NCT00989079 is a Phase 1 clinical trial of Ertugliflozin in Type 2 Diabetes Mellitus, sponsored by Merck Sharp & Dohme LLC.

Who is sponsoring NCT00989079?

NCT00989079 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT00989079?

Interventions in NCT00989079: Ertugliflozin, Placebo to Ertugliflozin.

What condition does NCT00989079 study?

NCT00989079 studies Type 2 Diabetes Mellitus.

Is NCT00989079 still recruiting?

NCT00989079 is currently completed. Last updated 29 May 2020.

Last reviewed 2020-05-29 · How we verify

NCT00989079

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Single Escalating Dose Study Of Ertugliflozin (PF-04971729, MK-8835) Under Fed and Fasted Conditons In Healthy Volunteers (MK-8835-036)

Completed Phase 1 Last updated 29 May 2020

What this trial tests

Phase 1 trial testing Ertugliflozin in Type 2 Diabetes Mellitus in 24 participants. Completed in 11 December 2009.

Timeline

16 October 2009

Primary endpoint
11 December 2009

11 December 2009

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	other
Enrollment	24
Start date	16 October 2009
Primary completion	11 December 2009
Estimated completion	11 December 2009

Drugs / interventions tested

Ertugliflozin (ERTUGLIFLOZIN) — full drug profile →
Placebo to Ertugliflozin — full drug profile →

Conditions studied

Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 55, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ertugliflozin (PF-04971729, MK-8835) is a new compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this study is to evaluate the safety and tolerability along with the pharmacokinetics of single escalating doses of ertugliflozin under fed and fasted conditions in healthy volunteers.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Overview of the Clinical Pharmacology of Ertugliflozin, a Novel Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor.
Fediuk DJ, Nucci G, Dawra VK, Cutler DL, et al · · 2020 · cited 39× · PMID 32337660 · DOI 10.1007/s40262-020-00875-1
Physiologically-Based Pharmacokinetic Modeling of the Drug-Drug Interaction of the UGT Substrate Ertugliflozin Following Co-Administration with the UGT Inhibitor Mefenamic Acid.
Callegari E, Lin J, Tse S, Goosen TC, et al · · 2021 · cited 18× · PMID 33314761 · DOI 10.1002/psp4.12581
Meta-Analysis of Noncompartmental Pharmacokinetic Parameters of Ertugliflozin to Evaluate Dose Proportionality and UGT1A9 Polymorphism Effect on Exposure.
Marshall JC, Liang Y, Sahasrabudhe V, Tensfeldt T, et al · · 2021 · cited 12× · PMID 33813736 · DOI 10.1002/jcph.1866
Population Pharmacokinetic Model for Ertugliflozin in Healthy Subjects and Patients With Type 2 Diabetes Mellitus.
Fediuk DJ, Zhou S, Dawra VK, Sahasrabudhe V, et al · · 2021 · cited 6× · PMID 33205593 · DOI 10.1002/cpdd.885
Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations.
Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, et al · · 2021 · PMID 34213819 · DOI 10.1002/cpdd.970

Verify or expand the search:

Other trials of Ertugliflozin

Trials testing the same drug.

NCT07547878 — Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) · Phase 4 · not yet recruiting
NCT04438213 — Ertugliflozin in Chronic Heart Failure · Phase 2 · recruiting
NCT04231331 — Ertugliflozin for Functional Mitral Regurgitation · Phase 3 · completed
NCT04167761 — Ertugliflozin: Cardioprotective Effects on Epicardial Fat · EARLY_PHASE1 · completed
NCT03717194 — Effect of Ertugliflozin on Cardiac Function in Diabetes · Phase 3 · completed

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00989079 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 29 May 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00989079.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing