Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)
NCT ID: NCT01096667
Last Updated: 2018-09-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
194 participants
INTERVENTIONAL
2010-05-17
2011-02-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of the Efficacy and Safety of Ertugliflozin in Participants With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Antihyperglycemic Therapy (MK-8835-001)
NCT01986855
Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014)
NCT02115347
Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)
NCT01948986
Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure
NCT04071626
Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004)
NCT01986881
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo to ertugliflozin (resembling either 1 mg or 5 mg), placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days.
Placebo to Ertuglilflozin 1 or 5 mg
Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days
Placebo to HCTZ
Placebo to HCTZ 12.5 mg capsule once daily for 28 days
Placebo to ertuglilflozin 25 mg
Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
Ertugliflozin 1 mg
Ertugliflozin 1 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days
Ertugliflozin 1 mg
Ertugliflozin tablet 1 mg once daily for 28 days
Placebo to HCTZ
Placebo to HCTZ 12.5 mg capsule once daily for 28 days
Placebo to ertuglilflozin 25 mg
Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
Ertugliflozin 5 mg
Ertugliflozin 5 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days
Ertugliflozin 5 mg
Ertugliflozin tablet 5 mg once daily for 28 days
Placebo to HCTZ
Placebo to HCTZ 12.5 mg capsule once daily for 28 days
Placebo to ertuglilflozin 25 mg
Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
Ertugliflozin 25 mg
Ertugliflozin 25 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to HCTZ once daily for 28 days
Placebo to Ertuglilflozin 1 or 5 mg
Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days
Ertugliflozin 25 mg
Ertugliflozin tablet 25 mg once daily for 28 days
Placebo to HCTZ
Placebo to HCTZ 12.5 mg capsule once daily for 28 days
HCTZ 12.5mg
HCTZ 12.5 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to ertugliflozin (resembling 25 mg) once daily for 28 days
Placebo to Ertuglilflozin 1 or 5 mg
Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days
HCTZ 12.5mg
Hydrocholorthiazide (HCTZ) 12.5 mg capsule once daily for 28 days
Placebo to ertuglilflozin 25 mg
Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo to Ertuglilflozin 1 or 5 mg
Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days
Ertugliflozin 1 mg
Ertugliflozin tablet 1 mg once daily for 28 days
Ertugliflozin 5 mg
Ertugliflozin tablet 5 mg once daily for 28 days
Ertugliflozin 25 mg
Ertugliflozin tablet 25 mg once daily for 28 days
HCTZ 12.5mg
Hydrocholorthiazide (HCTZ) 12.5 mg capsule once daily for 28 days
Placebo to HCTZ
Placebo to HCTZ 12.5 mg capsule once daily for 28 days
Placebo to ertuglilflozin 25 mg
Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Medically stable
* On at least 1 (and up to 2) oral diabetes drugs
* And up to 2 medicines for blood pressure control
Exclusion Criteria
* Heart attack
* Stroke
* Uncontrolled blood pressure
* Significant kidney disease
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
Explore related publications, articles, or registry entries linked to this study.
Amin NB, Wang X, Mitchell JR, Lee DS, Nucci G, Rusnak JM. Blood pressure-lowering effect of the sodium glucose co-transporter-2 inhibitor ertugliflozin, assessed via ambulatory blood pressure monitoring in patients with type 2 diabetes and hypertension. Diabetes Obes Metab. 2015 Aug;17(8):805-8. doi: 10.1111/dom.12486. Epub 2015 Jun 17.
Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, Sweeney K. Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1297-1306. doi: 10.1002/cpdd.970. Epub 2021 Jul 2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B1521004
Identifier Type: OTHER
Identifier Source: secondary_id
MK-8835-042
Identifier Type: OTHER
Identifier Source: secondary_id
8835-042
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.