Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)
NCT01999218
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
- 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), DPP-4 inhibitors, meglitinides and AGIs are listed as allowable AHAs along with sulfonylureas 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.
- 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
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002) | ||||||
| Official Title ICMJE | 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 | ||||||
| Brief Summary | 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 primary hypothesis of this study is that after 52 weeks, the change from baseline in hemoglobin A1c (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. | ||||||
| Detailed Description | 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. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | ||||||
| Condition ICMJE | Type 2 Diabetes Mellitus | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* 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 | 1326 | ||||||
| Original Estimated Enrollment ICMJE | 1230 | ||||||
| Actual Study Completion Date ICMJE | April 18, 2017 | ||||||
| Actual Primary Completion Date | April 18, 2017 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (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 | Argentina, Canada, Czech Republic, Hungary, Korea, Republic of, Lithuania, Mexico, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Taiwan, United States | ||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT01999218 | ||||||
| Other Study ID Numbers ICMJE | 8835-002 2013-003582-34 ( EudraCT Number ) B1521013 ( Other Identifier: Pfizer ) | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE |
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| Responsible Party | Merck Sharp & Dohme Corp. | ||||||
| Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||||||
| Collaborators ICMJE | Pfizer | ||||||
| Investigators ICMJE |
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| PRS Account | Merck Sharp & Dohme Corp. | ||||||
| Verification Date | March 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||