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- Klinische Studie NCT01059825
Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)
15. August 2018 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
375
Phase
- Phase 2
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Placebo-Komparator: 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).
Andere Namen:
|
Experimental: 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).
Andere Namen:
Tablet, 1 mg, once daily for 84 days
|
Experimental: 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).
Andere Namen:
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
|
Experimental: 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).
Andere Namen:
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
|
Experimental: 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).
Andere Namen:
Tablet, 25 mg, once daily for 84 days
|
Aktiver Komparator: 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).
Andere Namen:
Tablet, 100 mg, once daily for 84 days
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Baseline Hemoglobin A1c (HbA1c)
Zeitfenster: Baseline
|
HbA1c is measured as percent.
|
Baseline
|
Change From Baseline in HbA1c at Week 12
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change From Baseline in HbA1C at Week 2
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline
|
Baseline
|
|
Percent Change From Baseline in Body Weight at Week 12
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Percent Change From Baseline in Body Weight at Week 8
Zeitfenster: Baseline and Week 8
|
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 Diastolic Blood Pressure at Week 12
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline
|
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
|
Baseline
|
Change From Baseline in Fasting Plasma Glucose at Week 12
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Week 12
|
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
|
Week 12
|
Percentage of Participants Achieving HbA1C <6.5% at Week 12
Zeitfenster: 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)
Zeitfenster: 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.
|
Up to 98 days
|
Number of Participants Who Discontinued Study Medication Due to an AE
Zeitfenster: 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.
|
Up to 84 days
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
24. Februar 2010
Primärer Abschluss (Tatsächlich)
20. Januar 2011
Studienabschluss (Tatsächlich)
20. Januar 2011
Studienanmeldedaten
Zuerst eingereicht
29. Januar 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Januar 2010
Zuerst gepostet (Schätzen)
1. Februar 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
13. September 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
15. August 2018
Zuletzt verifiziert
1. August 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Störungen des Glukosestoffwechsels
- Stoffwechselerkrankungen
- Erkrankungen des endokrinen Systems
- Diabetes Mellitus
- Diabetes mellitus, Typ 2
- Hypoglykämische Mittel
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Hormone
- Hormone, Hormonersatzstoffe und Hormonantagonisten
- Protease-Inhibitoren
- Inkretine
- Natrium-Glucose-Transporter 2-Inhibitoren
- Dipeptidyl-Peptidase IV-Inhibitoren
- Metformin
- Sitagliptinphosphat
- Ertugliflozin
Andere Studien-ID-Nummern
- 8835-016
- B1521006 (Andere Kennung: Pfizer protocol number)
- 2009-017131-18 (EudraCT-Nummer)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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