A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01958671
First received: October 7, 2013
Last updated: September 26, 2014
Last verified: September 2014

October 7, 2013
September 26, 2014
October 2013
August 2015   (final data collection date for primary outcome measure)
  • Change from Baseline In Hemoglobin A1c (HbA1c) at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
  • Number of Participants Experiencing An Adverse Event (AE) [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Study Treatment Due to an AE [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01958671 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Fasting Plasma Glucose (FPG) at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
  • Change from Baseline in Body Weight at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
  • Number of Participants with a HbA1c <7% (53 mmol/mol) at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Change from Baseline in 2-hour Post-prandial Plasma Glucose at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
  • Change from Baseline in Systolic Blood Pressure at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
  • Change from Baseline in Diastolic Blood Pressure at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003)
A Phase 3, Randomized, Double-blind, Placebo-controlled, 26-week Multicenter Study With a 26-Week Extension to Evaluate the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise

This trial will evaluate the efficacy and safety of ertugliflozin monotherapy in the treatment of subjects with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on diet and exercise. This trial consists of a run-in period of 3 to 11 weeks, a 26-week placebo-controlled treatment period (Phase A), and a 26-week active treatment period (Phase B). The primary hypothesis of the trial is that at Week 26, the mean reduction from baseline in hemoglobin A1c (HbA1c) for 15 mg ertugliflozin is greater than that for placebo.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Ertugliflozin (5 mg)
    One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).
    Other Names:
    • MK-8835
    • PF-04971729
  • Drug: Ertugliflozin (10 mg)
    One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).
    Other Names:
    • MK-8835
    • PF-04971729
  • Drug: Placebo to Ertuglifozin
    One placebo tablet matching the ertugliflozin 5 mg tablet and/or 1 placebo tablet matching the ertugliflozin 10 mg tablet per day taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).
  • Drug: Metformin
    500 mg (1 tablet) in the morning and 500 mg (1 tablet) in the evening for 2 weeks, 1000 mg (2 tablets 500 mg) in the morning and 500 mg (1 tablet) in the evening ) for 2 weeks and 1000 mg (2 tablets 500 mg ) in the morning and 1000 mg (2 tablets 500 mg) in the evening thereafter.
  • Drug: Placebo to Metformin
    Placebo matching metformin.
    Other Name: Glucophage XR, Carbophage SR, Riomet, Fortamet, Glumetza, Obimet, Gluformin, Dianben, Diabex, Diaformin, Siofor and Metfogamma.
  • Experimental: Ertugliflozin (5 mg)
    Once daily for a 26-week placebo-controlled treatment period of Phase A and for a 26-week active-controlled treatment period (Phase B). In Phase B, participants not rescued with open label metformin in Phase A, will also receive placebo to metformin. Participants rescued with metformin in Phase A will enter into Phase B and continue to receive open-label metformin in addition to their original randomized treatment.
    Interventions:
    • Drug: Ertugliflozin (5 mg)
    • Drug: Placebo to Ertuglifozin
    • Drug: Placebo to Metformin
  • Experimental: Ertugliflozin (15 mg)
    Once daily for a 26-week placebo-controlled treatment period of Phase A and for a 26-week active-controlled treatment period (Phase B). In Phase B, participants not rescued with open label metformin in Phase A, will also receive placebo to metformin. Participants rescued with metformin in Phase A will enter into Phase B and continue to receive open-label metformin in addition to their original randomized treatment.
    Interventions:
    • Drug: Ertugliflozin (5 mg)
    • Drug: Ertugliflozin (10 mg)
    • Drug: Placebo to Metformin
  • Placebo Comparator: Placebo
    Once daily for a 26-week placebo-controlled treatment period of Phase A. In Phase B, participants not rescued with open-labeled metformin in Phase A will also receive blinded metformin in addition to placebo. Participants rescued with metformin in Phase A will enter into Phase B and continue to receive open-label metformin in addition to their original randomized treatment.
    Interventions:
    • Drug: Placebo to Ertuglifozin
    • Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
March 2016
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of T2DM in accordance to American Diabetes Association guidelines
  • Participants with no prior allowable oral anti-hyperglycemic agents (AHA) for at least 8 weeks prior to study participation or participants on a single allowable oral AHA at the start of study participation
  • Particpants on a single allowable AHA must be willing to discontinue this medication at the Screening Visit (S2) and remain off this medication for the duration of the trial. Allowable oral AHAs for discontinuation are metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, glinides or alpha-glucosidase inhibitors.

Exclusion Criteria:

  • History of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional class III-IV heart failure within 3 months of study participation
  • A clinically significant electrocardiogram abnormality
  • A history of malignancy ≤5 years prior to study participation, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer
  • A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) inhibitor or metformin
  • On a blood pressure or lipid altering medication that have not been on a stable dose for at least 4 weeks prior to study participation
  • A surgical procedure within 4 weeks prior to study participation or planned major surgery during the trial
  • Donation of blood or blood products within 6 weeks of study participation or plans to donate blood or blood products at any time during the trial
  • Pregnant or breast-feeding, or is expecting to conceive during the trial, including 14 days following the last dose of study drug
Both
18 Years and older
No
Contact: Toll Free Number 1-888-577-8839
United States,   Canada,   Italy,   South Africa,   United Kingdom
 
NCT01958671
8835-003, 2013-002519-90, B1521022
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Pfizer
Not Provided
Merck Sharp & Dohme Corp.
September 2014

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