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

March 26, 2010
May 6, 2015
May 2010
February 2011   (final data collection date for primary outcome measure)
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 ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01096667 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ] [ Designated as safety issue: No ]
  • Placebo-adjusted, change from baseline on average daytime, night time SBP using 24 hour ABPM [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Placebo-adjusted, change from baseline in trough SBP, DBP and pulse rate using automated device [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Placebo-adjusted, change from baseline on 24 hour urinary glucose excretion on Day 28 [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • Placebo adjusted, change from baseline in fasting plasma glucose [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Hypertension
  • 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: 5 mg Ertugliflozin
    pill, 5 mg, once daily for 28 days
  • Drug: 25 mg Ertugliflozin
    pill, 25 mg, once daily for 28 days
  • Drug: HCTZ 12.5mg
    capsule, 12.5 mg, once daily for 28 days
  • Drug: Placebo to HCTZ
    capsule, 12.5 mg, once daily for 28 days
  • Placebo Comparator: Placebo
    Placebo for Ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to HCTZ, once daily for 28 days.
    Interventions:
    • Drug: Placebo to Ertuglilflozin
    • Drug: Placebo to HCTZ
  • Experimental: Ertugliflozin 1 mg
    Ertugliflozin 1 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
    Interventions:
    • Drug: Placebo to Ertuglilflozin
    • Drug: 1 mg Ertugliflozin
    • Drug: Placebo to HCTZ
  • Experimental: Ertugliflozin 5 mg
    Ertugliflozin 5 mg, placebo to ertugliflozin (25 mg), and placebo to HCTZ, once daily for 28 days
    Interventions:
    • Drug: Placebo to Ertuglilflozin
    • Drug: 5 mg Ertugliflozin
    • Drug: Placebo to HCTZ
  • Experimental: Ertugliflozin 25 mg
    Ertugliflozin 25 mg, placebo to ertugliflozin (1 mg or 5 mg), and placebo to HCTZ, once daily for 28 days
    Interventions:
    • Drug: Placebo to Ertuglilflozin
    • Drug: 25 mg Ertugliflozin
    • Drug: Placebo to HCTZ
  • 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
    Interventions:
    • Drug: Placebo to Ertuglilflozin
    • Drug: HCTZ 12.5mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States,   India,   Malaysia,   Serbia,   Taiwan
 
NCT01096667
8835-042
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Merck Sharp & Dohme Corp.
May 2015

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