Ertugliflozin Pediatric Study

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-003455-35-IT
• Lead Sponsor: MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-14
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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/Week 0/Day 1) 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 living 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 treatmen

Exclusion Criteria

Screen Visit/Visit 1
1immed family member investigat site o Spons staff involved with this study
2known type1diab mellitus o evidence positive diab autoantibodies perfomed when particip was diagn with diab
3know monogenic diab,o sec diabetes
4symptom hyperglyc and/o moderate to large ketonuria requiring immed initiat of other antihyperglyc agent, includ insulin
5active, obstruct uropathy o urinary catheter
6hist malignancy<=5years prior signing inform cons, exc for adequ treated basal cell o squam cell skin cancer,o in situ cervical cancer
7know hypersensit o intoler to SGLT2inhib
8act liver disease(other than nonalcoholic hepatic steat)by hist, includ chronic act hepatitisBoC, primary biliary cirrhosis, o sympt gallbladder disease
9act nephrop o abnorm genitourinary tract that predisp to recurrent urinary tract infections
10any of follow crit:Particip on a weightloss program and not weight-stable,Part on weight-loss medic and isnot weightstable, Part on medicat associated with weight changes, Part had bariatric surgery any time past
11prev diagnos with disoders growth o bone metabolism
12clinic signif hemat disoder(aplastic anemia, thrombocyt, myeloprolif o myelodysplastic syndr)
13pregnant,breast feeding,expecting to conceive o don eggs during stud,includ14days following last dose of stu medicat
14treat with sulfonylurea,metiglinide,alpha glucosidase inhib,DPP4 inhib, o incretin-based agent in8weeks prior Screen Vis/Vis1
1treat with thiazolidinedione in16weeks prior ScreenVis/Vis1
16taking blood press medic and not on stable dose for at least4weeks prior randomiz
17current treat for hyperthyr
18on, o likely to require treatm with>=14 consec days o repeated courses of pharma doses of coticosteroids
19prev taken SGLT2 inhib(canagliflozin,dapagliflozin,empagliflozin,ertugliflozin)or enrolled in stud for these agents
20HasScreen Visit/Visit1 SBPoDBP>=95th percent for age, height perc gender and not consider likely to have values<95th perc age, height perc and gender byVis3/Week 0/Day1/Random even with appropr antihypertens ther
21fast serum triglyc>500mg/dL(5.65 mmol/L)ScreenVis/Vis1,confirm single repeat if deem neces
22eGFR<45 mL/min/1.73m2 ScreenVis/Vis1
23ASToALT>2.5X theULN atScreen Vis/ Vis1,tot bilirubin>1.5X the ULN unless particip has hist of Gilbert syndr
24hemoglobin levels below nomal range age and sex atScreen Vis/Vis1
25TSH levels outside nomal range atScreen Vis/ Vis1
26hist of idiopathic acute pancreatitis o chronic pancreatitis
27hist of sev hypoglyc while on insulin
28known hist of illicit drug use, or alcohol abuse or depend(within past year)
29donated blood prod or phlebotomy of >10% of estimated tot blood vol within8weeks of signing inform consent or intends donate blood prod or receive blood prod within projected durat of study
30unlikely adhere to study proced and appointment schedule,planning to relocate outside of geogr area dur study, or poor mental funct, or legally accept represent is in opinion of invest, incapacitated prevent inform cons from being obt
31his or current evid of cond, ther, lab abnormality or circumstance which, in opin of invest, might pose risk to partic, make partic not in part’s interest, might confound results of study, or interfere with part’s involvem for full durat of study
Visit2/Week1
32symptom hyperglyc o ketonuria
33clinic significECGabnorm that requires further diagnostic eval o interv which,opinion investig, exposes particip to risk by enrolling stud.prolong

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified