Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)
2018年8月15日 更新者：Merck Sharp & Dohme LLC
A 12-Week, Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Evaluate the Safety, Tolerability and Efficacy Of Once Daily PF-04971729 And Sitagliptin On Glycemic Control And Body Weight In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus.
Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
375
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
18年～70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:
- Participants with type 2 diabetes on stable doses of background medicines for management of the diabetes; aged 18-70 years; body mass index between 23-45 kg/m^2
Exclusion Criteria:
- Participants with type 1 diabetes, heart attack or stroke in last 6-months, uncontrolled blood pressure, significant kidney disease
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Placebo
Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
|
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Tablet, matching placebo to 100 mg, once daily for 84 days
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
他の名前：
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実験的：Ertugliflozin 1 mg
Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
|
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Tablet, matching placebo to 100 mg, once daily for 84 days
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
他の名前：
Tablet, 1 mg, once daily for 84 days
|
|
実験的：Ertugliflozin 5 mg
Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
|
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Tablet, matching placebo to 100 mg, once daily for 84 days
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
他の名前：
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
|
|
実験的：Ertugliflozin 10 mg
Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
|
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Tablet, matching placebo to 100 mg, once daily for 84 days
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
他の名前：
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
|
|
実験的：Ertugliflozin 25 mg
Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
|
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Tablet, matching placebo to 100 mg, once daily for 84 days
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
他の名前：
Tablet, 25 mg, once daily for 84 days
|
|
アクティブコンパレータ：Sitagliptin 100 mg
Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
|
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
他の名前：
Tablet, 100 mg, once daily for 84 days
他の名前：
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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 |
|---|---|---|
|
Baseline Hemoglobin A1c (HbA1c)
時間枠：Baseline
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HbA1c is measured as percent.
|
Baseline
|
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Change From Baseline in HbA1c at Week 12
時間枠：Baseline and Week 12
|
HbA1c is measured as percent.
The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward [LOCF]).
|
Baseline and Week 12
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in HbA1C at Week 2
時間枠：Baseline and Week 2
|
HbA1c is measured as percent.
The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
|
Baseline and Week 2
|
|
Change From Baseline in HbA1c at Week 4
時間枠：Baseline and Week 4
|
HbA1c is measured as percent.
The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
|
Baseline and Week 4
|
|
Change From Baseline in HbA1c at Week 8
時間枠：Baseline and Week 8
|
HbA1c is measured as percent.
The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF).
|
Baseline and Week 8
|
|
Baseline Body Weight
時間枠：Baseline
|
Baseline
|
|
|
Percent Change From Baseline in Body Weight at Week 12
時間枠：Baseline and Week 12
|
The percent change from baseline is the ([Week 12 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
|
Baseline and Week 12
|
|
Percent Change From Baseline in Body Weight at Week 2
時間枠：Baseline and Week 2
|
The percent change from baseline is the ([Week 2 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
|
Baseline and Week 2
|
|
Percent Change From Baseline in Body Weight at Week 4
時間枠：Baseline and Week 4
|
The percent change from baseline is the ([Week 4 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
|
Baseline and Week 4
|
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Percent Change From Baseline in Body Weight at Week 8
時間枠：Baseline and Week 8
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The percent change from baseline is the ([Week 8 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).
|
Baseline and Week 8
|
|
Baseline Systolic Blood Pressure
時間枠：Baseline
|
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
|
Baseline
|
|
Change From Baseline in Systolic Blood Pressure at Week 12
時間枠：Baseline and Week 12
|
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
|
Baseline and Week 12
|
|
Change From Baseline in Systolic Blood Pressure at Week 2
時間枠：Baseline and Week 2
|
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
|
Baseline and Week 2
|
|
Change From Baseline in Systolic Blood Pressure at Week 4
時間枠：Baseline and Week 4
|
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
|
Baseline and Week 4
|
|
Change From Baseline in Systolic Blood Pressure at Week 8
時間枠：Baseline and Week 8
|
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).
|
Baseline and Week 8
|
|
Baseline Diastolic Blood Pressure
時間枠：Baseline
|
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
|
Baseline
|
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Change From Baseline in Diastolic Blood Pressure at Week 12
時間枠：Baseline and Week 12
|
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
|
Baseline and Week 12
|
|
Change From Baseline in Diastolic Blood Pressure at Week 2
時間枠：Baseline and Week 2
|
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
|
Baseline and Week 2
|
|
Change From Baseline in Diastolic Blood Pressure at Week 4
時間枠：Baseline and Week 4
|
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
|
Baseline and Week 4
|
|
Change From Baseline in Diastolic Blood Pressure at Week 8
時間枠：Baseline and Week 8
|
Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.
The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).
|
Baseline and Week 8
|
|
Baseline Fasting Plasma Glucose
時間枠：Baseline
|
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
|
Baseline
|
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Change From Baseline in Fasting Plasma Glucose at Week 12
時間枠：Baseline and Week 12
|
The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF).
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
|
Baseline and Week 12
|
|
Change From Baseline in Fasting Plasma Glucose at Week 2
時間枠：Baseline and Week 2
|
The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF).
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
|
Baseline and Week 2
|
|
Change From Baseline in Fasting Plasma Glucose at Week 4
時間枠：Baseline and Week 4
|
The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF).
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
|
Baseline and Week 4
|
|
Change From Baseline in Fasting Plasma Glucose at Week 8
時間枠：Baseline and Week 8
|
The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF).
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
|
Baseline and Week 8
|
|
Percentage of Participants Achieving HbA1c <7% at Week 12
時間枠：Week 12
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Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
|
Week 12
|
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Percentage of Participants Achieving HbA1C <6.5% at Week 12
時間枠：Week 12
|
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
|
Week 12
|
|
Number of Participants Who Experienced an Advere Event (AE)
時間枠：Up to 98 days
|
An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Below table includes all data collected since the first dose of sponsor-provided metformin.
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Up to 98 days
|
|
Number of Participants Who Discontinued Study Medication Due to an AE
時間枠：Up to 84 days
|
An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication.
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Up to 84 days
|
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
協力者
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。
一般刊行物
- Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, Sweeney K. Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1297-1306. doi: 10.1002/cpdd.970. Epub 2021 Jul 2.
- Amin NB, Wang X, Jain SM, Lee DS, Nucci G, Rusnak JM. Dose-ranging efficacy and safety study of ertugliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin. Diabetes Obes Metab. 2015 Jun;17(6):591-598. doi: 10.1111/dom.12460. Epub 2015 Mar 31.
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 (実際)
2010年2月24日
一次修了 (実際)
2011年1月20日
研究の完了 (実際)
2011年1月20日
試験登録日
最初に提出
2010年1月29日
QC基準を満たした最初の提出物
2010年1月29日
最初の投稿 (見積もり)
2010年2月1日
学習記録の更新
投稿された最後の更新 (実際)
2018年9月13日
QC基準を満たした最後の更新が送信されました
2018年8月15日
最終確認日
2018年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 8835-016
- B1521006 (その他の識別子：Pfizer protocol number)
- 2009-017131-18 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
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。