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Trial record 1 of 1 for:    NCT01517373
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Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin

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ClinicalTrials.gov Identifier: NCT01517373
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 20, 2012
First Posted Date  ICMJE January 25, 2012
Results First Submitted Date  ICMJE December 6, 2016
Results First Posted Date  ICMJE January 31, 2017
Last Update Posted Date January 31, 2017
Study Start Date  ICMJE February 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2016)
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 was reported.
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2012)
Change from Baseline over 12-weeks in glycosylated hemoglobin - HbA1C [ Time Frame: up to 12 weeks ]
Change History Complete list of historical versions of study NCT01517373 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2016)
  • Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8 [ Time Frame: Baseline (Day 1), Week 2, 4, 6, 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 less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.
  • Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12 [ Time Frame: Baseline (Day 1), Week 2, 4, 6, 8, 12 ]
  • 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 less than 6.5 percent by the study-specific central laboratory used and data are presented in categories of less than 6.5 percent and less than 7 percent.
  • Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data [ Time Frame: Baseline (Day 1) up to Week 14 ]
    Participants who met the criteria for increase from baseline in ECG data were reported. Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline value was >200 then percent change of >25% counts; if baseline value was <=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).
  • 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.
  • 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 of study treatment (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.
  • Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode [ Time Frame: Baseline (Day 1) up to Week 14 ]
    A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. HAE was 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.
  • Number of Hypoglycemic Events (HAE) Episodes Per Participant [ Time Frame: Baseline (Day 1) up to Week 14 ]
    A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported.
  • Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant [ Time Frame: Baseline (Day 1) up to Week 14 ]
    Median recurrence time was not to be calculated when less than 50% of the participants in a given arm experienced 1 or more HAEs.
  • Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14 [ Time Frame: Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up) ]
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2012)
  • Change from Baseline over 12-weeks in fasting plasma glucose [ Time Frame: up to 12 weeks ]
  • Proportion of Subjects acheiving HbA1C <6.5% and <7% at Week 12 [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin
Official Title  ICMJE A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety And Efficacy Of Pf-04937319 And Glimepiride In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Brief Summary This is a study to understand efficacy and safety of investigational agent (PF-04937319) compared to approved agent (glimepiride) in patients with diabetes on metformin
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Placebo
    Combination of tablets and capsules, a total of 3 pills/dose, administered once daily for 84-days
  • Drug: PF-04937319 10 mg
    Combination of tablets and capsules, dose of 10 mg, a total of 3 pills/dose, administered once daily for 84-days
  • Drug: PF-04937319 50 mg
    Combination of tablets and capsules, dose of 50 mg, a total of 3 pills/dose, administered once daily for 84-days
  • Drug: PF-04937319 100 mg
    Combination of tablets and capsules, dose of 100 mg, a total of 3 pills/dose, administered once daily for 84-days
  • Drug: Glimepiride
    Combination of tablets and capsules, dose of up to 6 mg, a total of 3 pills/dose, administered once daily for 84-days
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo to match PF-04937319 and glimepiride
    Intervention: Drug: Placebo
  • Experimental: PF-04937319 10 mg
    Intervention: Drug: PF-04937319 10 mg
  • Experimental: PF-04937319 50 mg
    Intervention: Drug: PF-04937319 50 mg
  • Experimental: PF-04937319 100 mg
    Intervention: Drug: PF-04937319 100 mg
  • Active Comparator: Glimepiride
    Intervention: Drug: Glimepiride
Publications * Amin NB, Aggarwal N, Pall D, Paragh G, Denney WS, Le V, Riggs M, Calle RA. Two dose-ranging studies with PF-04937319, a systemic partial activator of glucokinase, as add-on therapy to metformin in adults with type 2 diabetes. Diabetes Obes Metab. 2015 Aug;17(8):751-9. doi: 10.1111/dom.12474. Epub 2015 May 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2016)
304
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2012)
300
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent

Exclusion Criteria:

  • Subjects with recent cardiovascular events, those with evidence of diabetic complications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Canada,   Hungary,   India,   Slovakia,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01517373
Other Study ID Numbers  ICMJE B1621002
2011-005206-30 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP