Ertugliflozin Pediatric Study
- Conditions
- Type 2 diabetes mellitusMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2017-003455-35-GB
- Lead Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
1. Have T2DM as indicated by yes” answers to all of the following:
i. Participant has diabetes diagnosed by one of the following American Diabetes Association (ADA) criteria, eg:
a) Laboratory determinations of FPG =126 mg/dL (7.0 mmol/L), OR
b) Random plasma glucose =200 mg/dL (11.1 mmol/L), OR
c) 2-hour oral glucose tolerance test (OGTT) plasma glucose =200 mg/dL (11.1 mmol/L), OR
d) A1C =6.5% (48 mmol/mol) test performed using a method that is National Glycohemoglobin Standardization Program (NGSP) certified and standardized to the Diabetes Control and Complications Trial (DCCT) assay
ii. Participant has BMI =85th percentile at screening OR
participant has a history of being overweight or obese at time of diagnosis of T2DM
2. Have:
i. T2DM for =2 years, OR
ii. T2DM for <2 years and a fasting C-peptide value >0.6 ng/mL at Screening Visit/Visit 1
3. Be:
i. On stable metformin monotherapy (=1500 mg/day, for =8 weeks prior to Screening Visit/Visit 1), OR
ii. On a stable metformin dose (=1500 mg/day, for =8 weeks prior to Screening Visit/Visit 1) and a stable dose of insulin (of any type, variance in dose to be =15% of total daily dose for =8 weeks prior to Screening Visit/ Visit 1)
4. Have an A1C =6.5% and =10.0% (48 mmol/mol and 86 mmol/mol) at Screening Visit/Visit 1 if on metformin monotherapy, OR an A1C =7.0% and =10.0% (53 mmol/mol and 86 mmol/mol) at Screening Visit/Visit 1 if on metformin + insulin
5. Be male or female, =10 years and =17 years of age, when the informed consent is signed by the legally acceptable representative, and randomization (Visit 3/Day 1/Randomization) will occur prior to the participant's 18th birthday
6. Contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
7. Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
8. Be a female participant who is unlikely to conceive as indicated by at least 1 yes” response to the following which will remain consistent for the projected duration of the study and for 14 days after the last dose of study treatment:
i. Participant is a non-sterilized female who is currently not sexually active and agrees to follow statement iii” if heterosexual activity is initiated, OR
ii. Participant is a non-sterilized female who agrees to abstain from heterosexual activity
iii. Participant is a non-sterilized female who agrees to start contraception prior to initiating sexual activity and who agrees to use an adequate method of contraception
9. Have a legally acceptable representative who understands the study procedures,alternative treatments available and risks involved with the study, and voluntarily agrees to the child's participation by giving informed written consent, and the participant has an age-appropriate understanding of the same by giving informed written assent. In addition, the legally acceptable representative may also consent to have the child participate in Future Biomedical Research (FBR) by signing a separate consent. Otherwise eligible participants will be able to participate in the main study even if they opt to not participate in FBR
10. 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 stud
At Screening Visit/Visit 1
1. Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
2. Has known type 1 diabetes mellitus or documented evidence of positive diabetes autoantibodies performed when participant was diagnosed with diabetes
3. Has known monogenic diabetes, or secondary diabetes
4. Has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent, including insulin
5. Has active, obstructive uropathy or indwelling urinary catheter
6. Has history of malignancy =5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
7. Has a known hypersensitivity or intolerance to any SGLT2 inhibitor
8. Has active liver disease (other than non-alcoholic hepatic steatosis) by history, including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
9. Has active nephropathy or abnormalities of genitourinary tract that predispose to recurrent urinary tract infections
10. Meets any of the following criteria:
i. Participant is on a weight-loss program and is not weight-stable
ii. Participant is on a weight-loss or weight changes medications and is not weight-stable
iii. Participant had bariatric surgery at any time in the past
11. Has been previously diagnosed with disorders of growth or bone metabolism
12. Has a clinically significant hematological disorder (such as aplastic anemia, thrombocytopenia, myeloproliferative or myelodysplastic syndrome)
13. 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
14. Has been treated with a sulfonylurea, metiglinide, alpha glucosidase inhibitor, DPP-4 inhibitor, or incretin-based agent in the 8 weeks prior to Screening Visit/Visit 1
15. Has been treated with a thiazolidinedione in the 16 weeks prior to Screening Visit/Visit 1
16. Is taking blood pressure medication(s) and will not be on a stable dose for at least 4 weeks prior to Visit 3/Day 1/Randomization.
17. Is currently being treated for hyperthyroidism
18. Is on, or likely to require treatment with, =14 consecutive days or repeated courses of pharmacologic doses of corticosteroids
19. Has previously taken an SGLT2 inhibitor (such as canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin) or was enrolled in a study for these agents
20. Has a Screening Visit/Visit 1 SBP or diastolic blood pressure (DBP) = 95th percentile for age, height percentile, and gender and is not considered likely to have values <95th percentile for age, height percentile and gender by Visit 3/Day 1/Randomization even with appropriate antihypertensive therapy
21. Has fasting serum triglyceride >500 mg/dL (5.65 mmol/L) at Screening Visit /Visit 1, confirmed by a single repeat if deemed necessary
22. Has an eGFR <45 mL/min/1.73m2 at Screening Visit/ Visit 1
23. Has an aspartate transaminase (AST) or alanine transaminase (ALT) >2.5X the upper limit of normal (ULN) at Screening Visit/ Visit 1, or a total bilirubin >1.5X the ULN unless the participant has a history of Gilbert syndrome
24. Has hemoglobin levels below normal range for age and sex at Screening Visit/Visit 1
25. Has thyroid-stimulating hormone (TSH) levels outside normal range at Screening Visit/ Visit 1
26. Has a history of idiopathic acute pancreatitis or chro
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method