Trial · NCT01999218

Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)

NCT01999218, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2018-05-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002). Trials, record NCT01999218. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01999218

On this page

Trial

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

Title: Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)
NCT number: NCT01999218
Status: Completed
Phases: Phase 3
Enrollment: 1,326 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Type 2 Diabetes Mellitus
Interventions: Ertugliflozin 5 mg, Ertugliflozin 10 mg, Glimerpiride, Placebo to Ertugliflozin, Placebo to Glimepiride, Metformin, Sitagliptin
First posted: 2013-12-03
Last updated: 2019-04-02
Other registries' IDs: eudract:2013-003582-34
Results first posted: 2018-05-11

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach	Baseline and Week 52	A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. The primary study objective was the MK-8835 15 mg vs. glimepiride comparison; the MK-8835 5mg vs glimerpiride comparison was a secondary study objective.
Primary	Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106	Up to Week 106	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.
Primary	Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104	Up to Week 104	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.
Secondary	Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 52: Excluding Rescue Approach	Up to Week 52	Symptomatic hypoglycemia was an event with clinical symptoms reported by the investigator as hypoglycemia (biochemical documentation not required). Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.
Secondary	Change From Baseline in Body Weight at Week 52 Excluding Rescue Approach	Baseline and Week 52	This change from baseline reflects the Week 52 body weight minus the Week 0 body weight. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.
Secondary	Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 Excluding Rescue Approach	Baseline and Week 52	This change from baseline reflects the Week 52 SBP minus the Week 0 SBP. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.

Source ClinicalTrials.gov

Outcomes6

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 Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach	Baseline and Week 52	All randomized, treated participants with at least one A1C measurement (baseline or a post-baseline).	Percent	LEAST_SQUARES_MEAN
PRIMARY	Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106	Up to Week 106	All randomized participants who took at least one dose of trial treatment, 10 randomized participants from one trial site were excluded from these analyzes, and one randomized participant did not receive treatment.	Percentage of Participants	NUMBER
PRIMARY	Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104	Up to Week 104	All randomized participants who took at least one dose of trial treatment, 10 randomized participants from one trial site were excluded from these analyzes, and one randomized participant did not receive treatment.	Percentage of Participants	NUMBER
SECONDARY	Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 52: Excluding Rescue Approach	Up to Week 52	All randomized participants who took at least one dose of trial treatment.	Percentage of Participants	NUMBER
SECONDARY	Change From Baseline in Body Weight at Week 52 Excluding Rescue Approach	Baseline and Week 52	All randomized, treated participants with at least one body weight measurement (baseline or a post-baseline).	Kilograms	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 Excluding Rescue Approach	Baseline and Week 52	All randomized, treated participants with at least one SBP measurement (baseline or a post-baseline).	mmHg	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group18

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach	Ertugliflozin 5 mg	-0.56	95% Confidence Interval -0.65 to -0.47	Percent
Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach	Ertugliflozin 15 mg	-0.64	95% Confidence Interval -0.73 to -0.55	Percent
Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach	Glimepiride	-0.74	95% Confidence Interval -0.83 to -0.65	Percent
Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106	Ertugliflozin 5 mg	70.1		Percentage of Participants
Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106	Ertugliflozin 15 mg	71.3		Percentage of Participants
Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106	Glimepiride	69.7		Percentage of Participants
Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104	Ertugliflozin 5 mg	6.5		Percentage of Participants
Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104	Ertugliflozin 15 mg	8.0		Percentage of Participants
Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104	Glimepiride	5.1		Percentage of Participants
Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 52: Excluding Rescue Approach	Ertugliflozin 5 mg	3.1		Percentage of Participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ertugliflozin 5 mg	448
Overall Study	STARTED	Ertugliflozin 15 mg	441
Overall Study	STARTED	Glimepiride	437
Overall Study	Treated	Ertugliflozin 5 mg	448
Overall Study	Treated	Ertugliflozin 15 mg	440
Overall Study	Treated	Glimepiride	437
Overall Study	Site Issue	Ertugliflozin 5 mg	445
Overall Study	Site Issue	Ertugliflozin 15 mg	435
Overall Study	Site Issue	Glimepiride	435
Overall Study	COMPLETED	Ertugliflozin 5 mg	339

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events390

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	Diarrhoea	Gastrointestinal disorders	Ertugliflozin 5 mg	13	445	17
other	Diarrhoea	Gastrointestinal disorders	Ertugliflozin 15 mg	12	435	12
other	Diarrhoea	Gastrointestinal disorders	Glimepiride	22	435	24
other	Common cold	Infections and infestations	Ertugliflozin 5 mg	21	445	31
other	Common cold	Infections and infestations	Ertugliflozin 15 mg	17	435	29
other	Common cold	Infections and infestations	Glimepiride	23	435	31
other	Upper respiratory tract infection	Infections and infestations	Ertugliflozin 5 mg	27	445	39
other	Upper respiratory tract infection	Infections and infestations	Ertugliflozin 15 mg	14	435	19
other	Upper respiratory tract infection	Infections and infestations	Glimepiride	18	435	27
other	Urinary tract infection	Infections and infestations	Ertugliflozin 5 mg	27	445	30

1 to 10 of 390Source ClinicalTrials.gov

See all 390 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ertugliflozin 5 mg	7	445
Total, all-cause mortality	Ertugliflozin 15 mg	2	435
Total, all-cause mortality	Glimepiride	1	435
Total, other adverse events	Ertugliflozin 5 mg	110	445
Total, other adverse events	Ertugliflozin 15 mg	104	435
Total, other adverse events	Glimepiride	165	435
Total, serious adverse events	Ertugliflozin 5 mg	41	445
Total, serious adverse events	Ertugliflozin 15 mg	32	435
Total, serious adverse events	Glimepiride	30	435

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29282633	DERIVED	PubMed
30760125	RESULT	PubMed
31797522	DERIVED	PubMed
32236732	DERIVED	PubMed
32324065	DERIVED	PubMed
32324082	DERIVED	PubMed
32372382	DERIVED	PubMed
32648108	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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01999218

GET https://conductscience.org/api/trials/v1/NCT01999218/events?page=2

API reference For AI assistants