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:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01096667
First received: March 26, 2010
Last updated: May 6, 2015
Last verified: May 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Change from baseline on average daytime, night time SBP on Day 28 using 24 hour ABPM [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
  • Change from baseline in trough SBP and DBP using automated device [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
  • Change from baseline on 24 hour urinary glucose excretion on Day 28 [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose on Day 28 [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
  • Change from baseline in trough pulse rate on Day 28 using automated device [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
  • Change from baseline on average, daytime, night time pulse rate on Day 28 using 24 hour ABPM [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
  • Number of participants who experienced and adverse event (AE) [ Time Frame: Up to 28 days postdose (Up to 56 days) ] [ Designated as safety issue: Yes ]
  • Number of participants who discontinued study drug due to an AE [ Time Frame: Up to 28 days ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096667

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01096667     History of Changes
Other Study ID Numbers: 8835-042
Study First Received: March 26, 2010
Last Updated: May 6, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 27, 2015