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Phase 3 Alogliptin Pediatric Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02856113
Recruitment Status : Active, not recruiting
First Posted : August 4, 2016
Last Update Posted : August 10, 2021
Sponsor:
Collaborator:
Takeda Development Center Americas, Inc.
Information provided by (Responsible Party):
Takeda

Brief Summary:
The primary purpose of this study is to evaluate the efficacy of alogliptin 25 milligram (mg) once daily compared to placebo when administered as monotherapy, or when added onto a background of metformin alone, insulin alone, or a combination of metformin and insulin, as measured by the glycosylated hemoglobin (HbA1c) change from Baseline at Week 26 in pediatric participants with type 2 diabetes mellitus (T2DM).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Alogliptin Benzoate Drug: Placebo Phase 3

Detailed Description:

The drug being tested in this study is called alogliptin. Alogliptin is being tested to treat children 10 to 17 years of age who have T2DM and are experiencing inadequate glycemic control. This study will look at HbA1c fluctuations in children who take alogliptin in addition to their background antidiabetic therapy.

The study will enroll approximately 150 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

  • Alogliptin 25 mg
  • Placebo (dummy inactive pill) - this is a tablet that looks like the tablet containing alogliptin 25 mg but has no active ingredient (that is, has no alogliptin).

All participants will be asked to take one tablet at the same time each day throughout the study in addition to their current background antidiabetic therapy (metformin and/or insulin) if applicable.

This multi-center trial will be conducted in the United States, Brazil, Germany, Italy, Poland, Russia, Israel and Mexico. The overall time to participate in this study is approximately 56 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 2 weeks after the last dose of study drug for a follow-up assessment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alogliptin Compared With Placebo in Pediatric Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date : November 28, 2016
Actual Primary Completion Date : August 6, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alogliptin 25 mg
Alogliptin 25 mg tablets, orally, once daily for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
Drug: Alogliptin Benzoate
Alogliptin benzoate tablets.
Other Names:
  • SYR-322
  • Nesina
  • Vipidia

Placebo Comparator: Placebo
Alogliptin placebo-matching tablets, orally, once daily for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
Drug: Placebo
Alogliptin placebo-matching tablets.




Primary Outcome Measures :
  1. Change From Baseline in HbA1c at Week 26 [ Time Frame: Baseline and Week 26 ]
    The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 26 relative to Baseline.


Secondary Outcome Measures :
  1. Change From Baseline in HbA1c at Weeks 12, 18, 39 and 52 [ Time Frame: Baseline and Weeks 12, 18, 39 and 52 ]
    The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 12, 18, 39 and 52 relative to Baseline.

  2. Percentage of Participants with Abnormal Physical Examination Findings [ Time Frame: From Day 1 to end of treatment period (up to 52 weeks) ]
  3. Percentage of Participants With Abnormal Vital Signs Values [ Time Frame: From Day 1 to end of treatment period (up to 52 weeks) ]
    Vital signs will include body temperature (oral or tympanic measurement), respiratory rate, blood pressure (resting more than 5 minutes), and pulse (beats per minute).

  4. Percentage of Participants with Abnormal 12-lead Electrocardiogram (ECG) Findings [ Time Frame: From Day 1 to end of treatment period (up to 52 weeks) ]
  5. Percentage of Participants with Treatment-emergent Adverse Events (TEAE) [ Time Frame: From Day 1 to end of the study (up to 54 weeks) ]
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.

  6. Percentage of Participants with Infections and Hypersensitivity Reactions [ Time Frame: From Day 1 to end of treatment period (up to 52 weeks) ]
    Percentage of participants with infections (total) and urinary tract infections (UTIs) and respiratory tract infection (RTI) will be reported.

  7. Percentage of Participants with Hypoglycemia [ Time Frame: From Day 1 to end of treatment period (up to 52 weeks) ]
    Mild to moderate hypoglycemia (abnormal low blood sugar) is defined as blood glucose less than (<) 60 milligram per deciliter (mg/dL) (3.33 millimole per liter [mmol/L]) in the presence of symptoms, or blood glucose <50 mg/dL (2.78 mmol/L) with or without symptoms. Severe hypoglycemia is defined as any episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, associated with a documented blood glucose <60 mg/dL (3.33 mmol/L) (unless the clinical situation makes obtaining a blood glucose difficult [example, it involves coma or seizure]).

  8. Percentage of Participants with Abnormal Safety Laboratory Findings [ Time Frame: From Day 1 to end of treatment period (up to 52 weeks) ]
    The percentage of participants with any abnormal standard safety laboratory values (hematology, serum chemistry, and urinalysis) will be collected throughout study.

  9. Change from Baseline in Biomarkers of Bone Turnover at Weeks 26 and 52 [ Time Frame: Baseline, Weeks 26 and 52 ]
    Biomarkers of bone turnover are bone-specific alkaline phosphatase to assess changes in bone formation and C-terminal telopeptide (CTX) to assess changes in bone resorption.

  10. Change from Baseline in CD26 Surface Antigen Levels at Weeks 26 and 52 [ Time Frame: Baseline, Weeks 26 and 52 ]
    The change in the value of CD26 surface antigen collected at Week 26 and Week 52 relative to Baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has a confirmed diagnosis of T2DM using American Diabetes Association (ADA) and World Health Organization (WHO) criteria (laboratory determinations of fasting plasma glucose [FPG] greater than or equal to [>=] 126 mg/dL, random glucose >=200 mg/dL [>=11.10 mmol/L], HbA1c >=6.5 percent (%), or 2-hour oral glucose tolerance test [OGTT] glucose >=200 mg/dL), documented in the participants' medical record.
  2. The participant and/or his/her legal representative (that is, parents or legal guardians) are able and willing to monitor their own blood glucose concentrations with a home glucose monitor and complete participant diaries.

Exclusion Criteria:

  1. Has a history of hypersensitivity or allergy to alogliptin, other dipeptidyl peptidase-4 (DPP-4) inhibitors, metformin, insulin or related compounds.
  2. Has a confirmed diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young (MODY).
  3. Has a hemoglobin level <11.0 gram per deciliter (g/dL) (<110 gram per liter [g/L]) for males and <10.0 g/dL (<100 g/L) for females.
  4. Has a history of any hemoglobinopathy that may affect determination of HbA1c levels.
  5. Has a history of bariatric surgery.
  6. Has a history of proliferative diabetic retinopathy within the 6 months prior to Screening.
  7. Has had more than 1 episode of diabetic ketoacidosis (DKA) at any time after diagnosis of T2DM.
  8. Has a history of more than 1 episode of pancreatitis.
  9. Has serum creatinine >=1.5 mg/dL for male participants or >=1.4 mg/dL for female participants, or creatinine clearance <60 milliliter per minute (mL/min) based on calculation by central lab using the Schwartz formula for estimated glomerular filtration rate (eGFR) at screening Visit.
  10. Has a documented history of infection with human immunodeficiency virus or chronic active viral hepatitis.
  11. The participant and/or his/her legal representative (that is, parents or legal guardians) is unable to understand verbal or written English, or any other language for which a certified translation of the approved informed consent/assent is available.

Additional Criteria That Must be Met Prior to Randomization:

For participants who have had the diagnosis of T2DM for less than 1 year and/or who are taking insulin at Screening, additional criteria will need to be met prior to randomization:

  1. Must have an HbA1c level of >=6.5% to <11.0% if the participant is treatment naïve or on metformin alone or >=7.0% to <11.0% if the participant is on insulin alone or in combination with metformin.
  2. The participant must not have received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to randomization.
  3. Must not have received an antidiabetic agent other than metformin or insulin within the 12 weeks prior to randomization.
  4. Must not have received oral or parenteral steroids for more than 3 weeks (cumulatively) within the 6 months prior to randomization or have received a course of oral or parenteral steroids within the 2 months prior to randomization.
  5. Has a systolic blood pressure <160 millimeter of mercury (mmHg) and a diastolic pressure <100 mm Hg. (Antihypertensive medications will be allowed during the study).
  6. Has an alanine aminotransferase (ALT) level <3*upper limit of normal (ULN) or an ALT level <5 *ULN with a confirmed diagnosis of nonalcoholic fatty liver disease (NAFLD).7. Does not plan to leave the geographic area within 1 calendar year following randomization.

For participants who have had the diagnosis of T2DM for less than 1 year and/or who are taking insulin prior to randomization, the following criteria must also be met:

8. Must have a fasting C-peptide concentration>=0.6 nanogram per milliliter (ng/mL) (>=0.20 nanomole per liter [nmol/L]) (drawn at least 1 week after treatment for ketosis or acidosis, if applicable).

9. No presence of autoantibodies as documented by glutamic acid decarboxylase [GAD] 65 and islet antigen [IA]-2 antibodies below the upper limit of the normal reference ranges at randomization.

10. Have a body mass index (BMI) greater than (>) 85th percentile, documented at randomization.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856113


Locations
Show Show 55 study locations
Sponsors and Collaborators
Takeda
Takeda Development Center Americas, Inc.
Investigators
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Study Director: Medical Director Clinical Science Takeda
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02856113    
Other Study ID Numbers: SYR-322_309
U1111-1174-1923 ( Registry Identifier: WHO )
2015-000208-25 ( EudraCT Number )
173300410A0019 ( Registry Identifier: NREC )
MOH_2017-12-26_000698 ( Other Identifier: CRS )
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Alogliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action