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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)

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ClinicalTrials.gov Identifier: NCT01096667
Recruitment Status : Completed
First Posted : March 31, 2010
Results First Posted : December 13, 2017
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE March 26, 2010
First Posted Date  ICMJE March 31, 2010
Results First Submitted Date  ICMJE November 15, 2017
Results First Posted Date  ICMJE December 13, 2017
Last Update Posted Date September 13, 2018
Actual Study Start Date  ICMJE May 17, 2010
Actual Primary Completion Date February 9, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
  • Baseline 24-hour Average Systolic Blood Pressure (SBP) [ Time Frame: 24 hours ]
    Baseline 24-hour average SBP was assessed using 24-hour ambulatory blood pressure monitoring (ABPM).
  • Change From Baseline on 24-hour Average SBP at Week 4 [ Time Frame: Baseline and Week 4 ]
    Change from baseline on 24-hour average SBP at Week 4 assessed using 24-hour ABPM. In the case of missing data, last observation carried forward (LOCF).
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
Placebo-adjusted, 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: 28 Days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2017)
  • Baseline Average Daytime and Nighttime SBP [ Time Frame: Daytime: 16 hours; Nighttime: 8 hours ]
    Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.
  • Change From Baseline on Daytime Average SBP at Week 4 [ Time Frame: Baseline and Week 4 ]
    Change from baseline on daytime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.
  • Change From Baseline on Nighttime Average SBP at Week 4 [ Time Frame: Baseline and Week 4 ]
    Change from baseline on nighttime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.
  • Baseline Seated, Triplicate Trough SBP [ Time Frame: Baseline ]
    Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough SBP is calculated as the mean of triplicate (3) trough SBP measures.
  • Change From Baseline in Seated, Triplicate Trough SBP at Week 4 [ Time Frame: Baseline and Week 4 ]
    Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.
  • Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP) [ Time Frame: up to 24 hours ]
    Baseline 24-hour average DBP was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.
  • Change From Baseline on 24-hour Average DBP at Week 4 [ Time Frame: Baseline and Week 4 ]
    Change from baseline on 24-hour average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF.
  • Change From Baseline on Daytime Average DBP at Week 4 [ Time Frame: Baseline and Week 4 ]
    Change from baseline on daytime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.
  • Change From Baseline on Nighttime Average DBP at Week 4 [ Time Frame: Baseline and Week 4 ]
    Change from baseline on nighttime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.
  • Baseline Seated, Triplicate Trough DBP [ Time Frame: Baseline ]
    Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough DBP is calculated as the mean of triplicate (3) trough DBP measures.
  • Change From Baseline in Seated, Triplicate Trough DBP at Week 4 [ Time Frame: Baseline and Week 4 ]
    Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.
  • Baseline 24-hour, Daytime and Nightime Average Heart Rate [ Time Frame: up to 24 hours ]
    Baseline 24-hour average heart rate was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.
  • Change From Baseline on 24-hour Average Heart Rate at Week 4 [ Time Frame: Baseline and Week 4 ]
    Change from baseline in 24-hour average heart rate at Week 4 using 24 hour ABPM.
  • Change From Baseline on Daytime Average Heart Rate at Week 4 [ Time Frame: Baseline and Week 4 ]
    Change from baseline in daytime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.
  • Change From Baseline on Nighttime Average Heart Rate at Week 4 [ Time Frame: Baseline and Week 4 ]
    Change from baseline in 24-hour nighttime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.
  • Baseline Seated, Triplicate Trough Heart Rate [ Time Frame: Baseline ]
    Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. Baseline trough heart rate is calculated as the mean of triplicate (3) trough heart rate measures.
  • Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4 [ Time Frame: Baseline and Week 4 ]
    Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.
  • Baseline 24-hour Average Urinary Glucose Excretion [ Time Frame: 24 hours ]
    Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as >20 hours and <28 hours).
  • Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4 [ Time Frame: Baseline and Week 4 ]
    Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as >20 hours and <28 hours). In the case of missing data, LOCF.
  • Baseline Fasting Plasma Glucose (FPG) [ Time Frame: Baseline ]
    For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).
  • Change From Baseline in FPG at Week 4 [ Time Frame: Baseline and Week 4 ]
    For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).
  • Change From Baseline in FPG at Week 2 [ Time Frame: Baseline and Week 2 ]
    For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).
  • Number of Participants Who Experienced an Adverse Event (AE) [ Time Frame: Up to 63 days (including run-in, treatment period, and follow-up) ]
    An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug.
  • Number of Participants Who Discontinued Study Drug Due to an AE [ Time Frame: Up to 28 days (treatment period) ]
    An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug. Discontinuation of study drug due to an AE includes temporary and permanent discontinuation of study drug due to an AE.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
  • Placebo-adjusted, change from baseline on average, daytime, night time and 24-hour diastolic blood pressure (DBP), and pulse rate on Day 28 using 24 hour ABPM [ Time Frame: 28 Days ]
  • Placebo-adjusted, change from baseline on average daytime, night time SBP using 24 hour ABPM [ Time Frame: 28 Days ]
  • Placebo-adjusted, change from baseline in trough SBP, DBP and pulse rate using automated device [ Time Frame: 28 Days ]
  • Placebo-adjusted, change from baseline on 24 hour urinary glucose excretion on Day 28 [ Time Frame: 28 Days ]
  • Placebo adjusted, change from baseline in fasting plasma glucose [ Time Frame: 28 Days ]
  • Placebo-adjusted, change from baseline on average, daytime, night time and 24 hour SBP, DBP, pulse rate on Day 28 using 24 hour ABPM [ Time Frame: 28 Days ]
  • Assessment of clinical safety-related laboratory tests, 12 lead electrocardiograms (ECG), adverse events/serious adverse events including urinary tract and genital fungal infections, hypo- and hyper- glycemia as well as hypo- and hyper tension [ Time Frame: 28 Days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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/ProcedureAccessClinicalTrialData.pdf
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 Director Merck 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