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Submitted by: Reina Kristine Marie Boter 2019-08-15 03:41:51 Last Updated by: Reina Kristine Marie Boter 2020-09-14 07:28:10


Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK8835/PF-04971729) (MK-8835-059)

PHRR190913-002184

MK-8835-059

2019-CT0505

A Phase 3, Multicenter, Double-blind Randomized, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of Ertugliflozin (MK8835/PF-04971729) in Pediatric Participants (ages 10 to 17 years, inclusive) with Type 2 Diabetes Meullitus

This study will evaluate the safety and efficacy of ertugliflozin (MK8835) in pediatric participants with T2DM on metformin with/without insulin. The primary hypothesis of the study is the addition of ertugliflozin reduces hemoglobin A1C (HbA1C) more than the addition of placebo afer 24weeks of treatment

Regime Classification Priority
2017 - 2022 Global competitiveness and innovation in health Drug discovery and development
Start Date Duration in Months Target Completion Date Actual Completion Date
2020-09-30 72 2026-09-30 0000-00-00

Ongoing

Institution Classification Region LTO #
MERCK SHARP & DOHME (I.A.) LLC Private Business NCR CDRR-NCR-S-16
Institution Region
Merck Sharp & Dohme (I.A.) LLC NCR
Name E-Mail Institution and Institution Address
Priscila Perez priscila.d.perez@merck.com 26/F Philamlife Tower Paseo De Roxas Makati City 1226
Name E-Mail Institution and Institution Address
Priscila Perez priscila.d.perez@merck.com 26/F Philamlife Tower Paseo De Roxas Makati City 1226
Name Expertise Affiliation
Aretha Ann Liwag, MD Principal Investigator West Visayas State University Medical Center
Grace P. Aquitania, MD Principal Investigator Davao Doctors Hospital
Jeimeen J. Agra, MD Principal Investigator UERMMMC Institute for Studies on Diabetes Foundation Inc.
Project Location Institutional Ethics Review Board
West Visayas State University Medical Center N/A
Davao Doctors Hospital Davao Doctors Hospital Ethics Review Committee
UERMMMC Institute for Studies on Diabetes Foundation Inc. UERMMMC Institute for Studies on Diabetes Foundation Inc. Ethics Review Board

Type 2 Diabetes Mellitus

Change from Baseline in Hemoglobin A1C (HbA1C) at 24 weeks [ Time Frame: Baseline and 24 weeks ]
Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples are collected at baseline and Week 24 to determine the least squares mean HbA1C change from baseline (i.e., HbA1C at Week 24 minus HbA1C at baseline).

Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to 24 weeks ]
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.

Number of Participants Who Experience an AE [ Time Frame: Up to 54 weeks ]
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to 24 weeks ]
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to 54 weeks ]
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.

 

Change from Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks [ Time Frame: Baseline and 24 weeks ]
Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).
Change from Baseline in Hemoglobin A1C at 54 Weeks [ Time Frame: Baseline and 54 weeks ]
Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples are collected at baseline and Week 54 to determine the least squares mean HbA1C change from baseline (i.e., HbA1C at Week 54 minus HbA1C at baseline).
Change from Baseline in FPG at 54 Weeks [ Time Frame: Baseline and 54 weeks ]
Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).

Pending

  • Belgium
  • Canada
  • Colombia
  • Costa Rica
  • Dominican Republic
  • France
  • Guatemala
  • Hungary
  • Israel
  • Italy
  • Malaysia
  • Mauritius
  • Mexico
  • Philippines
  • Poland
  • Russia
  • Saudi Arabia
  • Turkey
  • Ukraine
  • United Arab Emirates
  • United Kingdom
  • United States

Clinical Trial

MK-8835-059

20190614111729

2019-07-29

0000-00-00

6

Unspecified

NA

30 Sep 2020

Inclusion Criteria:
Has diabetes diagnosed by one of the American Diabetes Association (ADA) criteria.
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).
T2DM for ≥2 years, OR T2DM for 0.6 ng/mL at Screening.

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.
Contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
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.
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.

 

Exclusion Criteria:
Has known type 1 diabetes mellitus or documented evidence of positive diabetes autoantibodies performed when participant was diagnosed with diabetes.
Has known monogenic diabetes, or secondary diabetes.
Has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent, including insulin.
Has a known hypersensitivity or intolerance to any sodium glucose co-transporter 2 (SGLT2) inhibitor.
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.
Has previously taken an SGLT2 inhibitor (such as canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin) or was enrolled in a study for these agents.
Has a history of idiopathic acute pancreatitis or chronic pancreatitis.
Has a history of severe hypoglycemia while on insulin.

Interventional

Drug: Ertugliflozin 5 mg Ertugliflozin 5 mg, oral, 1 tablet QD Other Name: MK-8835 Drug: Placebo Placebo to ertugliflozin 15 mg, oral, 1 tablet QD Biological: Insulin The initiation and titration of insulin will be at the discretion of the investigator, based on local/regional/country guidelines. Drug: Metformin Participants will receive stable dose of background metformin.

Experimental: Ertugliflozin 5 mg/5 mg arm


All participants will initially receive ertugliflozin (ERTU) 5 mg once daily (QD) and placebo to ERTU 15 mg QD for 12 weeks. At the second randomization at Week 12 (WK12), all participants that do not meet the up-titration criteria will remain on ERTU 5 mg and placebo to ERTU 15 mg from WK12 to WK54. Approximately half the participants who meet the up-titration criteria at the second randomization at WK12 will also remain on ERTU 5 mg and placebo to ERTU 15 mg from WK12 to WK54.
Note: For participants not on insulin, the up-titration criterion at the second randomization at WK12 is HbA1C ≥7.0% (53 mmol/mol) and for participants on insulin, a fasting fingerstick glucose (FFSG) of ≥110 mg/dL (6.1 mmol/L) will be required in addition to HbA1C ≥7.0% (53 mmol/mol). Participants will remain on their background metformin with/without insulin treatment throughout the study.

Placebo Comparator: Placebo arm


At the first randomization, participants receive placebo to ERTU 5 mg and placebo to ERTU 15 mg QD for 12 weeks. Participants in the placebo group with HbA1C ≥7.0% (53 mmol/mol) at WK12 will be mock titrated. Note: The up-titration criteria for participants on insulin will include a FFSG of ≥110 mg/dL (6.1 mmol/L) in addition to HbA1C ≥7.0% (53 mmol/mol) at WK12. Participants will continue to receive placebo to ERTU 5 mg and placebo to ERTU 15 mg QD from WK24 to WK54. Participants will remain on their background metformin with/without insulin treatment throughout the study.

None

Randomized

Double Blind

Double Blind (Participant, Investigator)

Not Applicable

Treatment

Phase III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
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