A Study to Assess the Addition of Sitagliptin to Metformin Compared With the Addition of Dapagliflozin to Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) and Mild Renal Impairment Who Have Inadequate Glycemic Control on Metformin With or Without a Sulfonylurea (MK-0431-838)

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.

Time frame: Baseline and Week 24

Population: All randomized and treated participants who had at least one observation for the analysis endpoint, at baseline or subsequent to at least one dose of study treatment.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product. The AE does not have to have a causal relationship with this treatment. The AE can include any unfavourable and unintended sign, symptom, or disease or any worsening (change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the pharmaceutical product.

Time frame: Up to 24 weeks

Population: All randomized and treated participants.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product. The AE does not have to have a causal relationship with this treatment. The AE can include any unfavourable and unintended sign, symptom, or disease or any worsening (change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the pharmaceutical product.

Time frame: Up to 26 weeks

Population: All randomized and treated participants.

The 2hr PPG is the change from baseline in mean post prandial glucose (change from baseline PPG = Week 24 mean T-120 glucose minus Baseline mean T-120 glucose) and shows each drugs impact on PPG. The 2-point MMTT measured values at T-0 and T-120 while the 3-point MMTT measured values at T-0, T-60, and T-120: although only a subset of the study had the 3-point MMTT performed, all participants had a T-0 and T-120 time point. A negative (-) change from baseline to Week 24 indicates better control of postprandial glucose.

Time frame: Immediately before and 120 minutes after the standard meal at Baseline and Week 24

Population: All randomized and treated participants who underwent MMTT for the analysis endpoint, had both baseline and Week 24 endpoint measurements, without: drug compliance \<75%, use of prohibited AHA medications or pharmacologic doses of corticosteroids or incorrect double-blind study drug or a change in metformin or sulfonylurea dose.

Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at Week 0).

Time frame: Baseline and Week 24

Population: All randomized and treated participants who had at least one observation for the analysis endpoint, at baseline or subsequent to at least one dose of study treatment.

AUC endpoints were analyzed for participants who underwent the 3-point MMTT. Blood samples were drawn immediately prior to (T=0 minutes) and 60 and 120 minutes after the administration of the standard meal. The AUC curve was generated with the 3 time points. If any time point for a given participant was missing, the AUC was not included. Change in Postprandial Glucagon AUC after the morning meal (t=0 to 120 minutes) was calculated from the glucagon AUC over the first 120 minutes following the morning meal at baseline minus glucagon AUC over the first 120 minutes following the morning meal at Week 24. A negative (-) change from baseline to Week 24 indicates better control of postprandial glucose.

Time frame: Immediately before and 60 and 120 minutes after the standard meal at Baseline and Week 24

Population: All randomized and treated participants who underwent MMTT for the analysis endpoint, had both baseline and Week 24 endpoint measurements, without: drug compliance \<75%, use of prohibited AHA medications or pharmacologic doses of corticosteroids or incorrect double-blind study drug or a change in metformin or sulfonylurea dose.

The 2hr PPGE is the change from baseline in the mean incremental change in post meal glucose defined as T-120 minus T-0 for each participant: change from baseline PPGE = Week 24 mean (T-120 minus T-0) minus Baseline mean (T-120 minus T-0). The 2-point MMTT measured values at T-0 and T-120 while the 3-point MMTT measured values at T-0, T-60, and T-120: although only a subset of the study had the 3-point MMTT performed, all participants had a T-0 and T-120 time point. A negative (-) change from baseline to Week 24 indicates better control of postprandial glucose.

Time frame: Immediately before and 120 minutes after the standard meal at Baseline and Week 24

Population: All randomized and treated participants who underwent MMTT for the analysis endpoint, had both baseline and Week 24 endpoint measurements, without: drug compliance \<75%, use of prohibited AHA medications or pharmacologic doses of corticosteroids or incorrect double-blind study drug or a change in metformin or sulfonylurea dose.

AUC endpoints were analyzed for participants who underwent the 3-point MMTT. Blood samples were drawn immediately prior to (T=0 minutes) and 60 and 120 minutes after the administration of the standard meal. The AUC curve was generated with the 3 time points. If any time point for a given participant was missing, the AUC was not included. Change in Postprandial Insulin AUC after the morning meal (t=0 to 120 minutes) was calculated from insulin AUC over the first 120 minutes following the morning meal at baseline minus insulin AUC over the first 120 minutes following the morning meal at Week 24. A negative (-) change from baseline to Week 24 indicates better control of postprandial glucose.

Time frame: Immediately before and 60 and 120 minutes after the standard meal at Baseline and Week 24

Population: All randomized and treated participants who underwent MMTT for the analysis endpoint, had both baseline and Week 24 endpoint measurements, without: drug compliance \<75%, use of prohibited AHA medications or pharmacologic doses of corticosteroids or incorrect double-blind study drug or a change in metformin or sulfonylurea dose.

AUC endpoints were analyzed for participants who underwent the 3-point MMTT. Blood samples were drawn immediately prior to (T=0 minutes) and 60 and 120 minutes after the administration of the standard meal. The AUC curve was generated with the 3 time points. If any time point for a given participant was missing, the AUC was not included. The endpoint was calculated from the ratio of (insulin AUC / glucagon AUC) over the first 120 minutes following the morning meal at baseline minus AUC over the first 120 minutes following the morning meal at Week 24. A negative (-) change from baseline to Week 24 indicates better control of postprandial glucose.

Time frame: Immediately before and 60 and 120 minutes after the standard meal at Baseline and Week 24

Population: All randomized and treated participants who underwent MMTT for the analysis endpoint, had both baseline and Week 24 endpoint measurements, without: drug compliance \<75%, use of prohibited AHA medications or pharmacologic doses of corticosteroids or incorrect double-blind study drug or a change in metformin or sulfonylurea dose.

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.

Time frame: Week 24

Population: All randomized and treated participants who had at least one observation for the analysis endpoint, at baseline or subsequent to at least one dose of study treatment.