MK-8835/PF-04971729 vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01999218
First received: November 25, 2013
Last updated: July 17, 2014
Last verified: July 2014

November 25, 2013
July 17, 2014
December 2013
December 2015   (final data collection date for primary outcome measure)
  • Change from Baseline in Hemoglobin A1C at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Number of Participants Experiencing An Adverse Event (AE) [ Time Frame: Up to Week 106 ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Study Treatment Due to an AE [ Time Frame: Up to Week 104 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01999218 on ClinicalTrials.gov Archive Site
  • Number of Participants with an Adverse Event of Symptomatic Hypoglycemia [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Body Weight at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Change from Baseline in Systolic Blood Pressure at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
MK-8835/PF-04971729 vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)
A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Ertugliflozin (MK-8835/PF-04971729) Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

This study will evaluate the efficacy and safety of the addition of ertugliflozin (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who have inadequate glycemic control on metformin. The duration of the trial will be up to approximately 122 weeks. This will include a 1-week screening period, an up to 13-week wash-off/titration/dose stabilization period, a 2-week placebo run-in period, a 104-week double-blind, active comparator-controlled treatment period, and a post-treatment telephone contact 14 days after the last dose of study drug. The primary hypothesis of this study is that after 52 weeks, the change from baseline in hemoglobin A1C in participants treated with the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in participants treated with the addition of glimepiride.

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
    Oral, once daily, from Day 1 to Week 104
    Other Name: MK-8835
  • Drug: Glimepiride
    Oral tablets, initiated at 1 mg daily and titrated up to the maximum approved dose (6 or 8 mg daily based on the local country label) or maximum tolerated dose
  • Drug: Placebo to Ertugliflozin
    Matching placebo to Ertugliflozin, oral, once daily, from Day 1 to Week 104
  • Drug: Placebo to Glimepiride
    Matching placebo to Glimepiride, 0ral, once daily, from Day 1 to Week 104
  • Drug: Metformin
    The dose of metformin (≥1500 mg/day) should remain stable throughout the 104-week double-blind treatment period.
  • Drug: Sitagliptin
    Open label, oral, once daily, rescue medication as required
  • Experimental: Ertugliflozin 5 mg
    Oral, once daily, from Day 1 to Week 104
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Placebo to Ertugliflozin
    • Drug: Placebo to Glimepiride
    • Drug: Metformin
    • Drug: Sitagliptin
  • Experimental: Ertugliflozin 15 mg
    Oral, once daily, from Day 1 to Week 104
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Placebo to Glimepiride
    • Drug: Metformin
    • Drug: Sitagliptin
  • Active Comparator: Glimepiride up to 8 mg
    Oral, once daily from Day 1 to Week 104
    Interventions:
    • Drug: Glimepiride
    • Drug: Placebo to Ertugliflozin
    • Drug: Metformin
    • Drug: Sitagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1230
December 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of T2DM in accordance to American Diabetes Association guidelines
  • On metformin monotherapy or metformin in combination with a single allowable anti-hyperglycemic agent (AHA), dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, or alpha-glucosidase inhibitors) prior to study participation.
  • Body Mass Index (BMI) ≥18.0 kg/m^2
  • Male or female not of reproductive potential
  • If a female of reproductive potential, agree to remain abstinent or to use (or have their partner use) 2 acceptable combinations of birth control while participating in the trial and for 14 days after the last use of study drug.

Exclusion Criteria:

  • History or presence of type 1 diabetes mellitus or a history of ketoacidosis
  • History of other specific types of diabetes (eg, genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
  • A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) inhibitor
  • Use of the following prohibited therapeutic agents within 12 weeks of study participation: insulin, injectable anti-hyperglycemic agents, pioglitazone or rosiglitazone, another SGLT2 inhibitor, bromocriptine (Cycloset®), colesevelam (Welchol®), and any other non-approved anti-hyperglycemic therapy
  • Known hypersensitivity or intolerance to metformin or glimepiride
  • On a weight-loss program or medication or medication associated with weight changes and is not weight-stable (>=5% change in body weight in the last 6 months)
  • History of bariatric surgery less than 12 months prior to study participation
  • 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
  • Active, obstructive uropathy or an indwelling urinary catheter
  • 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
  • Known history of Human Immunodeficiency Virus (HIV)
  • Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
  • A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease
  • Any clinically significant malabsorption condition
  • Being treated for hyperthyroidism, or on thyroid replacement therapy that has not been at a stable dose for at least 6 weeks prior to study participation
  • Previous randomization in a study with ertugliflozin
  • Participation in other studies involving investigational drug(s) within 30 days of study participation and/or during the pre-randomization period
  • A surgical procedure within 6 weeks prior to study participation or planned major surgery during the trial
  • A positive urine pregnancy test
  • Pregnant or breast-feeding, or expecting to conceive during the trial, including 14 days following the last dose of study drug
  • Undergoing hormonal therapy in preparation to donate eggs during the period of the trial, including 14 days following the last dose of study drug
  • Consumption of more than 2 alcoholic drinks per day or engages in binge drinking
  • 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
Both
18 Years and older
No
Contact: Toll Free Number 1-888-577-8839
United States,   Canada,   Hungary,   Korea, Republic of
 
NCT01999218
8835-002, 2013-003582-34
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
July 2014

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