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

NCT04029480

Last updated date
Study Location
AOU Federico II di Napoli ( Site 0902)
Napoli, , 80123, Italy
Contact
1-888-577-8839

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Advanced Information
Descriptive Information
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
  • Drug: Ertugliflozin 5 mg
    Ertugliflozin 5 mg, oral, 1 tablet QD
    Other Name: MK-8835
  • Drug: Ertugliflozin 15 mg
    Ertugliflozin 15 mg, oral, 1 tablet QD
    Other Name: MK-8835
  • Drug: Placebo
    Placebo to ertugliflozin 15 mg, oral, 1 tablet QD
  • Drug: Placebo
    Placebo to ertugliflozin 5 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.
Study Arms  ICMJE
  • Experimental: Ertugliflozin 5 mg/5 mg

    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.

    Interventions:
    • Drug: Ertugliflozin 5 mg
    • Drug: Placebo
    • Biological: Insulin
    • Drug: Metformin
  • Experimental: Ertugliflozin 5 mg/15 mg

    All participants will initially receive ERTU 5 mg QD and placebo to ERTU 15 mg QD for 12 weeks. At the second randomization at WK12, approximately half the participants who meet the up-titration criteria at the second randomization will up-titrate to ERTU 15 mg and placebo to ERTU 5 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 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.

    Interventions:
    • Drug: Ertugliflozin 5 mg
    • Drug: Ertugliflozin 15 mg
    • Drug: Placebo
    • Biological: Insulin
    • Drug: Metformin
  • Placebo Comparator: Placebo
    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.
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
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
 (submitted: July 22, 2019)
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:

  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.

Exclusion Criteria:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Toll Free Number1-888-577-8839[email protected]
Listed Location Countries  ICMJE Belgium,   Canada,   Colombia,   Costa Rica,   Dominican Republic,   France,   Guatemala,   Hungary,   Israel,   Italy,   Malaysia,   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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL:http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Medical DirectorMerck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date July 2020

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