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Completed

NCT Number: NCT01475461

Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes

B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

DRC Kft., Balatonfüred, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female

Exclusion criteria

  • patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory test results at screening

Treatment and study plan

Placebo

Drug

double-dummy placebo tablets administered once-daily for 84-days

PF-04937319 - 3mg

Drug

PF-04937319 3mg administered as tablets once-daily for 84-days

PF-04937319 - 20mg

Drug

PF-04937319 20mg administered as tablets once-daily for 84-days

PF-04937319 - 50mg

Drug

PF-04937319 50mg administered as tablets once-daily for 84-days

PF-04937319 - 100mg

Drug

PF-04937319 100mg administered as tablets once-daily for 84-days

Sitagliptin - 100mg

Drug

Sitagliptin 100mg administered as tablets once-daily for 84-days

Primary outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12

    Time frame: Baseline (Day 1), Week 12

    HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than (<) 6.5 percent (%) by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.

Secondary outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8

    Time frame: Baseline(Day 1), Week 2, 4, 8

    HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.

  2. Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14

    Time frame: Baseline (Day 1), Week 1, 2, 4, 8, 12, 14

  3. Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12

    Time frame: Week 12

    HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used and data are presented in categories of <6.5 percent and <7 percent.

  4. Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data

    Time frame: Baseline (Day 1) up to Week 14

    Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline>200 then percent change of >25% counts; if baseline <=200 then percent change of >50% counts]; QRS complex (percent change of >=50%); QT Fridericia's correction (QTcF) interval (change of >=30 to <60 millisecond [msec], and change of >=60 msec).

  5. Number of Participants With Increase/Decrease From Baseline Vital Signs Data

    Time frame: Baseline (Day 1) up to Week 14

    Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator's discretion.

  6. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

    Time frame: Baseline (Day 1) up to 14 days after last dose (up to 101 days)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

  7. Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode

    Time frame: Baseline (Day 1) up to Week 14

    A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE is defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.

  8. Number of Hypoglycemic Events (HAE) Episodes Per Participant

    Time frame: Baseline (Day 1) up to Week 14

    A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Median number of events per participant was reported

  9. Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14

    Time frame: Baseline (Day 1), Week 2, 4, 8 , 12 , 14

  10. Number of Participants With Abnormal Laboratory Values

    Time frame: Baseline (Day 1) up to Week 14

    Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal[LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety And Efficacy Of Pf-04937319 And Sitagliptin On Glycemic Control In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2011
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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