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Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01096667
First Posted: March 31, 2010
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
MK-8835-042 (B1521004) is designed to assess the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729), in participants with type 2 diabetes and hypertension. Participants in the study will receive 1 of 5 treatments for 1 month including 1 treatment with an approved drug - hydrochlorothiazide (HCTZ).

Condition Intervention Phase
Diabetes Mellitus, Type 2 Hypertension Drug: Placebo to Ertuglilflozin Drug: 1 mg Ertugliflozin Drug: 5 mg Ertugliflozin Drug: 25 mg Ertugliflozin Drug: HCTZ 12.5mg Drug: Placebo to HCTZ Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate The Safety, Tolerability And Efficacy Of Once Daily PF-04971729 And Hydrochlorothiazide In Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic And Blood Pressure Control

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from baseline on average, 24 hour systolic blood pressure (SBP) on Day 28 assessed using 24 hour ambulatory blood pressure monitoring (ABPM) [ Time Frame: Baseline and Day 28 ]

Secondary Outcome Measures:
  • Change from baseline on average, daytime, night time, and 24-hour diastolic blood pressure (DBP) on Day 28 using 24 hour ABPM [ Time Frame: Baseline and Day 28 ]
  • Change from baseline on average daytime, night time SBP on Day 28 using 24 hour ABPM [ Time Frame: Baseline and Day 28 ]
  • Change from baseline in trough SBP and DBP using automated device [ Time Frame: Baseline and Day 28 ]
  • Change from baseline on 24 hour urinary glucose excretion on Day 28 [ Time Frame: Baseline and Day 28 ]
  • Change from baseline in fasting plasma glucose on Day 28 [ Time Frame: Baseline and Day 28 ]
  • Change from baseline in trough pulse rate on Day 28 using automated device [ Time Frame: Baseline and Day 28 ]
  • Change from baseline on average, daytime, night time pulse rate on Day 28 using 24 hour ABPM [ Time Frame: Baseline and Day 28 ]
  • Number of participants who experienced and adverse event (AE) [ Time Frame: Up to 28 days postdose (Up to 56 days) ]
  • Number of participants who discontinued study drug due to an AE [ Time Frame: Up to 28 days ]

Enrollment: 195
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
Drug: Placebo to Ertuglilflozin
pill(s) (1 mg and/or 5 mg and/or 25 mg) once daily for 28 days
Drug: Placebo to HCTZ
capsule, 12.5 mg, once daily for 28 days
Experimental: Ertugliflozin 1 mg
Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
Drug: Placebo to Ertuglilflozin
pill(s) (1 mg and/or 5 mg and/or 25 mg) once daily for 28 days
Drug: 1 mg Ertugliflozin
pill, 1 mg, once daily for 28 days
Drug: Placebo to HCTZ
capsule, 12.5 mg, once daily for 28 days
Experimental: Ertugliflozin 5 mg
Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
Drug: Placebo to Ertuglilflozin
pill(s) (1 mg and/or 5 mg and/or 25 mg) once daily for 28 days
Drug: 5 mg Ertugliflozin
pill, 5 mg, once daily for 28 days
Drug: Placebo to HCTZ
capsule, 12.5 mg, once daily for 28 days
Experimental: Ertugliflozin 25 mg
Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
Drug: Placebo to Ertuglilflozin
pill(s) (1 mg and/or 5 mg and/or 25 mg) once daily for 28 days
Drug: 25 mg Ertugliflozin
pill, 25 mg, once daily for 28 days
Drug: Placebo to HCTZ
capsule, 12.5 mg, once daily for 28 days
Active Comparator: HCTZ 12.5mg
HCTZ 12.5 mg, placebo to ertugliflozin (1 mg or 5 mg and 25 mg), once daily for 28 days
Drug: Placebo to Ertuglilflozin
pill(s) (1 mg and/or 5 mg and/or 25 mg) once daily for 28 days
Drug: HCTZ 12.5mg
capsule, 12.5 mg, once daily for 28 days

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes and hypertension
  • Medically stable
  • On at least 1 (and up to 2) oral diabetes drugs
  • And up to 2 medicines for blood pressure control

Exclusion Criteria:

  • Patients with type 1 diabetes
  • Heart attack
  • Stroke
  • Uncontrolled blood pressure
  • Significant kidney disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096667


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Pfizer
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01096667     History of Changes
Other Study ID Numbers: 8835-042
First Submitted: March 26, 2010
First Posted: March 31, 2010
Last Update Posted: November 17, 2017
Last Verified: November 2016

Keywords provided by Merck Sharp & Dohme Corp.:
type 2 diabetes
hypertension
ambulatory blood pressure monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action