluations will include assessment of adverse events including ocular assessments, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study.
The maximum study duration for each participant will be approximately 12 weeks.
研究の種類
介入
入学 (実際)
89
段階
- フェーズ2
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
25年～65年 (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:
- Diagnosed Type 2 Diabetes Mellitus (T2DM) for at least 3 months prior screening
- On a stable treatment regimen for at least 2 months prior screening
- Medically stable on the basis of physical examination, medical history, and clinical laboratory tests performed at screening and 2 days before administration of the study medication
- Fasting plasma glucose (FPG) concentrations between 140 mg/dL and 270 mg/dL on 2 days before administration of the study medication
- Agrees to protocol-defined use of effective contraception
Exclusion Criteria:
- History of other types of diabetes and complications or secondary forms of diabetes
- History of eating disorder or recent significant changes in body weight (ie, more or equal to 5 percent over 3 months prior to screening) due to dieting or nutritional treatments
- Taking antihyperglycemic agents (insulin, exenatide, and liraglutide) within 6 months or thiazolidinedione within 3 months of 2 days before administration of the study medication
- Clinically significant abnormal electrocardiogram
- History of, or currently active, significant illness or medical disorders, retinal disease, tuberculosis
- Clinically important serious infection, positive for serology at screening (hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus antibodies)
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：JNJ-41443532 250 mg
Participants will receive JNJ-41443532 250 mg in morning and evening for 28 days.
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Participants will receive JNJ-41443532 tablet(s) orally in JNJ-41443532 250 mg arm (1 X 250 mg) and JNJ-41443532 1000 mg arm (4 X 250 mg) in morning and evening, for 28 days.
Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.
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実験的：JNJ-41443532 1000 mg
Participants will receive JNJ-41443532 1000 mg (4 X 250 mg) in morning and evening for 28 days.
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Participants will receive JNJ-41443532 tablet(s) orally in JNJ-41443532 250 mg arm (1 X 250 mg) and JNJ-41443532 1000 mg arm (4 X 250 mg) in morning and evening, for 28 days.
Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.
|
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アクティブコンパレータ：Pioglitazone
Participants will receive pioglitazone 30 mg in morning for 28 days.
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Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.
Participants will receive tablet pioglitazone 30 mg orally in morning for 28 days.
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プラセボコンパレーター：Placebo
Participants will receive matching placebo for JNJ-41443532 and pioglitazone for 28 days.
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Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.
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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 |
|---|---|---|
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Change From Baseline (Day -1) to Day 28 in Twenty-Four-Hour Weighted Average Glucose (24-Hour WAG)
時間枠：From baseline (Day -1) to Day 28
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Difference is calculated as the change in 24-hour WAG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.
24-hour WAG is defined as the area under the plasma glucose concentration time curve over 0 to 24 hours, divided by 24.
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From baseline (Day -1) to Day 28
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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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Change From Baseline to Day 28 in Fasting Plasma Glucose (FPG)
時間枠：From baseline to Day 28
|
Difference is calculated as the change in FPG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.
|
From baseline to Day 28
|
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Change From Baseline to Day 28 in Insulin Secretion
時間枠：From baseline to Day 28
|
Difference is calculated as the change in insulin secretion in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.
Insulin secretion is measured by the absolute change in Homeostasis Model Assessment of steady state islet beta cell (HOMA-%B).
HOMA-%B calculated as: (360 multiplied by Insulin [pmol/L]) divided by ([Glucose {mg/dL} minus 63] multiplied by 6.945).
Higher value is better (signifies improvement relative to baseline).
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From baseline to Day 28
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Change From Baseline to Day 28 in Insulin Resistance
時間枠：From baseline to Day 28
|
Difference is calculated as the change in insulin resistance in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.
Insuline sensitivity is measured by absolute change in Homeostasis Model Assessment of insulin resistance (HOMA-IR).
Insulin sensitivity is HOMA-%S and HOMA-IR is the reciprocal of HOMA-%S.
HOMA-IR calculated as: (Glucose [mg/dL]) multiplied by Insulin [pmol/L]) divided by (405 multiplied by 6.945).
Lower value is better (signifies improvement relative to baseline).
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From baseline to Day 28
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Change From Baseline to Day 28 in Systemic Levels of Interleukin 6 (IL-6)
時間枠：From baseline to Day 28
|
Difference is calculated as the geometric mean change in IL-6 from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change.
IL-6 is a systemic inflammatory markers and is an independent predictors of insulin resistance and progression to type 2 diabetes mellitus.
IL-6 was not measured for pioglitazone guoup.
The unit of IL-6 is picograms per milliliter (pg/mL).
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From baseline to Day 28
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Change From Baseline to Day 28 in Systemic Levels of Interleukin 18 (IL-18)
時間枠：From baseline to Day 28
|
Difference is calculated as the geometric mean change in IL-18 from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change.
IL-18 was not measured for pioglitazone group.
The unit of IL-18 is picograms per milliliter (pg/mL)
|
From baseline to Day 28
|
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Change From Baseline to Day 28 in Systemic Levels of C-Reactive Protein (CRP)
時間枠：From baseline to Day 28
|
Difference is calculated as the geometric mean change in CRP from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change.
CRP was not measured for pioglitazone group.
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From baseline to Day 28
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Change From Baseline to Day 29 in Body Weight
時間枠：From baseline to Day 29
|
Difference is calculated as the change in body weight in Least Square Mean (LSM) from baseline to Day 29 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo).
The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.
|
From baseline to Day 29
|
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。
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
2010年12月1日
一次修了 (実際)
2011年6月1日
研究の完了 (実際)
2011年6月1日
試験登録日
最初に提出
2010年10月22日
QC基準を満たした最初の提出物
2010年10月28日
最初の投稿 (見積もり)
2010年10月29日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年12月11日
QC基準を満たした最後の更新が送信されました
2013年10月17日
最終確認日
2013年10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。