This study evaluated the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without insulin. The primary hypothesis of the study was that the addition of ertugliflozin reduces hemoglobin A1C (HbA1C) more than the addition of placebo after 24 weeks of treatment.
Participants were randomized on Day 1 to the following arms: * 5 mg ERTU and placebo to 15 mg ERTU (5 mg Ertugliflozin) * placebo to 5 mg ERTU and placebo to 15 mg ERTU (Placebo) At Week 12, participants who met the up-titration criteria were re-randomized to the following arms for Weeks 12 to 54: * 5 mg ERTU and placebo to 15 mg ERTU (5 mg/5 mg Ertugliflozin) * 15 mg ERTU and placebo to 5 mg ERTU (5 mg/15 mg Ertugliflozin) Participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU from Week 12 to Week 54. The placebo arm continued receiving placebo from Week 12 to Week 54.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
166
Ertugliflozin 5 mg, oral, 1 tablet QD
Ertugliflozin 15 mg, oral, 1 tablet QD
Placebo to ertugliflozin 15 mg, oral, 1 tablet QD
Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo)
Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the A1C change from baseline (i.e., % A1C at Week 24 minus % A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. The Bayesian mean change from baseline for each combined ertugliflozin and placebo are reported. Per protocol, the ertugliflozin arms are combined for this analysis.
Time frame: Baseline and Week 24
Number of Participants Who Experienced an Adverse Event (AE) Up to Week 24
An adverse event -- Select --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. Per protocol, the ertugliflozin arms are combined for this analysis.
Time frame: Up to Week 24
Number of Participants Who Experienced an AE Up to Week 54
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. Per protocol, the ertugliflozin arms are combined for this analysis.
Time frame: Up to Week 54
Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 24
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. Per protocol, the ertugliflozin arms are combined for this analysis.
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Placebo to ertugliflozin 5 mg, oral, 1 tablet QD
Participants on insulin at screening continued to receive a stable dose of background insulin. The initiation and titration of insulin for rescue therapy was at the discretion of the investigator, based on local/regional/country guidelines.
Participants received stable dose of background metformin.
The University of Alabama at Birmingham ( Site 2207)
Birmingham, Alabama, United States
Children's Hospital - Los Angeles ( Site 2201)
Los Angeles, California, United States
Center of Excellence in Diabetes and Endocrinology ( Site 2203)
Sacramento, California, United States
Memorial Regional Hospital-Joe DiMaggio Children's Hospital Division of Pediatric Endocrinology ( Si
Hollywood, Florida, United States
ICCT Research International, Inc. ( Site 2211)
Chicago, Illinois, United States
Barry J. Reiner MD LLC ( Site 2204)
Baltimore, Maryland, United States
William Beaumont Hospital ( Site 2219)
Royal Oak, Michigan, United States
CHEAR Center LLC ( Site 2200)
The Bronx, New York, United States
Coastal Children''s Services ( Site 2202)
Wilmington, North Carolina, United States
The Children's Hospital of Philadelphia ( Site 2205)
Philadelphia, Pennsylvania, United States
...and 94 more locations
Time frame: Up to Week 24
Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 54
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. Per protocol, the ertugliflozin arms are combined for this analysis.
Time frame: Up to Week 54
Change From Baseline in Hemoglobin A1C at Week 24 (Dose-optimized Ertugliflozin Versus Placebo)
Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the A1C change from baseline (i.e., % A1C at Week 24 minus % A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Week 24
Change From Baseline in Hemoglobin A1C at Week 24 (5 mg Ertugliflozin Versus Placebo)
Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the A1C change from baseline (i.e., % A1C at Week 24 minus % A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
Time frame: Baseline and Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Blood glucose is 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). A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Per protocol, the ertugliflozin arms were combined for this analysis.
Time frame: Baseline and Week 24
Change From Baseline in Hemoglobin A1C at Week 54
Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 54 to determine the A1C change from baseline (i.e., A1C at Week 54 minus A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. Per protocol, the ertugliflozin arms were combined for this analysis.
Time frame: Baseline and Week 54
Change From Baseline in FPG at Week 54
Blood glucose is 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). A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Per protocol, the ertugliflozin arms were combined for this analysis.
Time frame: Baseline and Week 54