A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin
5 de julho de 2017 atualizado por: Pfizer
A 12-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once Daily Pf-06291874 Administration In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
The purpose of this study is to determine whether PF-06291874 is effective in the treatment T2DM
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This will be a randomized, double blind, stratified, placebo controlled, parallel group study conducted in T2DM subjects receiving background metformin therapy.
Subjects will complete screening procedures to determine eligibility, followed by an 8 week metformin stabilization period prior to randomization.
In addition, subjects taking other OADs, in combination with metformin, will undergo a washout during this period, in which non metformin OAD medications will be temporarily discontinued for the duration of the trial.
Following confirmation of study eligibility criteria at randomization, subjects will be stratified into 2 groups based on the use of concomitant statin therapy.
Each stratum will be randomized across treatment groups, such that the number of subjects taking concomitant statin therapy and those not taking statin therapy will be approximately balanced across treatment groups.
Tipo de estudo
Intervencional
Inscrição (Real)
206
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Ontario
-
Brampton, Ontario, Canadá, L6T 0G1
- Aggarwal and Associates Limited
-
Thornhill, Ontario, Canadá, L4J 8L7
- LMC Clinical Research Inc. (Thornhill)
-
Toronto, Ontario, Canadá, M4G 3E8
- LMC Clinical Research Inc. (Bayview)
-
Toronto, Ontario, Canadá, M9W 4L6
- Manna Research
-
-
Quebec
-
Lévis, Quebec, Canadá, G6W 0M6
- Manna Research Inc.
-
Mirabel, Quebec, Canadá, J7J 2K8
- Omnispec Clinical Research, Inc.
-
-
-
-
California
-
Anaheim, California, Estados Unidos, 92801
- Anaheim Clinical Trials, LLC
-
Los Angeles, California, Estados Unidos, 90057
- National Research Institute
-
Orange, California, Estados Unidos, 92868
- NRC Research Institute
-
Roseville, California, Estados Unidos, 95661
- Sierra Clinical Research
-
Spring Valley, California, Estados Unidos, 91978
- Encompass Clinical Research
-
Upland, California, Estados Unidos, 91786
- Empire Clinical Research
-
Walnut Creek, California, Estados Unidos, 94598
- Diablo Clinical Research, Inc
-
-
Florida
-
Coral Gables, Florida, Estados Unidos, 33134
- Clinical Research of South Florida
-
DeLand, Florida, Estados Unidos, 32720
- Avail Clinical Research, LLC
-
Miami, Florida, Estados Unidos, 33135
- Suncoast Research Group, LLC
-
South Miami, Florida, Estados Unidos, 33143
- QPS-MRA, LLC (Miami research Associates)
-
West Palm Beach, Florida, Estados Unidos, 33409
- Palm Beach Research Center
-
-
Georgia
-
Sandy Springs, Georgia, Estados Unidos, 30328
- WR-Mount Vernon Clinical Research, LLC
-
-
Hawaii
-
Honolulu, Hawaii, Estados Unidos, 96814
- East-West Medical Research Institute
-
-
Indiana
-
Indianapolis, Indiana, Estados Unidos, 46260
- Midwest Institute for Clinical Research
-
-
Louisiana
-
Metairie, Louisiana, Estados Unidos, 70006
- Crescent City Clinical Research Center, LLC
-
-
Missouri
-
Saint Louis, Missouri, Estados Unidos, 63141
- St. Louis Clinical Trials, LC
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89120
- ALAS Science Clinical Research
-
-
New Jersey
-
Berlin, New Jersey, Estados Unidos, 08009
- Comprehensive Clinical Research
-
Eatontown, New Jersey, Estados Unidos, 07724
- Clinilabs Inc.
-
Marlton, New Jersey, Estados Unidos, 08053
- Pharmaceutical Research Associates, Inc.
-
Trenton, New Jersey, Estados Unidos, 08611
- TLB Research
-
-
North Carolina
-
Asheboro, North Carolina, Estados Unidos, 27203
- Randolph Medical Associates
-
High Point, North Carolina, Estados Unidos, 27265
- High Point Clinical Trials Center, LLC
-
-
North Dakota
-
Fargo, North Dakota, Estados Unidos, 58103
- Lillestol Research, LLC
-
-
Ohio
-
Columbus, Ohio, Estados Unidos, 43213
- Aventiv Research
-
-
Texas
-
Houston, Texas, Estados Unidos, 77081
- Texas Center for Drug Development, Inc.
-
Houston, Texas, Estados Unidos, 77074
- Juno Research, LLC
-
Katy, Texas, Estados Unidos, 77450
- Juno Research, LLC
-
San Antonio, Texas, Estados Unidos, 78229
- Clinical Trials of Texas, Inc.
-
Schertz, Texas, Estados Unidos, 78154
- Northeast Clinical Research of San Antonio, LLC
-
-
Virginia
-
Richmond, Virginia, Estados Unidos, 23294
- National Clinical Research - Richmond, Inc.
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 70 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Males or non-childbearing potential females between the ages of 18 (or the minimum country specific age of consent if >18) and 70 years, inclusive, at the screening visit (V1) with the diagnosis of T2DM;Female subjects who are not of childbearing potential
- Subjects who have been on a stable dose of metformin either alone or in combination with one additional acceptable OAD
- HbA1c at the Screen Visit (V1), as assessed by study specific central laboratory, is 7-11% if on metformin monotherapy; is 6.5-9.5% if on dual combination therapy (metformin plus 1)
Exclusion Criteria:
- Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;
- Fasting plasma glucose levels >270 mg/dL (15.0 mmol/L) at the screening and run in visit, (as assessed by study specific central laboratory) confirmed by a single repeat, if deemed necessary
- History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class III IV heart failure, or transient ischemic attack within 6 months of screening;
- Any medical condition possibly affecting study drug absorption (eg, gastrectomy or any area of intestinal resection, active inflammatory bowel disease or pancreatic insufficiency
- Subjects with a creatinine clearance <60 mL/min as determined by the Cockcroft Gault equation (listed below) using serum creatinine measured at screening, confirmed via a single repeat, if deemed necessary
- Subject with a positive result for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Ab) or hepatitis C virus (HCV) antibodies
- Screening seated systolic blood pressure >160 mm Hg and/or diastolic blood pressure >105 mm Hg after at least a 5 minute rest. Blood pressure determined as the mean of triplicate measurements collected with approximately 2 minutes of rest between measurements
- Screening supine 12 lead ECG demonstrating a corrected QT (QTc) >470 msec; or a QRS interval >120 msec. If QTc exceeds 470 msec or QRS exceeds 120 msec, the ECG may be repeated 2 more times with an interval of 2-4 minutes between each measurement and the mean of the 3 values used to determine the subject's eligibility
- Subjects with an arm circumference >52 cm measured at the midpoint of the length of the upper arm;
- History (within the last 6 months) of regular alcohol consumption exceeding 14 drinks per week for men and 7 drinks a week for women. (1 drink = 5 ounces of wine (150 mL) or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor);
- Treatment with thiazolidinediones (TZDs), or subcutaneously administered anti diabetic agents (eg, insulin, exenatide, liraglutide, pramlintide) within 6 weeks prior to V1;
- Subjects with a known hypersensitivity or intolerance to a glucagon receptor antagonist, or known prior participation in a trial involving PF 06291874;
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Placebo
|
comprimido oral
|
|
Experimental: PF-06291874, 30 mg
|
study drug to be given as an oral tablet at 30, 60 or 100 mg
|
|
Experimental: PF-06291874, 60 mg
|
study drug to be given as an oral tablet at 30, 60 or 100 mg
|
|
Experimental: PF-06291874, 100 mg
|
study drug to be given as an oral tablet at 30, 60 or 100 mg
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 as Compared to Placebo
Prazo: Baseline, Week 12
|
HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study.
|
Baseline, Week 12
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in HbA1c (%) at Weeks 2, 4, and 8
Prazo: Baseline, Weeks 2, 4, 8
|
HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study.
n represented the available number of participants for analysis at post-baseline days.
|
Baseline, Weeks 2, 4, 8
|
|
Change From Baseline in Fasting Plasma Glucose at Weeks 2, 4, 8, and 12
Prazo: Baseline, Weeks 2,4,8 and 12
|
Fasting plasma glucose response changed from baseline at Weeks 2,4,8 and 12. Baseline was defined as the average of the measurements obtained during Day 14 visit window and Day 1 pre-dose measurement.
n represented the available number of participants for analysis at post-baseline days.
|
Baseline, Weeks 2,4,8 and 12
|
|
Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) <7% as Well as <6.5% at Week 12.
Prazo: Week 12
|
HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
|
Week 12
|
|
Number of Participants With Laboratory Test Abnormalities
Prazo: Baseline up to 98 days
|
The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed.
Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests.
|
Baseline up to 98 days
|
|
Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria
Prazo: Baseline up to Day 98
|
ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): >=140 milliseconds (msec); >=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=300 msec; >=25 percent (%) increase when baseline >200 msec; or increase >=50% when baseline less than or equal to (<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >=500 msec; increase from baseline >=30 - <60, >=60 msec.
|
Baseline up to Day 98
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Prazo: Baseline up to Day 98
|
Vital signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate.
Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), pulse rate <40 or greater than (>) 120 beats per minute (bpm).
|
Baseline up to Day 98
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Hypoglycemic Adverse Events (HAEs).
Prazo: Baseline up to Day 119
|
An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug; the event need not necessarily have a causal relationship with the treatment.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reasons: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.
An HAE was identified by characteristic symptoms or blood glucose levels.
Any events occurring following start of treatment (defined as blinded therapy, including single blind placebo administration on Day 14) or increasing in severity were counted as treatment emergent AE.
|
Baseline up to Day 119
|
|
Percent Changes From Baseline for Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Weeks 2, 4, 8 and 12
Prazo: Baseline, Weeks 2, 4, 8 and 12
|
Fasting low density lipoprotein-cholesterol (LDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.
|
Baseline, Weeks 2, 4, 8 and 12
|
|
Percent Changes From Baseline for Triglycerides at Weeks 2, 4, 8 and 12
Prazo: Baseline, Weeks 2, 4, 8 and 12
|
Triglycerides percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.
Triglycerides MMRM was not appropriate as the data were very skewed and not normally distributed, therefore per SAP non-parametric analysis were reported, presenting medians and CIs for medians, instead.
If the data had many outliers even after the log transformation the following non parametric analysis was presented instead of the MMRM.
An outlier was defined as any data point falling outside of 3.5 x standard deviations the median.
|
Baseline, Weeks 2, 4, 8 and 12
|
|
Percent Changes From Baseline for Total Cholesterol at Weeks 2, 4, 8 and 12
Prazo: Baseline, Weeks 2, 4, 8 and 12
|
Total cholesterol percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.
|
Baseline, Weeks 2, 4, 8 and 12
|
|
Percent Changes From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Weeks 2, 4, 8 and 12
Prazo: Baseline, Weeks 2, 4, 8 and 12
|
High density lipoprotein-cholesterol (HDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.
|
Baseline, Weeks 2, 4, 8 and 12
|
|
Percent Changes From Baseline for Non-High Density Lipoprotein (HDL) Cholesterol at Weeks 2, 4, 8 and 12
Prazo: Baseline, Weeks 2, 4, 8 and 12
|
Non-HDL-C percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.
|
Baseline, Weeks 2, 4, 8 and 12
|
|
Changes From Baseline in Body Weight at Weeks 2, 4, 8, and 12.
Prazo: Baseline, Weeks 2, 4, 8 and 12
|
The body weight change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.
|
Baseline, Weeks 2, 4, 8 and 12
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de outubro de 2015
Conclusão Primária (Real)
1 de agosto de 2016
Conclusão do estudo (Real)
1 de agosto de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
17 de setembro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de setembro de 2015
Primeira postagem (Estimativa)
18 de setembro de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de agosto de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de julho de 2017
Última verificação
1 de julho de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- B4801010
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .