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Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)

15 agosto 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

375

Fase

  • Fase 2

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
Droga: Placebo to Ertugliflozin
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Droga: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Droga: Metformin
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).
Altri nomi:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Sperimentale: 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
Droga: Placebo to Ertugliflozin
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Droga: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Droga: Metformin
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).
Altri nomi:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Droga: Ertugliflozin 1 mg
Tablet, 1 mg, once daily for 84 days
Sperimentale: 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
Droga: Placebo to Ertugliflozin
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Droga: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Droga: Metformin
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).
Altri nomi:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Droga: Ertugliflozin 5 mg
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
Sperimentale: Ertugliflozin 10 mg
Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
Droga: Placebo to Ertugliflozin
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Droga: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Droga: Metformin
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).
Altri nomi:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Droga: Ertugliflozin 5 mg
Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days
Sperimentale: Ertugliflozin 25 mg
Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
Droga: Placebo to Ertugliflozin
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Droga: Placebo to Sitagliptin
Tablet, matching placebo to 100 mg, once daily for 84 days
Droga: Metformin
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).
Altri nomi:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Droga: Ertugliflozin 25 mg
Tablet, 25 mg, once daily for 84 days
Comparatore attivo: Sitagliptin 100 mg
Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
Droga: Placebo to Ertugliflozin
Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days
Droga: Metformin
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).
Altri nomi:
  • Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Droga: Sitagliptin 100 mg
Tablet, 100 mg, once daily for 84 days
Altri nomi:
  • Januvia®, Tesavel®, Xelevia®, Ristaben®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Baseline Hemoglobin A1c (HbA1c)
Lasso di tempo: Baseline
HbA1c is measured as percent.
Baseline
Change From Baseline in HbA1c at Week 12
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in HbA1C at Week 2
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
Baseline
Percent Change From Baseline in Body Weight at Week 12
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
Laboratory measurements were performed after an overnight fast ≥8 hours in duration.
Baseline
Change From Baseline in Fasting Plasma Glucose at Week 12
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Merck Sharp & Dohme LLC

Collaboratori

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 febbraio 2010

Completamento primario (Effettivo)

20 gennaio 2011

Completamento dello studio (Effettivo)

20 gennaio 2011

Date di iscrizione allo studio

Primo inviato

29 gennaio 2010

Primo inviato che soddisfa i criteri di controllo qualità

29 gennaio 2010

Primo Inserito (Stima)

1 febbraio 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 settembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 agosto 2018

Ultimo verificato

1 agosto 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 8835-016
  • B1521006 (Altro identificatore: Pfizer protocol number)
  • 2009-017131-18 (Numero EudraCT)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Placebo to Ertugliflozin

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Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Switzerland

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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