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

NCT01096667

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus, Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Participants 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Participants with type 1 diabetes


- Heart attack


- Stroke


- Uncontrolled blood pressure


- Significant kidney disease

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)
Official Title  ICMJE 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
Brief Summary 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 28 days (either placebo, 1 of 3 doses of ertugliflozin [1, 5, or 25 mg], or the approved drug hydrochlorothiazide [HCTZ]). The primary hypothesis of the study was that ertugliflozin was superior to placebo on the change from baseline in average, 24-hour systolic blood pressure (SBP) on Day 28.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Hypertension
Intervention  ICMJE
  • Drug: Placebo to Ertuglilflozin 1 or 5 mg
    Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days
  • Drug: Ertugliflozin 1 mg
    Ertugliflozin tablet 1 mg once daily for 28 days
  • Drug: Ertugliflozin 5 mg
    Ertugliflozin tablet 5 mg once daily for 28 days
  • Drug: Ertugliflozin 25 mg
    Ertugliflozin tablet 25 mg once daily for 28 days
  • Drug: HCTZ 12.5mg
    Hydrocholorthiazide (HCTZ) 12.5 mg capsule once daily for 28 days
  • Drug: Placebo to HCTZ
    Placebo to HCTZ 12.5 mg capsule once daily for 28 days
  • Drug: Placebo to ertuglilflozin 25 mg
    Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
Study Arms  ICMJE
  • Placebo Comparator: 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.
    Interventions:
    • Drug: Placebo to Ertuglilflozin 1 or 5 mg
    • Drug: Placebo to HCTZ
    • Drug: Placebo to ertuglilflozin 25 mg
  • Experimental: Ertugliflozin 1 mg
    Ertugliflozin 1 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days
    Interventions:
    • Drug: Ertugliflozin 1 mg
    • Drug: Placebo to HCTZ
    • Drug: Placebo to ertuglilflozin 25 mg
  • Experimental: Ertugliflozin 5 mg
    Ertugliflozin 5 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days
    Interventions:
    • Drug: Ertugliflozin 5 mg
    • Drug: Placebo to HCTZ
    • Drug: Placebo to ertuglilflozin 25 mg
  • Experimental: 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
    Interventions:
    • Drug: Placebo to Ertuglilflozin 1 or 5 mg
    • Drug: Ertugliflozin 25 mg
    • Drug: Placebo to HCTZ
  • Active Comparator: 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
    Interventions:
    • Drug: Placebo to Ertuglilflozin 1 or 5 mg
    • Drug: HCTZ 12.5mg
    • Drug: Placebo to ertuglilflozin 25 mg
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2017)
194
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2010)
175
Actual Study Completion Date  ICMJE February 25, 2011
Actual Primary Completion Date February 9, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants 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:

  • Participants with type 1 diabetes
  • Heart attack
  • Stroke
  • Uncontrolled blood pressure
  • Significant kidney disease
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries India,   Malaysia,   Puerto Rico,   Serbia,   Taiwan,   United States
 
Administrative Information
NCT Number  ICMJE NCT01096667
Other Study ID Numbers  ICMJE 8835-042
B1521004 ( Other Identifier: Pfizer protocol number )
MK-8835-042 ( Other Identifier: Merck Protocol Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialD…
URL:http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Medical DirectorMerck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP