Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)
2019年11月8日 更新者：Merck Sharp & Dohme LLC
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Single Day Evaluation Of The Pharmacokinetic-Pharmacodynamic Effect Of Once And Twice Daily Oral Administration Of PF-04971729 In Patients With Type 2 Diabetes Mellitus
This is a Phase 1 randomized, double-blind, sponsor open, 4 arm, 2 way cross-over study using 2 cohorts.
The objective of the study is to evaluate the pharmacodynamics (PD) effects and the pharmacokinetic (PK) of single day dosing of 2 mg and 4 mg doses of ertugliflozin (Ertu, PF-04971729/MK-8835) each administered once vs twice daily (morning [AM] and evening [PM]) in adults with type 2 diabetes.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
52
段階
- フェーズ 1
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～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:
- Participants with type 2 diabetes mellitus, either treatment-naïve or on up to 2 acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.
Exclusion Criteria:
- Participants with type 1 diabetes mellitus, participants with stroke, unstable angina, heart attack in last 6-months, uncontrolled blood pressure.
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：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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 |
|---|---|
|
実験的：Cohort 1: Ertu 2 mg/Placebo (Pbo)→Ertu 1 mg/Ertu 1 mg
Period 1: Ertu 2 mg in the AM and Pbo in the PM for 1 day.
Period 2: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day.
There was a >= 7 day washout period between Period 1 and Period 2.
|
Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose
Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day
Placebo to ertugliflozin administered as a single dose
|
|
実験的：Cohort 1: Ertu 1 mg/Ertu 1 mg→Ertu 2 mg/Pbo
Period 1: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day.
Period 2: Ertu 2 mg in the AM and Pbo in the PM for 1 day.
There was a >= 7 day washout period between Period 1 and Period 2.
|
Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose
Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day
Placebo to ertugliflozin administered as a single dose
|
|
実験的：Cohort 2: Ertu 4 mg/Pbo→Ertu 2 mg/Ertu 2 mg
Period 1: Ertu 4 mg in the AM and Pbo in the PM for 1 day.
Period 2: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day.
There was a >= 7 day washout period between Period 1 and Period 2.
|
Placebo to ertugliflozin administered as a single dose
Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose
Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day
|
|
実験的：Cohort 2: Ertu 2 mg/Ertu 2 mg→Ertu 4 mg/Pbo
Period 1: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day.
Period 2: Ertu 4 mg in the AM and Pbo in the PM for 1 day.
There was a >= 7 day washout period between Period 1 and Period 2.
|
Placebo to ertugliflozin administered as a single dose
Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose
Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day
|
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 |
|---|---|---|
|
Cumulative Urinary Glucose Excretion Over 0 to 24 Hours
時間枠：0 to 24 hours after the morning dose
|
Urine for analysis of glucose was collected at prespecified intervals.
Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose).
The average amount of urinary glucose excreted from 0 to 24 hours after the morning dose is presented in the table below.
|
0 to 24 hours after the morning dose
|
|
Urinary Glucose Excretion by Time Period
時間枠：At 0-4 hrs, 4-8 hrs, 8-12 hrs, and 12-24 hrs after the AM dose (up to 24 hours)
|
Urine for analysis of glucose was collected at prespecified intervals.
Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose).
The average amount of urinary glucose excreted during the pre-specified time frame is presented in the table below.
|
At 0-4 hrs, 4-8 hrs, 8-12 hrs, and 12-24 hrs after the AM dose (up to 24 hours)
|
|
24-hour Weighted Mean Plasma Glucose
時間枠：Up to 24 hours
|
Blood was collected during each treatment period at pre-dose (fasted) on Day 1 (Hour 0) and post-dose (fed) on Day 1 at 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 12.5, 13, 14, 15, 16, 18, and 24 hours.
|
Up to 24 hours
|
|
Weighted Mean Postprandial Plasma Glucose
時間枠：At 0-5 hours, 5-12 hrs, and 12-18 hrs after the morning dose (up to 18 hours)
|
The weighted mean postprandial glucose over the specified intervals were analyzed by cohort.
|
At 0-5 hours, 5-12 hrs, and 12-18 hrs after the morning dose (up to 18 hours)
|
|
Fasting Plasma Glucose
時間枠：Up to 24 hours
|
Blood samples were to be collected following a fast from all food and drink (except water) for at least 8 hours.
Fasting Plasma Glucose was collected as part of the assessment of weighted mean 24-hour plasma glucose.
As such, it was not specified as an endpoint in the Statistical Analysis Plan and was not analyzed or summarized separately.
|
Up to 24 hours
|
|
Fasting C-peptide
時間枠：Up to 24 hours (0 and 24 hours)
|
The fasting c-peptide was analyzed by cohort using a mixed-effects model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.
|
Up to 24 hours (0 and 24 hours)
|
|
Number of Participants Experiencing an Adverse Event
時間枠：Up to 16 days
|
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device.
The table below includes all data collected since the first dose of study drug.
|
Up to 16 days
|
|
Number of Participants Discontinuing Study Drug Due to an Adverse Event
時間枠：Up to 8 days (Day 1 in each dosing period)
|
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device.
The table below includes all data collected since the first dose of study drug.
Data include participants discontinued due to adverse events, participants with dose reduced or temporary discontinuation due to adverse events.
|
Up to 8 days (Day 1 in each dosing period)
|
|
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin
時間枠：0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
|
Pharmacokinetic (PK) parameter of AUClast for study drug.
Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
|
0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
|
|
Maximum Plasma Concentration (Cmax) of Ertugliflozin
時間枠：0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
|
PK parameter of Cmax for study drug.
Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
|
0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
|
|
Time Taken to Reach the Maximum Observed Plasma Concentration (Tmax) of Ertugliflozin
時間枠：0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
|
PK parameter of Tmax for study drug.
Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
|
0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
|
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.
- Dawra VK, Liang Y, Shi H, Bass A, Hickman A, Terra SG, Zhou S, Cutler D, Sahasrabudhe V. A PK/PD study comparing twice-daily to once-daily dosing regimens of ertugliflozin in healthy subjects . Int J Clin Pharmacol Ther. 2019 Apr;57(4):207-216. doi: 10.5414/CP203343.
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17日
一次修了 (実際)
2010年4月7日
研究の完了 (実際)
2010年4月7日
試験登録日
最初に提出
2010年1月20日
QC基準を満たした最初の提出物
2010年1月20日
最初の投稿 (見積もり)
2010年1月22日
学習記録の更新
投稿された最後の更新 (実際)
2019年11月21日
QC基準を満たした最後の更新が送信されました
2019年11月8日
最終確認日
2019年11月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 8835-040
- B1521007 (その他の識別子：Pfizer Protocol Number)
- MK-8835-040 (その他の識別子：Merck Protocol Number)
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
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