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A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin

5 juli 2017 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

206

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Anaheim, California, Förenta staterna, 92801
        • Anaheim Clinical Trials, LLC
      • Los Angeles, California, Förenta staterna, 90057
        • National Research Institute
      • Orange, California, Förenta staterna, 92868
        • NRC Research Institute
      • Roseville, California, Förenta staterna, 95661
        • Sierra Clinical Research
      • Spring Valley, California, Förenta staterna, 91978
        • Encompass Clinical Research
      • Upland, California, Förenta staterna, 91786
        • Empire Clinical Research
      • Walnut Creek, California, Förenta staterna, 94598
        • Diablo Clinical Research, Inc
    • Florida
      • Coral Gables, Florida, Förenta staterna, 33134
        • Clinical Research of South Florida
      • DeLand, Florida, Förenta staterna, 32720
        • Avail Clinical Research, LLC
      • Miami, Florida, Förenta staterna, 33135
        • Suncoast Research Group, LLC
      • South Miami, Florida, Förenta staterna, 33143
        • QPS-MRA, LLC (Miami research Associates)
      • West Palm Beach, Florida, Förenta staterna, 33409
        • Palm Beach Research Center
    • Georgia
      • Sandy Springs, Georgia, Förenta staterna, 30328
        • WR-Mount Vernon Clinical Research, LLC
    • Hawaii
      • Honolulu, Hawaii, Förenta staterna, 96814
        • East-West Medical Research Institute
    • Indiana
      • Indianapolis, Indiana, Förenta staterna, 46260
        • Midwest Institute for Clinical Research
    • Louisiana
      • Metairie, Louisiana, Förenta staterna, 70006
        • Crescent City Clinical Research Center, LLC
    • Missouri
      • Saint Louis, Missouri, Förenta staterna, 63141
        • St. Louis Clinical Trials, LC
    • Nevada
      • Las Vegas, Nevada, Förenta staterna, 89120
        • ALAS Science Clinical Research
    • New Jersey
      • Berlin, New Jersey, Förenta staterna, 08009
        • Comprehensive Clinical Research
      • Eatontown, New Jersey, Förenta staterna, 07724
        • Clinilabs Inc.
      • Marlton, New Jersey, Förenta staterna, 08053
        • Pharmaceutical Research Associates, Inc.
      • Trenton, New Jersey, Förenta staterna, 08611
        • TLB Research
    • North Carolina
      • Asheboro, North Carolina, Förenta staterna, 27203
        • Randolph Medical Associates
      • High Point, North Carolina, Förenta staterna, 27265
        • High Point Clinical Trials Center, LLC
    • North Dakota
      • Fargo, North Dakota, Förenta staterna, 58103
        • Lillestol Research, LLC
    • Ohio
      • Columbus, Ohio, Förenta staterna, 43213
        • Aventiv Research
    • Texas
      • Houston, Texas, Förenta staterna, 77081
        • Texas Center for Drug Development, Inc.
      • Houston, Texas, Förenta staterna, 77074
        • Juno Research, LLC
      • Katy, Texas, Förenta staterna, 77450
        • Juno Research, LLC
      • San Antonio, Texas, Förenta staterna, 78229
        • Clinical Trials of Texas, Inc.
      • Schertz, Texas, Förenta staterna, 78154
        • Northeast Clinical Research of San Antonio, LLC
    • Virginia
      • Richmond, Virginia, Förenta staterna, 23294
        • National Clinical Research - Richmond, Inc.
  • Kanada
    • Ontario
      • Brampton, Ontario, Kanada, L6T 0G1
        • Aggarwal and Associates Limited
      • Thornhill, Ontario, Kanada, L4J 8L7
        • LMC Clinical Research Inc. (Thornhill)
      • Toronto, Ontario, Kanada, M4G 3E8
        • LMC Clinical Research Inc. (Bayview)
      • Toronto, Ontario, Kanada, M9W 4L6
        • Manna Research
    • Quebec
      • Lévis, Quebec, Kanada, G6W 0M6
        • Manna Research Inc.
      • Mirabel, Quebec, Kanada, J7J 2K8
        • Omnispec Clinical Research, Inc.

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. 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
  2. Subjects who have been on a stable dose of metformin either alone or in combination with one additional acceptable OAD
  3. 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:

  1. Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;
  2. 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
  3. 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;
  4. Any medical condition possibly affecting study drug absorption (eg, gastrectomy or any area of intestinal resection, active inflammatory bowel disease or pancreatic insufficiency
  5. 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
  6. Subject with a positive result for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Ab) or hepatitis C virus (HCV) antibodies
  7. 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
  8. 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
  9. Subjects with an arm circumference >52 cm measured at the midpoint of the length of the upper arm;
  10. 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);
  11. Treatment with thiazolidinediones (TZDs), or subcutaneously administered anti diabetic agents (eg, insulin, exenatide, liraglutide, pramlintide) within 6 weeks prior to V1;
  12. Subjects with a known hypersensitivity or intolerance to a glucagon receptor antagonist, or known prior participation in a trial involving PF 06291874;

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
Läkemedel: Placebo
oral tablett
Experimentell: PF-06291874, 30 mg
Läkemedel: PF-06291874
study drug to be given as an oral tablet at 30, 60 or 100 mg
Experimentell: PF-06291874, 60 mg
Läkemedel: PF-06291874
study drug to be given as an oral tablet at 30, 60 or 100 mg
Experimentell: PF-06291874, 100 mg
Läkemedel: PF-06291874
study drug to be given as an oral tablet at 30, 60 or 100 mg

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 as Compared to Placebo
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in HbA1c (%) at Weeks 2, 4, and 8
Tidsram: 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
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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).
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Publikationer och användbara länkar

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Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2015

Primärt slutförande (Faktisk)

1 augusti 2016

Avslutad studie (Faktisk)

1 augusti 2016

Studieregistreringsdatum

Först inskickad

17 september 2015

Först inskickad som uppfyllde QC-kriterierna

17 september 2015

Första postat (Uppskatta)

18 september 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 augusti 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 juli 2017

Senast verifierad

1 juli 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • B4801010

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