Trial · NCT02099110

Ertugliflozin and Sitagliptin Co-administration Factorial Study (VERTIS FACTORAL, MK-8835-005)

NCT02099110, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2017-11-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ertugliflozin and Sitagliptin Co-administration Factorial Study (VERTIS FACTORAL, MK-8835-005). Trials, record NCT02099110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02099110

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Ertugliflozin and Sitagliptin Co-administration Factorial Study (VERTIS FACTORAL, MK-8835-005)
NCT number: NCT02099110
Status: Completed
Phases: Phase 3
Enrollment: 1,233 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Type 2 Diabetes Mellitus
Interventions: Matching Placebo to Ertugliflozin 5 mg, Matching Placebo to Ertugliflozin 10 mg, Matching Placebo to sitagliptin 100 mg, Ertugliflozin 5 mg, Ertugliflozin 10 mg, Sitagliptin 100 mg, Metformin >= 1500 mg/day, Insulin Glargine Rescue Medication, Glimepiride Rescue Medication
First posted: 2014-03-28
Last updated: 2018-09-12
Other registries' IDs: eudract:2013-003698-82
Results first posted: 2017-11-01

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in A1C at Week 26: Excluding Rescue Approach	Baseline and Week 26	A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Primary	Percentage of Participants Who Experienced an Adverse Event (AE): Including Rescue Approach	Up to 54 weeks	An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy.
Primary	Percentage of Participants Who Discontinued Study Treatment Due to an AE: Including Rescue Approach	Up to 52 weeks	An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy.
Secondary	Change From Baseline in Body Weight at Week 26: Excluding Rescue Approach	Baseline and Week 26	This change from baseline reflects the Week 26 body weight minus the Week 0 body weight. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Excluding Rescue Approach	Baseline and Week 26	Blood glucose was measured on a fasting basis after at least a 10-hour fast. This change from baseline reflects the Week 26 FPG minus the Week 0 FPG. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Secondary	Percentage of Participants Achieving a Hemoglobin A1C of <7% (<53 mmol/Mol) (Raw Proportions): Excluding Rescue Approach	Week 26	A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Secondary	Change From Baseline in Static Beta-Cell Sensitivity to Glucose Index at Week 26; Excluding Rescue Approach	30 min. before and 0, 15, 30, 60, 90, 120, and 180 minutes following the start of the standard meal at Baseline and Week 26	Static beta-cell sensitivity to glucose index (SBCSGI) estimates the ratio of insulin secretion (expressed in pmol/min) related to above-basal glucose concentration (expressed in mmol/L \* L) following a meal. Blood samples were collected before and after a standard meal and glucose, insulin, and C-peptide levels were analyzed. The C-peptides minimal model was used to estimate the insulin secretion rate (ISR). Analysis included both non-model-based \[including insulinogenic index with C-peptide, glucose area under the curve (AUC)/insulin AUC\] and model-based \[beta cell function and insulin secretion rate at 9 mM glucose\] testing. Analysis was performed with non-linear least squares using the Software Architecture Analysis Method (SAAM) II software. SBCSGI was expressed in units of 10\^-9 min\^-1. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Secondary	Change From Baseline in Sitting Systolic Blood Pressure at Week 26: Excluding Rescue Approach	Baseline and Week 26	This change from baseline reflects the Week 26 systolic blood pressure minus the Week 0 systolic blood pressure. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in A1C at Week 26: Excluding Rescue Approach	Baseline and Week 26	The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the A1C change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.	Percentage	LEAST_SQUARES_MEAN
PRIMARY	Percentage of Participants Who Experienced an Adverse Event (AE): Including Rescue Approach	Up to 54 weeks	The analysis population consists of all randomized participants who received at least 1 dose of study treatment.	Percentage of participants	NUMBER
PRIMARY	Percentage of Participants Who Discontinued Study Treatment Due to an AE: Including Rescue Approach	Up to 52 weeks	The analysis population consists of all randomized participants who received at least 1 dose of study treatment.	Percentage of participants	NUMBER
SECONDARY	Change From Baseline in Body Weight at Week 26: Excluding Rescue Approach	Baseline and Week 26	The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the body weight change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.	Kilograms	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Excluding Rescue Approach	Baseline and Week 26	The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the FPG change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants Achieving a Hemoglobin A1C of <7% (<53 mmol/Mol) (Raw Proportions): Excluding Rescue Approach	Week 26	The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a post-randomization measurement for the A1C change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.	Percentage of participants	NUMBER
SECONDARY	Change From Baseline in Static Beta-Cell Sensitivity to Glucose Index at Week 26; Excluding Rescue Approach	30 min. before and 0, 15, 30, 60, 90, 120, and 180 minutes following the start of the standard meal at Baseline and Week 26	The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the beta-cell responsivity static component change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.	SBCSGI (10^-9min^-1)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Sitting Systolic Blood Pressure at Week 26: Excluding Rescue Approach	Baseline and Week 26	The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the systolic blood pressure change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.	mm Hg	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in A1C at Week 26: Excluding Rescue Approach	Ertugliflozin 5 mg	-1.02	95% Confidence Interval -1.14 to -0.90	Percentage
Change From Baseline in A1C at Week 26: Excluding Rescue Approach	Ertugliflozin 15 mg	-1.08	95% Confidence Interval -1.20 to -0.96	Percentage
Change From Baseline in A1C at Week 26: Excluding Rescue Approach	Sitagliptin 100 mg	-1.05	95% Confidence Interval -1.17 to -0.93	Percentage
Change From Baseline in A1C at Week 26: Excluding Rescue Approach	Ertugliflozin 5 mg + Sitagliptin 100 mg	-1.49	95% Confidence Interval -1.61 to -1.36	Percentage
Change From Baseline in A1C at Week 26: Excluding Rescue Approach	Ertugliflozin 15 mg + Sitagliptin 100 mg	-1.52	95% Confidence Interval -1.64 to -1.40	Percentage
Percentage of Participants Who Experienced an Adverse Event (AE): Including Rescue Approach	Ertugliflozin 5 mg	62.0		Percentage of participants
Percentage of Participants Who Experienced an Adverse Event (AE): Including Rescue Approach	Ertugliflozin 15 mg	57.7		Percentage of participants
Percentage of Participants Who Experienced an Adverse Event (AE): Including Rescue Approach	Sitagliptin 100 mg	57.5		Percentage of participants
Percentage of Participants Who Experienced an Adverse Event (AE): Including Rescue Approach	Ertugliflozin 5 mg + Sitagliptin 100 mg	58.8		Percentage of participants
Percentage of Participants Who Experienced an Adverse Event (AE): Including Rescue Approach	Ertugliflozin 15 mg + Sitagliptin 100 mg	55.7		Percentage of participants

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ertugliflozin 5 mg	250
Overall Study	STARTED	Ertugliflozin 15 mg	248
Overall Study	STARTED	Sitagliptin 100 mg	247
Overall Study	STARTED	Ertugliflozin 5 mg + Sitagliptin 100 mg	243
Overall Study	STARTED	Ertugliflozin 15 mg + Sitagliptin 100 mg	245
Overall Study	Treated	Ertugliflozin 5 mg	250
Overall Study	Treated	Ertugliflozin 15 mg	248
Overall Study	Treated	Sitagliptin 100 mg	247
Overall Study	Treated	Ertugliflozin 5 mg + Sitagliptin 100 mg	243
Overall Study	Treated	Ertugliflozin 15 mg + Sitagliptin 100 mg	244

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events275

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypoglycaemia	Metabolism and nutrition disorders	Ertugliflozin 5 mg	12	250	25
other	Hypoglycaemia	Metabolism and nutrition disorders	Ertugliflozin 15 mg	13	248	29
other	Hypoglycaemia	Metabolism and nutrition disorders	Sitagliptin 100 mg	11	247	22
other	Hypoglycaemia	Metabolism and nutrition disorders	Ertugliflozin 5 mg + Sitagliptin 100 mg	9	243	17
other	Hypoglycaemia	Metabolism and nutrition disorders	Ertugliflozin 15 mg + Sitagliptin 100 mg	20	244	42
other	Nasopharyngitis	Infections and infestations	Ertugliflozin 5 mg	6	250	6
other	Nasopharyngitis	Infections and infestations	Ertugliflozin 15 mg	13	248	14
other	Nasopharyngitis	Infections and infestations	Sitagliptin 100 mg	6	247	7
other	Nasopharyngitis	Infections and infestations	Ertugliflozin 5 mg + Sitagliptin 100 mg	12	243	14
other	Nasopharyngitis	Infections and infestations	Ertugliflozin 15 mg + Sitagliptin 100 mg	12	244	13

1 to 10 of 275Source ClinicalTrials.gov

See all 275 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ertugliflozin 5 mg
Total, all-cause mortality	Ertugliflozin 15 mg
Total, all-cause mortality	Sitagliptin 100 mg
Total, all-cause mortality	Ertugliflozin 5 mg + Sitagliptin 100 mg
Total, all-cause mortality	Ertugliflozin 15 mg + Sitagliptin 100 mg
Total, other adverse events	Ertugliflozin 5 mg	36	250
Total, other adverse events	Ertugliflozin 15 mg	43	248
Total, other adverse events	Sitagliptin 100 mg	28	247
Total, other adverse events	Ertugliflozin 5 mg + Sitagliptin 100 mg	31	243
Total, other adverse events	Ertugliflozin 15 mg + Sitagliptin 100 mg	38	244

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29266675	RESULT	PubMed
31797522	DERIVED	PubMed
32324065	DERIVED	PubMed
32324082	DERIVED	PubMed
32372382	DERIVED	PubMed
32648108	DERIVED	PubMed
32700393	DERIVED	PubMed
34213819	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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