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Trial record 2 of 63 for:    alogliptin

Phase 3 Alogliptin Pediatric Study

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ClinicalTrials.gov Identifier: NCT02856113
Recruitment Status : Recruiting
First Posted : August 4, 2016
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
This study will evaluate the efficacy and safety of alogliptin 25 mg once daily (QD) 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 in pediatric participants 10 to 17 years of age 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 type 2 diabetes mellitus (T2DM) and are experiencing inadequate glycemic control. This study will look at glycosylated hemoglobin (HbA1c) fluctuations in children who take alogliptin in addition to their background antidiabetic therapy.

The study will enroll approximately 200 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient 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 25mg but has no active ingredient (i.e. 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 worldwide. 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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
Estimated Primary Completion Date : June 11, 2021
Estimated Study Completion Date : June 11, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Alogliptin 25 mg
Alogliptin benzoate 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 benzoate 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 benzoate placebo-matching tablets



Primary Outcome Measures :
  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 [ Time Frame: Baseline and Week 26 ]
    The change in the value of glycosylated hemoglobin (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 glycosylated hemoglobin (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 Exam Findings [ Time Frame: From Day 1 to end of treatment period (up to 52 weeks) ]
    Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10).

  3. Percentage of Participants with Abnormal Electrocardiogram (ECG) Findings [ Time Frame: From Day 1 to end of treatment period (up to 52 weeks) ]
    A standard 12-lead ECG will be recorded. The Investigator will interpret the ECG using 1 of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.

  4. Percentage of Participants with Treatment-Emergent Adverse Events (TEAE) [ Time Frame: From Day 1 to end of treatment period (up to 52 weeks) ]
    An Adverse Event (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. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.

  5. Percentage of Participants with Infections [ 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) will be reported.

  6. 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 <60 mg/dL (3.33 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 [eg, it involves coma or seizure]).

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

  8. Change from Baseline in Bone Mineral Density at Weeks 26 and 52 [ Time Frame: Baseline and Weeks 26 and 52 ]
    The change in the value of bone mineral density collected at Week 26 and Week 52 relative to Baseline. Bone mineral density will be evaluated using dual X-ray absorptiometry (DXA) scans.

  9. Change from Baseline in Biomarkers of Bone Turnover at Weeks 26 and 52 [ Time Frame: Baseline and Weeks 26 and 52 ]
    The change in the value of biomarkers of bone turnover collected at Week 26 and Week 52 relative to Baseline. 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 and 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 type 2 diabetes mellitus (T2DM) using American Diabetes Association (ADA) and World Health Organization (WHO) criteria (laboratory determinations of fasting plasma glucose (FPG) ≥126 mg/dL, random glucose ≥200 mg/dL [≥11.10 mmol/L], glycosylated hemoglobin (HbA1c) ≥6.5%, or 2-hour oral glucose tolerance test [OGTT] glucose ≥200 mg/dL), documented in the participants' medical record.
  2. Documented fasting C-peptide concentration ≥0.6 ng/mL (≥0.20 nmol/L) (drawn at least 1 week after treatment for ketosis or acidosis, if applicable).
  3. Documented glutamic acid decarboxylase [GAD] 65 and islet cell antigen [ICA] 512 antibodies below the upper limit of the normal reference ranges.
  4. Has body mass index (BMI) ≥85th percentile, documented at Screening.
  5. Is thought to be able to swallow the tablet containing the study medication.
  6. The participant and/or his/her legal representative (ie, 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 g/dL (<110 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 mL/min based on calculation by central lab using the Cockcroft-Gault approximation 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 (ie, 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:

  1. Must have an HbA1c level of ≥6.5% to <11.0%.
  2. Must not have received an antidiabetic agent other than metformin or insulin within the 12 weeks prior to randomization.
  3. 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.
  4. Has a systolic blood pressure <160 mmHg and a diastolic pressure <100 mmHg. (Antihypertensive medications will be allowed during the study).
  5. 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).
  6. Does not plan to leave the geographic area within 1 calendar year following 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


Contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

  Show 44 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02856113     History of Changes
Other Study ID Numbers: SYR-322_309
U1111-1174-1923 ( Registry Identifier: WHO )
2015-000208-25 ( EudraCT Number )
173300410A0019 ( Registry Identifier: NREC )
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

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:
Alogliptin
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
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