Trial Outcomes & Findings for 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) (NCT NCT02532855)

Last Updated: 2018-11-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

614 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2018-11-20

Participant Flow

This study was conducted at 183 medical centers in 24 countries.

Male and female participants, 25 years or older, with Type 2 diabetes mellitus (T2DM) and mild renal impairment on metformin alone or in combination with a sulfonylurea (SU) agent were enrolled in this trial.

Participant milestones

Participant milestones
Measure	Sitagliptin Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.	Dapagliflozin Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
Overall Study STARTED	307	307
Overall Study Treated	307	306
Overall Study COMPLETED	299	296
Overall Study NOT COMPLETED	8	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Sitagliptin Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.	Dapagliflozin Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
Overall Study Lost to Follow-up	4	3
Overall Study Withdrawal by Subject	4	8

Baseline Characteristics

All randomized and treated participants

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sitagliptin n=307 Participants Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.	Dapagliflozin n=306 Participants Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
Change From Baseline in A1C at Week 24	-0.51 Percent A1C Interval -0.6 to -0.43	-0.36 Percent A1C Interval -0.45 to -0.27

PRIMARY outcome

Timeframe: Up to 26 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.

Outcome measures

Outcome measures
Measure	Sitagliptin n=307 Participants Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.	Dapagliflozin n=306 Participants Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
Percentage of Participants Who Experienced One or More Adverse Events	48.9 Percentage of participants	51.6 Percentage of participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: All randomized and treated participants.

Outcome measures

Outcome measures
Measure	Sitagliptin n=307 Participants Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.	Dapagliflozin n=306 Participants Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
Percentage of Participants Who Discontinued Study Drug Due to an AE	3.3 Percentage of participants	3.3 Percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sitagliptin n=298 Participants Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.	Dapagliflozin n=296 Participants Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
Change From Baseline in Incremental 2-hour (2-hr) Postprandial Glucose Excursion (PPGE) at Week 24	-24.2 mg/dL Interval -30.4 to -18.0	-18.5 mg/dL Interval -24.9 to -12.1

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Sitagliptin n=258 Participants Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.	Dapagliflozin n=248 Participants Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
Change From Baseline in 2-hr Postprandial Glucose (PPG) at Week 24	-40.4 mg/dL Interval -46.9 to -33.9	-37.0 mg/dL Interval -43.7 to -30.3

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Sitagliptin n=85 Participants Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.	Dapagliflozin n=88 Participants Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
Change From Baseline in Glucagon Area Under the Curve (AUC0-120 Minutes) at Week 24	-4.2 pmol.hr/L Interval -8.8 to 0.4	0.2 pmol.hr/L Interval -4.4 to 4.8

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Sitagliptin n=96 Participants Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.	Dapagliflozin n=94 Participants Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
Change From Baseline in Insulin AUC0-120 Minutes at Week 24	-23.4 mIU.hr/L Interval -36.8 to -9.9	-28.2 mIU.hr/L Interval -42.1 to -14.4

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Sitagliptin n=83 Participants Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.	Dapagliflozin n=81 Participants Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
Change From Baseline in Postprandial Insulin AUC0-120 Minutes to Glucagon AUC0-120 Minutes Ratio at Week 24	-0.6 Ratio Interval -1.1 to 0.0	-1.2 Ratio Interval -1.8 to -0.7

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sitagliptin n=307 Participants Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.	Dapagliflozin n=306 Participants Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
Percentage of Participants With A1C <7% (53 mmol/Mol) at Week 24	42.6 Percentage of Participants	27.0 Percentage of Participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Sitagliptin n=307 Participants Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.	Dapagliflozin n=306 Participants Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	-16.5 mg/dL Interval -20.6 to -12.5	-20.1 mg/dL Interval -24.3 to -15.9

Adverse Events

Dapagliflozin

Serious events: 13 serious events

Other events: 21 other events

Deaths: 0 deaths

Sitagliptin

Serious events: 10 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Dapagliflozin n=306 participants at risk Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.	Sitagliptin n=307 participants at risk Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.
Metabolism and nutrition disorders Hypoglycaemia	6.9% 21/306 • Number of events 64 • Up to 26 weeks An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not have to have a causal relationship. 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. The population analyzed included all randomized and treated participants.	7.2% 22/307 • Number of events 51 • Up to 26 weeks An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not have to have a causal relationship. 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. The population analyzed included all randomized and treated participants.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Sitagliptin n=307 Participants Participants receive sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 5 mg once daily for 4 weeks followed by sitagliptin 100 mg once daily plus matching placebo for dapagliflozin 10 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.	Dapagliflozin n=306 Participants Participants receive dapagliflozin 5 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 4 weeks followed by dapagliflozin 10 mg once daily plus matching placebo for sitagliptin 100 mg once daily for 20 weeks. Participants continue pre-study metformin (at least 1500 mg daily) alone or in combination with a sulfonylurea agent (at a dose of ≥ 50% maximum labeled dose in the country of the investigational site) throughout the duration of the study.	Total n=613 Participants Total of all reporting groups
Age, Continuous	67.7 Years STANDARD_DEVIATION 8.5 • n=307 Participants • All randomized and treated participants	66.6 Years STANDARD_DEVIATION 8.6 • n=306 Participants • All randomized and treated participants	67.1 Years STANDARD_DEVIATION 8.5 • n=613 Participants • All randomized and treated participants
Sex: Female, Male Female	138 Participants n=307 Participants • All randomized and treated participants	120 Participants n=306 Participants • All randomized and treated participants	258 Participants n=613 Participants • All randomized and treated participants
Sex: Female, Male Male	169 Participants n=307 Participants • All randomized and treated participants	186 Participants n=306 Participants • All randomized and treated participants	355 Participants n=613 Participants • All randomized and treated participants
Race (NIH/OMB) American Indian or Alaska Native	18 Participants n=307 Participants • All randomized and treated participants	14 Participants n=306 Participants • All randomized and treated participants	32 Participants n=613 Participants • All randomized and treated participants
Race (NIH/OMB) Asian	11 Participants n=307 Participants • All randomized and treated participants	7 Participants n=306 Participants • All randomized and treated participants	18 Participants n=613 Participants • All randomized and treated participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=307 Participants • All randomized and treated participants	1 Participants n=306 Participants • All randomized and treated participants	1 Participants n=613 Participants • All randomized and treated participants
Race (NIH/OMB) Black or African American	8 Participants n=307 Participants • All randomized and treated participants	11 Participants n=306 Participants • All randomized and treated participants	19 Participants n=613 Participants • All randomized and treated participants
Race (NIH/OMB) White	240 Participants n=307 Participants • All randomized and treated participants	234 Participants n=306 Participants • All randomized and treated participants	474 Participants n=613 Participants • All randomized and treated participants
Race (NIH/OMB) More than one race	30 Participants n=307 Participants • All randomized and treated participants	39 Participants n=306 Participants • All randomized and treated participants	69 Participants n=613 Participants • All randomized and treated participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=307 Participants • All randomized and treated participants	0 Participants n=306 Participants • All randomized and treated participants	0 Participants n=613 Participants • All randomized and treated participants
Hemoglobin A1C	7.7 Percent A1C STANDARD_DEVIATION 0.7 • n=307 Participants • All randomized and treated participants	7.8 Percent A1C STANDARD_DEVIATION 0.7 • n=306 Participants • All randomized and treated participants	7.7 Percent A1C STANDARD_DEVIATION 0.7 • n=613 Participants • All randomized and treated participants
Fasting Plasma Glucose (FPG)	162.3 mg/dL STANDARD_DEVIATION 40.4 • n=307 Participants • All randomized and treated participants	165.2 mg/dL STANDARD_DEVIATION 40.6 • n=306 Participants • All randomized and treated participants	163.8 mg/dL STANDARD_DEVIATION 40.5 • n=613 Participants • All randomized and treated participants
Background Antihyperglycemic Agent (AHA) Metformin Alone	212 Participants n=307 Participants • All randomized and treated participants	225 Participants n=306 Participants • All randomized and treated participants	437 Participants n=613 Participants • All randomized and treated participants
Background Antihyperglycemic Agent (AHA) Metformin and Sulfonylurea	95 Participants n=307 Participants • All randomized and treated participants	81 Participants n=306 Participants • All randomized and treated participants	176 Participants n=613 Participants • All randomized and treated participants
Incremental 2-hour Postprandial Glucose Excursion (PPGE)	96.2 mg/dL STANDARD_DEVIATION 55.3 • n=295 Participants • All randomized and treated participants who underwent MMTT analysis and had a baseline measurement for this endpoint.	95.7 mg/dL STANDARD_DEVIATION 47.1 • n=290 Participants • All randomized and treated participants who underwent MMTT analysis and had a baseline measurement for this endpoint.	95.9 mg/dL STANDARD_DEVIATION 51.4 • n=585 Participants • All randomized and treated participants who underwent MMTT analysis and had a baseline measurement for this endpoint.
2-hr Postprandial Glucose	257.7 mg/dL STANDARD_DEVIATION 67.1 • n=296 Participants • All randomized and treated participants who underwent MMTT analysis and had a baseline measurement for this endpoint.	259.9 mg/dL STANDARD_DEVIATION 64.4 • n=292 Participants • All randomized and treated participants who underwent MMTT analysis and had a baseline measurement for this endpoint.	258.8 mg/dL STANDARD_DEVIATION 65.7 • n=588 Participants • All randomized and treated participants who underwent MMTT analysis and had a baseline measurement for this endpoint.
Glucagon Area Under the Curve (AUC0-120 minutes)	49.6 pmol.hr/L STANDARD_DEVIATION 44.7 • n=108 Participants • All randomized and treated participants who underwent MMTT analysis and had a baseline measurement for this endpoint.	51.8 pmol.hr/L STANDARD_DEVIATION 45.1 • n=109 Participants • All randomized and treated participants who underwent MMTT analysis and had a baseline measurement for this endpoint.	50.7 pmol.hr/L STANDARD_DEVIATION 44.8 • n=217 Participants • All randomized and treated participants who underwent MMTT analysis and had a baseline measurement for this endpoint.
Insulin AUC0-120 minutes	155.0 mIU.hr/L STANDARD_DEVIATION 121.8 • n=113 Participants • All randomized and treated participants who underwent MMTT analysis and had a baseline measurement for this endpoint.	139.9 mIU.hr/L STANDARD_DEVIATION 93.5 • n=112 Participants • All randomized and treated participants who underwent MMTT analysis and had a baseline measurement for this endpoint.	147.5 mIU.hr/L STANDARD_DEVIATION 108.7 • n=225 Participants • All randomized and treated participants who underwent MMTT analysis and had a baseline measurement for this endpoint.
Insulin AUC0-120 minutes to Glucagon AUC0-120 minutes Ratio	4.0 Ratio STANDARD_DEVIATION 3.7 • n=104 Participants • All randomized and treated participants who underwent MMTT analysis and had a baseline measurement for this endpoint.	3.5 Ratio STANDARD_DEVIATION 3.0 • n=102 Participants • All randomized and treated participants who underwent MMTT analysis and had a baseline measurement for this endpoint.	3.8 Ratio STANDARD_DEVIATION 3.4 • n=206 Participants • All randomized and treated participants who underwent MMTT analysis and had a baseline measurement for this endpoint.