Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin

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.

Time frame: Baseline (Day 1), Week 12

Population: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.

Time frame: Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up)

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.

Time frame: Baseline (Day 1), Week 2, 4, 6, 8, 12

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.

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.

Time frame: Baseline (Day 1), Week 2, 4, 6, 8

Population: FAS: All randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was summarized for this measure and 'n' signifies participants who were evaluable at given time points for each group. Data for Week 2 had not been reported because as per protocol it was not intended to be collected.

A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported.

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

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

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).

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

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure

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.

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

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure

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).

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

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment. N(number of participants analyzed)= participants who were evaluable for this measure.

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.

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

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

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.

Time frame: Week 12

Population: FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure.

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.

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

Population: Safety analysis set included all randomized participants who received at least 1 dose of study treatment.

Median recurrence time was not to be calculated when less than 50% of the participants in a given arm experienced 1 or more HAEs.

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

Population: Data was not collected since this outcome measure was not analyzed due to infrequency of the occurrence of HAEs among the participants.