Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
NCT04029480
ABOUT THIS STUDY
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1. Has diabetes diagnosed by one of the American Diabetes Association (ADA) criteria.
2. Has body mass index (BMI) ≥85th percentile at screening OR participant has a history of being overweight or obese at time of diagnosis of Type 2 diabetes mellitus (T2DM).
3. T2DM for ≥2 years, OR T2DM for <2 years and a fasting C-peptide value >0.6 ng/mL at Screening.
4. On stable metformin monotherapy (≥1500 mg/day, for ≥8 weeks prior to Screening, OR on a stable metformin dose (≥1500 mg/day, for ≥8 weeks prior to Screening and a stable dose of insulin for ≥8 weeks prior to Screening.
5. Contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
6. Is a non-sterilized female who is currently not sexually active OR who agrees to abstain from heterosexual activity OR who agrees to start contraception prior to initiating sexual activity and who agrees to use an adequate method of contraception. Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
7. Have a family member or adult who, along with the participant, will be closely involved in the participant's daily activities (in the opinion of the investigator) and in the participant's treatment and study procedures.
1. Has known type 1 diabetes mellitus or documented evidence of positive diabetes
autoantibodies performed when participant was diagnosed with diabetes.
2. Has known monogenic diabetes, or secondary diabetes.
3. Has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate
initiation of another antihyperglycemic agent, including insulin.
4. Has a known hypersensitivity or intolerance to any sodium glucose co-transporter 2
(SGLT2) inhibitor.
5. Is pregnant, or breast feeding or is expecting to conceive or donate eggs during the
study, including 14 days following the last dose of study medication.
6. Has previously taken an SGLT2 inhibitor (such as canagliflozin, dapagliflozin,
empagliflozin, or ertugliflozin) or was enrolled in a study for these agents.
7. Has a history of idiopathic acute pancreatitis or chronic pancreatitis.
8. Has a history of severe hypoglycemia while on insulin.
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Descriptive Information | |||||||
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Brief Title ICMJE | Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059) | ||||||
Official Title ICMJE | A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in Pediatric Participants (Ages 10 to 17 Years, Inclusive) With Type 2 Diabetes Mellitus | ||||||
Brief Summary | This study will evaluate the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without insulin. The primary hypothesis of the study is that the addition of ertugliflozin reduces hemoglobin A1C (HbA1C) more than the addition of placebo after 24 weeks of treatment. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential 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 * | Not Provided | ||||||
* 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 | Recruiting | ||||||
Estimated Enrollment ICMJE | 150 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | July 10, 2025 | ||||||
Estimated Primary Completion Date | July 10, 2025 (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 | 10 Years to 17 Years (Child) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Belgium, Canada, Colombia, Costa Rica, Dominican Republic, France, Guatemala, Hungary, Israel, Italy, Malaysia, Mauritius, Mexico, Philippines, Poland, Russian Federation, Saudi Arabia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04029480 | ||||||
Other Study ID Numbers ICMJE | 8835-059 MK-8859-059 ( Other Identifier: Merck Protocol Number ) PHRR190913-002184 ( Registry Identifier: PHRR ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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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 | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |