Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01517373
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 304
- Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent
- Subjects with recent cardiovascular events, those with evidence of diabetic complications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-04937319 100 mg PF-04937319 100 mg - Placebo Placebo Placebo to match PF-04937319 and glimepiride PF-04937319 10 mg PF-04937319 10 mg - PF-04937319 50 mg PF-04937319 50 mg - Glimepiride Glimepiride -
- Primary Outcome Measures
Name Time Method Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8 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 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 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 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 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) 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 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 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 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 Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up) Number of Participants With Abnormal Laboratory Values 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).
Trial Locations
- Locations (53)
Sierra Clinical Research
🇺🇸Roseville, California, United States
California Research Foundation
🇺🇸San Diego, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Meridien Research
🇺🇸Bradenton, Florida, United States
South Broward Research, LLC
🇺🇸Pembroke Pines, Florida, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Clinical Research Center of Cape Cod, Inc.
🇺🇸Hyannis, Massachusetts, United States
Diabetes & Endocrinology Consultants, PC
🇺🇸Morehead City, North Carolina, United States
Sterling Research Group, Ltd.
🇺🇸Cincinnati, Ohio, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
Scroll for more (43 remaining)Sierra Clinical Research🇺🇸Roseville, California, United States