| Primary | Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14 | Plasma glucose concentration was determined predose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours postdose on Days 0 (baseline) and 14. WMDG was calculated as the area under the curve (AUC) of the 12-point plasma glucose concentration-time profile divided by 24 hours. | Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement at both baseline and on Day 14. | Posted | | Least Squares Mean | Standard Error | milligram/deciliter (mg/dL) | | Prior to morning dose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours post morning dose on Days 0 (baseline) and Day 14 | | | | ID | Title | Description |
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| OG000 | PF-04937319 Split-Dose (150+100 mg) | Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG001 | PF-04937319 Once-Daily (300 mg) | Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG002 | Sitagliptin 100 mg | Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-31.24± 3.952(NA to NA)
- OG001-31.33± 4.604(NA to NA)
- OG002-19.24± 4.437(NA to NA)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | Mean Difference (Final Values) | -31.24 | | | 2-Sided | 80 | -36.35 | -26.12 | | | | No | Superiority or Other | | | | | | |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14 | Blood samples for measurement of glucose to permit derivation of pre-meal collections at the pre-specified nominal timepoints of each period: predose (ie, time "0"), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours on Day 0 (baseline) and Day 14; and predose on Days 1 and 15. | Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement on Day 14. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Day 14 | | | | ID | Title | Description |
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| OG000 | PF-04937319 Split-Dose (150+100 mg) | Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG001 | PF-04937319 Once-Daily (300 mg) | Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. |
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| Secondary | Change From Baseline in Pre-meal C-Peptide on Day 14 | Blood samples for measurement of glucose to permit derivation of pre-meal collections of blood samples for C-peptide at the pre-specified nominal timepoints at predose, 5 and 11 hours on Day 0 (baseline) and Day 14. | Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement on Day 14. | Posted | | Least Squares Mean | Standard Error | nanograms/milliliter (ng/mL) | | Day 14 | | | | ID | Title | Description |
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| OG000 | PF-04937319 Split-Dose (150+100 mg) | Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG001 | PF-04937319 Once-Daily (300 mg) | Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. |
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| Secondary | Change From Baseline in Pre-meal Insulin on Day 14 | Blood samples for measurement of glucose to permit derivation of pre-meal collections of blood samples for insulin at 0, 5 and 11 hours on Day 0 (baseline) and Day 14. | Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement on Day 14. | Posted | | Least Squares Mean | Standard Error | micro international unit/milliliter | | Day 14 | | | | ID | Title | Description |
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| OG000 | PF-04937319 Split-Dose (150+100 mg) | Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG001 | PF-04937319 Once-Daily (300 mg) | Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. |
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| Secondary | Incidence of All Causality Treatment-Emergent Adverse Event by Preferred Term (Frequency Rate >5%) | | The safety analysis set was all participants who received at least one dose of randomized study treatment. HAEs meeting protocol definition were summarized descriptively by treatment. | Posted | | Number | | participants | | Day 1 up to Day 14 | | | | ID | Title | Description |
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| OG000 | Metformin Run-in | Participants were instructed to take the morning dose of the study medication and at least 1 dose of open label metformin at the same time of day with the morning meal each day. | | OG001 | PF-04937319 Split-Dose (150+100 mg) | Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG002 | PF-04937319 Once-Daily (300 mg) | Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. |
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| Secondary | Frequency of Laboratory Test Abnormalities Reported in Any Treatment Group | The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. | The safety analysis set was all participants who received at least one dose of randomized study treatment. | Posted | | Number | | participants | | Day 1 up to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 Split-Dose (150+100 mg) | Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG001 | PF-04937319 Once-Daily (300 mg) | Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG002 | Sitagliptin 100 mg | |
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| Secondary | Change From Baseline in Body Weight (kg) | | The safety analysis set was all participants who received at least one dose of randomized study treatment. | Posted | | Mean | Standard Error | kg | | Day 1 up to Day 14 | | | | ID | Title | Description |
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| OG000 | PF-04937319 Split-Dose (150+100 mg) | Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG001 | PF-04937319 Once-Daily (300 mg) | Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG002 | Sitagliptin 100 mg | Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. |
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| Secondary | Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern | Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: sitting systolic BP (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, sitting SBP =<20 mmHg change from baseline, supine/sitting/standing SBP less than (<) 90 mm Hg; sitting diastolic BP (DBP) >=20 mm Hg change from baseline, sitting SBP =<20 mmHg change from baseline, supine/sitting/standing DBP <50 mm Hg; 2), pulse rate (supine): <40 or greater than (>) 120 beats per minute (bpm). | The safety analysis set was all participants who received at least one dose of randomized study treatment. | Posted | | Number | | participants | | Day 1 up to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 Split-Dose (150+100 mg) | Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG001 | PF-04937319 Once-Daily (300 mg) | Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. |
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| Secondary | Number of Participants With Post-baseline Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern | ECG criteria of potential clinical concern were 1), PR interval: >=300 milliseconds (msec); >=25% increase when baseline >200 msec; or increase >=50% when baseline <=200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), QTc interval using Fridericia's formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >500 msec; absolute change 30 - <60, >=60 msec. | The safety analysis set was all participants who received at least one dose of randomized study treatment. | Posted | | Number | | participants | | Day 1 up to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 Split-Dose (150+100 mg) | Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG001 | PF-04937319 Once-Daily (300 mg) | Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. |
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| Secondary | Plasma PF-04937319 Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC24) of PF-04937319 at Day 14 | The PK parameters were summarized descriptively by treatment as appropriate. Two (2) PK parameters specified in the protocol and SAP were not reported: AUClast was not reported since it was the same as AUC24 in this study, and apparent volume of distribution (Vz/F) was not reported since the log-linear terminal phase of the concentration-time profiles was not consistently well characterized in the 24-hour sampling period. | The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng•hr/mL | | Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15. | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 Split-Dose (150+100 mg) | Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG001 | PF-04937319 Once-Daily (300 mg) | Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. |
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| Secondary | Plasma PF-04937319 Apparent Clearance (CL/F) on Day 14 | The PK parameters were summarized descriptively by treatment as appropriate. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/min | | Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15. | | | | ID | Title | Description |
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| OG000 | PF-04937319 Split-Dose (150+100 mg) | Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG001 | PF-04937319 Once-Daily (300 mg) | Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. |
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| Secondary | Plasma PF-04937319 Average Concentration Over the 24-hour Period (Cav) on Day 14 | Cav was average concentration over the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate. | The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15. | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 Split-Dose (150+100 mg) | Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG001 | PF-04937319 Once-Daily (300 mg) | Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. |
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| Secondary | Plasma PF-04937319 Highest Observed Concentration (Cmax) on Day 14 | Cmax was highest observed concentration. The PK parameters were summarized descriptively by treatment as appropriate. | The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15. | | | | ID | Title | Description |
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| OG000 | PF-04937319 Split-Dose (150+100 mg) | Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG001 | PF-04937319 Once-Daily (300 mg) | Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. |
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| Secondary | Plasma PF-04937319 Lowest Observed Concentration During the 24-hour Period (Cmin) on Day 14 | Cmin lowest observed concentration during the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate. | The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15. | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 Split-Dose (150+100 mg) | Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG001 | PF-04937319 Once-Daily (300 mg) | Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. |
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| Secondary | Plasma PF-04937319 Time for Cmax (Tmax) on Day 14 | Tmax was time of maximum concentration. The PK parameters were summarized descriptively by treatment as appropriate. | The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration. | Posted | | Median | Full Range | hour | | Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15. | | | | ID | Title | Description |
|---|
| OG000 | PF-04937319 Split-Dose (150+100 mg) | Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. | | OG001 | PF-04937319 Once-Daily (300 mg) | Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days. |
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