Clinical trial NCT04029480: Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2019-07-23
Enrollment: 165
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Hemoglobin A1C (HbA1C) at 24 weeks (pooled ertugliflozin 5 mg and 15 mg versus placebo)
timeFrame: Baseline and 24 weeks
measure: Number of Participants Who Experience an Adverse Event (AE) over 24 weeks
timeFrame: Up to 24 weeks
measure: Number of Participants Who Experience an AE over 54 weeks
timeFrame: Up to 54 weeks
measure: Number of Participants Who Discontinue Study Treatment Due to an AE over 24 weeks
timeFrame: Up to 24 weeks
measure: Number of Participants Who Discontinue Study Treatment Due to an AE over 54 weeks
timeFrame: Up to 54 weeks
Secondary outcomes:
measure: Change from Baseline in Hemoglobin A1C at Week 24 (dose-optimized ertugliflozin versus placebo)
timeFrame: Baseline and 24 weeks
measure: Change from Baseline in Hemoglobin A1C at Week 24 (ertugliflozin 5 mg versus placebo)
timeFrame: Baseline and 24 weeks
measure: Change from Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks
timeFrame: Baseline and 24 weeks
measure: Change from Baseline in Hemoglobin A1C at 54 Weeks
timeFrame: Baseline and 54 weeks
measure: Change from Baseline in FPG at 54 Weeks
timeFrame: Baseline and 54 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham ( Site 2207)
state: Alabama
city: Los Angeles
country: United States
facility: Children's Hospital - Los Angeles ( Site 2201)
state: California
city: Sacramento
country: United States
facility: Center of Excellence in Diabetes and Endocrinology ( Site 2203)
state: California
city: Hollywood
country: United States
facility: Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si
state: Florida
city: Chicago
country: United States
facility: ICCT Research International, Inc. ( Site 2211)
state: Illinois
city: Baltimore
country: United States
facility: Barry J. Reiner MD LLC ( Site 2204)
state: Maryland
city: Royal Oak
country: United States
facility: William Beaumont Hospital ( Site 2219)
state: Michigan
city: Bronx
country: United States
facility: CHEAR Center LLC ( Site 2200)
state: New York
city: Wilmington
country: United States
facility: Coastal Children''s Services ( Site 2202)
state: North Carolina
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia ( Site 2205)
state: Pennsylvania
city: Mesquite
country: United States
facility: Southern Endocrinology and Associates PA ( Site 2218)
state: Texas
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc ( Site 2300)
state: Bruxelles-Capitale, Region De
city: London
country: Canada
facility: London Health Sciences Centre ( Site 0002)
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0001)
state: Quebec
city: Barranquilla
country: Colombia
facility: Centro De Diabetes Cardiovascular IPS Ltda ( Site 0101)
state: Atlantico
city: Bogota
country: Colombia
facility: MedPlus Medicina Prepagada S.A. ( Site 0102)
state: Distrito Capital De Bogota
city: San Jose
country: Costa Rica
facility: Clinica Los Yoses ( Site 0200)
city: Santo Domingo
country: Dominican Republic
facility: Hospital Infantil Dr. Robert Reid Cabral ( Site 0300)
state: Distrito Nacional
city: Dijon
country: France
facility: CHU du BOCAGE ( Site 0407)
state: Cote-d Or
city: Amiens
country: France
facility: CHU Amiens Hopital Sud ( Site 0413)
state: Picardie
city: Chiquimula
country: Guatemala
facility: Consultorio Privado Dr. Geraldine Utrilla ( Site 0501)
city: Guatemala City
country: Guatemala
facility: Private Practice - Dr. Flor de Maria Ranchos Monterroso ( Site 0502)
city: Guatemala
country: Guatemala
facility: Endopedia ( Site 0503)
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont Gyermekgyogyaszati Klinika ( Site 0708)
state: Baranya
city: Békéscsaba
country: Hungary
facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-Gyermekosztály ( Site 0705)
state: Bekescsaba
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0701)
state: Borsod-Abauj-Zemplen
city: Székesfehérvár
country: Hungary
facility: Vita Verum Medical Egeszsegugyi Szolgaltato Bt ( Site 0706)
state: Fejer
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz ( Site 0709)
state: Gyor-Moson-Sopron
city: Nyiregyhaza
country: Hungary
facility: Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 0704)
state: Szabolcs-Szatmar-Bereg
city: Budapest
country: Hungary
facility: Heim Pal Orszagos Gyermekgyogyaszati Intezet ( Site 0702)
city: Budapest
country: Hungary
facility: Semmelweis Egyetem II. sz. Gyermekgyogyaszati Klinika ( Site 0703)
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center ( Site 0802)
city: Haifa
country: Israel
facility: Armon M.C ( Site 0803)
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 0801)
city: Jerusalem
country: Israel
facility: Hadassah Mount Scopus ( Site 0800)
city: Ramat Gan
country: Israel
facility: The Edmond and Lily Safra Children s Hospital ( Site 0804)
city: Firenze
country: Italy
facility: A.O.Universitaria Meyer ( Site 0901)
state: Toscana
city: Caltanissetta
country: Italy
facility: U.O. di Diabetologia dell'Eta Evolutiva - AUSL 2 ( Site 0904)
city: Genova
country: Italy
facility: IRCCS G. Gaslini ( Site 0900)
city: Napoli
country: Italy
facility: AOU Federico II di Napoli ( Site 0902)
city: Roma
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0903)
city: Torino
country: Italy
facility: Ospedale Regina Margherita ( Site 0905)
city: Kubang Kerian
country: Malaysia
facility: Hospital Universiti Sains Malaysia ( Site 1102)
state: Kelantan
city: Taiping
country: Malaysia
facility: Hospital Taiping ( Site 1104)
state: Perak
city: Georgetown
country: Malaysia
facility: Hospital Pulau Pinang. ( Site 1101)
state: Pulau Pinang
city: Putrajaya
country: Malaysia
facility: Hospital Putrajaya ( Site 1103)
state: Wilayah Persekutuan Putrajaya
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre ( Site 1100)
city: Forbach
country: Mauritius
facility: Life Nova+ ( Site 1203)
state: Pamplemousses
city: Moka
country: Mauritius
facility: Wellkin Hospital ( Site 1200)
city: Ciudad de México
country: Mexico
facility: Bio Investigación AMARC, S.C. ( Site 1006)
state: Distrito Federal
city: Mexico
country: Mexico
facility: CAIMED Investigación en Salud S.A de C.V ( Site 1008)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Unidad de Investigacion Clinica Cardiometabolica de Occidente ( Site 1007)
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Medica de Occidente S.C. ( Site 1001)
state: Jalisco
city: Monterrey
country: Mexico
facility: Unidad Biomedica Avanzada Monterrey S. A. ( Site 1005)
state: Nuevo Leon
city: San Juan del Río
country: Mexico
facility: Unidad de Medicina Especializada SMA ( Site 1004)
state: Queretaro
city: Culiacan
country: Mexico
facility: Consultorio Medico de Endocrinologia Pediatrica ( Site 1002)
state: Sinaloa
city: Madero
country: Mexico
facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 1003)
state: Tamaulipas
city: Aguascalientes
country: Mexico
facility: Centro de Investigacion Medica Aguascalientes ( Site 1000)
city: Aguascalientes
country: Mexico
facility: Centro de Atencion e Investigacion Clinica SC ( Site 1009)
city: Davao City
country: Philippines
facility: Davao Doctors Hospital ( Site 1400)
state: Davao Del Sur
city: Marikina
country: Philippines
facility: Institute for Studies on Diabetes Foundation Inc. ( Site 1402)
state: National Capital Region
city: Iloilo
country: Philippines
facility: West Visayas State University Medical Center ( Site 1401)
city: Bydgoszcz
country: Poland
facility: IN VIVO ( Site 1501)
state: Kujawsko-pomorskie
city: Wierzchoslawice
country: Poland
facility: Poradnia Chorob Metabolicznych. Centrum Zdrowia Tuchow ( Site 1500)
state: Malopolskie
city: Warszawa
country: Poland
facility: Instytut Diabetologii Sp z o o ( Site 1512)
state: Mazowieckie
city: Katowice
country: Poland
facility: Clinical Medical Research Sp. z o.o. ( Site 1511)
state: Slaskie
city: Ufa
country: Russian Federation
facility: Bashkir State Medical University Hospital ( Site 1603)
state: Baskortostan, Respublika
city: Moscow
country: Russian Federation
facility: Federal State Budget Institution Endocrinological Research Center ( Site 1611)
state: Moskva
city: Novosibirsk
country: Russian Federation
facility: Children's City Clinical Hospital #1 ( Site 1604)
state: Novosibirskaya Oblast
city: Rostov-on-Don
country: Russian Federation
facility: Rostov Scientific Research Institution of Obstetrics and Pediatry ( Site 1606)
state: Rostovskaya Oblast
city: Samara
country: Russian Federation
facility: Samara City Pediatric Clinical Hospital n.a. N.N. Ivanova ( Site 1610)
state: Samarskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: St.Petersburg State Pediatric Medical University ( Site 1600)
state: Sankt-Peterburg
city: Kazan
country: Russian Federation
facility: Kazan State Medical University ( Site 1601)
state: Tatarstan, Respublika
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University ( Site 1602)
state: Tomskaya Oblast
city: Voronezh
country: Russian Federation
facility: Voronezh State Medical University named after N.N.Burdenko ( Site 1608)
state: Voronezskaja Oblast
city: Mecca
country: Saudi Arabia
facility: Hera General Hospital ( Site 1725)
state: Al BaHah
city: Al Ahsa
country: Saudi Arabia
facility: King Abdulaziz Medical City - Al Ahsa ( Site 1730)
state: Ar Riyad
city: Riyadh
country: Saudi Arabia
facility: King Abdul Aziz Medical City - AlRiyadh ( Site 1700)
state: Ar Riyad
city: Riyadh
country: Saudi Arabia
facility: King Abdul Aziz Medical City - AlRiyadh ( Site 1705)
state: Ar Riyad
city: Riyadh
country: Saudi Arabia
facility: King Salman bin Abdulaziz hospital - Al Riyadh ( Site 1720)
state: Ar Riyad
city: Riyadh
country: Saudi Arabia
facility: King Salman bin Abdulaziz hospital Al Riyadh ( Site 1710)
state: Ar Riyad
city: Jeddah
country: Saudi Arabia
facility: King Abdul Aziz Medical City. National Guard Health Affairs ( Site 1715)
state: Makkah Al Mukarramah
city: Istambul
country: Turkey
facility: I. U. Cerrahpasa Tip Fakultesi ( Site 2406)
state: Istanbul
city: Adana
country: Turkey
facility: Cukurova Uni. Tip Fakultesi ( Site 2403)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Çocuk Hastanesi, Çocuk Endokrinoloji ( Site 2407)
city: Istanbul
country: Turkey
facility: Marmara Üniversitesi Prof. Dr. Asaf Ataseven Hospital ( Site 2400)
city: Chernivtsi
country: Ukraine
facility: Chernivtsi Regional Children Clinical Hospital No. 1-Department of Pediatrics and Medical Genetics (
state: Chernivetska Oblast
city: Dnipro
country: Ukraine
facility: SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1914)
state: Dnipropetrovska Oblast
city: Kharkiv
country: Ukraine
facility: MHI Regional Childrens Clinical Hospital ( Site 1908)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: Institute of Children and Adolescents Health Care of the Academy of Medical Sciences ( Site 1915)
state: Kharkivska Oblast
city: Kyiv
country: Ukraine
facility: Ukr Center of Endocrine Surgery and Transplatation MOH Ukraine ( Site 1903)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Medical Center Verum ( Site 1913)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Institute of Endocrinology and Metabolism n.a. Komissarenko ( Site 1905)
state: Kyivska Oblast
city: Odesa
country: Ukraine
facility: Odessa Regional Children Clinical Hospital ( Site 1912)
state: Odeska Oblast
city: Vinnytsia
country: Ukraine
facility: Vinnitsa Regional Endocrinology Dispensary, VNMU n.a. M.I.Pyrogov ( Site 1901)
state: Vinnytska Oblast
city: Dubai
country: United Arab Emirates
facility: Dubai Diabetes Center ( Site 2002)
state: Dubayy
city: Dubai
country: United Arab Emirates
facility: Mustafa Al Qaysi Medical Centre ( Site 2010)
state: Dubayy
city: Dubai
country: United Arab Emirates
facility: Mediclinic City Hospital ( Site 2005)
state: Dubayy
city: Dubai
country: United Arab Emirates
facility: Al Jalila Children s Specialty Hospital ( Site 2004)
state: Dubayy
city: Ajman
country: United Arab Emirates
facility: Thumbay University Hospital ( Site 2001)
city: Ajman
country: United Arab Emirates
facility: Rashid Center For Diabetes and Research ( Site 2006)
city: London
country: United Kingdom
facility: Royal London Hospital (Whitechapel) ( Site 2100)
state: London, City Of
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital ( Site 2103)
state: London, City Of
city: London
country: United Kingdom
facility: West Middlesex University Hospital ( Site 2104)
state: London, City Of
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: