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Completed

NCT Number: NCT01096667

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo to Ertuglilflozin 1 or 5 mg

Drug

Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days

Ertugliflozin 1 mg

Drug

Ertugliflozin tablet 1 mg once daily for 28 days

Ertugliflozin 5 mg

Drug

Ertugliflozin tablet 5 mg once daily for 28 days

Ertugliflozin 25 mg

Drug

Ertugliflozin tablet 25 mg once daily for 28 days

HCTZ 12.5mg

Drug

Hydrocholorthiazide (HCTZ) 12.5 mg capsule once daily for 28 days

Placebo to HCTZ

Drug

Placebo to HCTZ 12.5 mg capsule once daily for 28 days

Placebo to ertuglilflozin 25 mg

Drug

Placebo to ertuglilflozin tablet 25 mg once daily for 28 days

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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).

  19. 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.

  20. Baseline Fasting Plasma Glucose (FPG)

    Time frame: Baseline

    For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).

  21. 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).

  22. 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).

  23. 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.

  24. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Pfizer

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2010
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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