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

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ClinicalTrials.gov Identifier: NCT01475461
Recruitment Status : Completed
First Posted : November 21, 2011
Results First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Placebo Drug: PF-04937319 - 3mg Drug: PF-04937319 - 20mg Drug: PF-04937319 - 50mg Drug: PF-04937319 - 100mg Drug: Sitagliptin - 100mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Sitagliptin

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
double-dummy placebo tablets administered once-daily for 84-days
Experimental: PF-04937319 - Dose 1 Drug: PF-04937319 - 3mg
PF-04937319 3mg administered as tablets once-daily for 84-days
Experimental: PF-04937319 - Dose 2 Drug: PF-04937319 - 20mg
PF-04937319 20mg administered as tablets once-daily for 84-days
Experimental: PF-04937319 - Dose 3 Drug: PF-04937319 - 50mg
PF-04937319 50mg administered as tablets once-daily for 84-days
Experimental: PF-04937319 - Dose 4 Drug: PF-04937319 - 100mg
PF-04937319 100mg administered as tablets once-daily for 84-days
Active Comparator: Sitagliptin Drug: Sitagliptin - 100mg
Sitagliptin 100mg administered as tablets once-daily for 84-days


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475461


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01475461    
Other Study ID Numbers: B1621007
2011-004002-25 ( EudraCT Number )
First Posted: November 21, 2011    Key Record Dates
Results First Posted: January 31, 2017
Last Update Posted: January 31, 2017
Last Verified: December 2016
Keywords provided by Pfizer:
Phase 2
type 2 diabetes mellitus
PF-04937319
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
 Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action