Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)
NCT02226003
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Type 2 diabetes mellitus as per American Diabetes Association guidelines
- Not on antihyperglycemic agent (AHA) >=8 weeks with a Visit 1/Screening HbA1C >=8.0% and <=10.5% (>=64 mmol/mol and <=91 mmol/mol) OR on single allowable AHA (allowable AHAs prior to screening are: metformin, α-glucosidase inhibitors, sulfonylureas and glinides) with a Visit 1/Screening HbA1C >=7.5% and <=10.0% (>=58 mmol/mol and <=86 mmol/mol) OR on low-dose dual combination therapy (≤50% of maximum labeled dose of an AHA) with allowable AHAs with a Visit 1/Screening HbA1C >=7.5% and <=10.0% (>=58 mmol/mol and <=86 mmol/mol)
- Body mass index (BMI) >=18.0 kg/m^2
- Male or female not of reproductive potential
- Female of reproductive potential who agrees to (or have their partner agree to) remain abstinent from heterosexual activity or to use 2 acceptable combinations of contraception.
- History of type 1 diabetes mellitus or diabetic ketoacidosis
- History of other specific types of diabetes (e.g., 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 (SGLT2)
inhibitor or sitagliptin
- Has been treated with any of the following agents within 12 weeks of study start or
during the pre-randomization period: insulin of any type (except for short-term use
[i.e., <=7 days] during concomitant illness or other stress), other injectable
anti-hyperglycemic agents (e.g., pramlintide, exenatide, liraglutide), pioglitazone or
rosiglitazone, other sodium glucose co-transporter 2 (SGLT2) inhibitors,
dipeptidyl-peptidase 4 inhibitors (DPP-4 inhibitors), bromocriptine (Cycloset™),
colesevelam (Welchol™), any other AHA with the exception of the protocol-approved
agents
- Is on a weight-loss program or weight-loss medication or other medication associated
with weight changes and is not weight stable prior to study start
- Has undergone bariatric surgery within the past 12 months or >12 months and is not
weight stable prior to study start
- A 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 start
- Active, obstructive uropathy or indwelling urinary catheter
- History of malignancy <=5 years prior to study start, except for adequately treated
basal cell or squamous cell skin cancer or in situ cervical cancer
- A known history of human immunodeficiency virus (HIV)
- A blood dyscrasia or any disorder causing hemolysis or unstable red blood cells, or a
clinically important hematological disorder (e.g. aplastic anemia, myeloproliferative
or myelodysplastic syndromes, thrombocytopenia)
- A medical history of active liver disease (other than non-alcoholic hepatic
steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or
symptomatic gallbladder disease
- Any clinically significant malabsorption condition
- Current treatment for hyperthyroidism
- On thyroid replacement therapy and not on a stable dose for at least 6 weeks prior
study start
- On a previous clinical study with ertugliflozin
- Participated in other studies involving investigational drug(s) 30 days prior to study
start
- Surgical procedure within 6 weeks prior to study start or major surgery planned during
the trial
- Positive urine pregnancy test
- Pregnant or breast-feeding, or planning to conceive during the trial, including 14
days following the last dose of study medication
- Planning to undergo hormonal therapy in preparation for egg donation during the trial,
including 14 days following the last dose of study medication
- Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week or
engages in binge drinking
- Donated blood or blood products within 6 weeks of study start.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Hachioji, Tokyo
Descriptive Information | |||||||
---|---|---|---|---|---|---|---|
Brief Title ICMJE | Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017) | ||||||
Official Title ICMJE | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Initial Combination of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Subjects With T2DM With Inadequate Glycemic Control on Diet and Exercise | ||||||
Brief Summary | This is a study to evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in combination with sitagliptin in the treatment of participants with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control on diet and exercise. The primary hypothesis of the study is that ertugliflozin plus sitagliptin is more effective in lowering of hemoglobin A1C (HbA1C) than placebo. | ||||||
Detailed Description | Each participant will be in the study for approximately 39 weeks including: a 1-week screening period, an 8-week (or greater) antihyperglycemic agent (AHA) wash-off period, a 2-week single-blind placebo run-in period, a 26-week double-blind 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 |
| ||||||
Study Arms ICMJE |
| ||||||
Publications * |
| ||||||
* 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 | 291 | ||||||
Original Estimated Enrollment ICMJE | 300 | ||||||
Actual Study Completion Date ICMJE | February 23, 2016 | ||||||
Actual Primary Completion Date | February 23, 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
Sex/Gender ICMJE |
| ||||||
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 | Bulgaria, Czech Republic, Estonia, Hungary, Israel, Ukraine, United Kingdom, United States | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02226003 | ||||||
Other Study ID Numbers ICMJE | 8835-017 2014-001049-25 ( EudraCT Number ) B1521047 ( Other Identifier: Pfizer Protocol Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
| ||||||
Responsible Party | Merck Sharp & Dohme Corp. | ||||||
Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||||||
Collaborators ICMJE | Pfizer | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Merck Sharp & Dohme Corp. | ||||||
Verification Date | August 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |