Pharmacokinetics, Pharmacodynamics, and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus

NCT00957268 | Completed Phase 1 Results

• 3 other identifiers: SYR-322_1042009-011221-13U1111-1111-7810
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine the pharmacokinetic and safety profile of alogliptin in children, adolescents, and adults with type 2 diabetes mellitus.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes mellitus; Non-insulin dependent diabetes mellitus; Drug therapy; Pediatrics

Outcome Measures

Primary Outcomes (3)

• Cmax: Maximum Observed Plasma Concentration for Alogliptin

  Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

  1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alogliptin

  Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.

  1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose

• AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alogliptin

  AUC(0-inf) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau\]), where tau is the length of the dosing interval in this study).

  1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose

Secondary Outcomes (8)

• Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition

  1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose

• Maximum Observed Effect (Emax) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition

  1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose

• Time to Reach the Maximum Observed Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition

  1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose

• Observed Effect at 24 Hours Post-dose (E24) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition

  1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose

• Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration

  1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose

Study Arms (5)

Alogliptin 12.5 mg (age 10 to < 14 years)

EXPERIMENTAL

Alogliptin 12.5 mg, tablets, orally, 1 dose only.

Drug: Alogliptin

Alogliptin 25 mg (age 10 to < 14 years)

EXPERIMENTAL

Alogliptin 25 mg, tablets, orally, 1 dose only.

Drug: Alogliptin

Alogliptin 12.5 mg (age 14 to < 18 years)

EXPERIMENTAL

Alogliptin 12.5 mg, tablets, orally, 1 dose only.

Drug: Alogliptin

Alogliptin 25 mg (age 14 to < 18 years)

EXPERIMENTAL

Alogliptin 25 mg, tablets, orally, 1 dose only.

Drug: Alogliptin

Alogliptin 25 mg (age 18 to 65 years)

EXPERIMENTAL

Alogliptin 25 mg, tablets, orally, 1 dose only.

Drug: Alogliptin

Interventions

Alogliptin DRUG

Alogliptin tablets

Also known as: SYR-322

Alogliptin 12.5 mg (age 10 to < 14 years); Alogliptin 12.5 mg (age 14 to < 18 years); Alogliptin 25 mg (age 10 to < 14 years); Alogliptin 25 mg (age 14 to < 18 years); Alogliptin 25 mg (age 18 to 65 years)

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant was male or female between 10 and 17 years of age.
• Participant or parent or legal guardian was capable of understanding and complying with the protocol requirements.
• Participant was capable of understanding an informed consent form (ICF) or assenting to participate. The parent or legal guardian of the participant must have been able to understand and sign an ICF prior to the initiation of any study procedures.
• Participant weighed at least 36 kg (79 pounds) and had a Screening body mass index (BMI) of at least 18 kg/m\^2.
• Participants had a diagnosis of type 2 diabetes mellitus (T2DM) (non-insulin dependent) based on diagnostic criteria of the American Diabetes Association (ADA). Criteria included:
• Fasting plasma glucose level of ≥ 126 mg/dL where fasting is defined as no caloric intake for at least 8 hours, or
• hour plasma glucose level of ≥ 200 mg/dL during an oral glucose tolerance test, or
• random plasma glucose level of ≥ 200 mg/dL, or
• glycated hemoglobin (HbA1c) ≥ 6.5%.
• Diagnosis could have been historical (documented), or participants could have been diagnosed for this study.
• Participants had a fasting serum C-peptide concentration ≥ 0.8 ng/mL (≥ 0.26 nmol/L) at the Screening Visit only.
• Participants may have been taking concomitant metformin if the dose was stable for at least 30 days prior to Day 1 (day of first dosing).
• Participant was male or female, and between 18 and 65 years of age, inclusive for gender and race matched adult participants with T2DM only.
• Participant was capable of understanding and complying with protocol requirements and was willing to sign the ICF prior to the initiation of any study procedures for gender and race matched adult participants with T2DM only.
• Participant weighed at least 50 kg (110 pounds) and had a Screening BMI between 23 kg/m\^2 and 45 kg/m\^2 (except for Asian or Asian-descendant participants for whom the range was between 20 kg/m\^2 and 35 kg/m\^2), inclusive for gender and race matched T2DM adult participants only.

You may not qualify if:

• Participant was currently participating in another investigational study or took an investigational drug within 30 days prior to Day 1.
• Participant received alogliptin previously.
• Participant was a study site employee, or was an immediate family member (ie, spouse, parent, child, or sibling) of a study site employee involved in conduct of this study.
• Participant received or donated blood or blood products within 30 days prior to Screening or planned to donate blood during the study.
• Participant had a known hypersensitivity to alogliptin or related compounds.
• Participant had a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as consumption of more than 4 alcoholic drinks per day) within 1 year prior to study Day 1.
• Participant had an acute, clinically significant illness (excluding T2DM) within 30 days prior to study Day 1.
• Participant had any other condition or prior therapy that, in the opinion of the investigator, would have made the participant unsuitable for the study.
• Participant had a history or clinical manifestations of significant metabolic (excluding T2DM), hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, musculoskeletal, or psychiatric disorder.
• Participant had a hemoglobin value \< 12 g/dL.
• Participant had a systolic blood pressure \> 140 mm Hg or had a diastolic blood pressure \> 90 mmHg at Screening or Check-in (Day -1).
• Adult participant had an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level greater than 2 times the upper limit of normal (ULN), active liver disease, or jaundice at the Screening Visit or on Check-in (Day -1).
• Pediatric participant had an ALT or AST level greater than 1.5 times the ULN at the Screening Visit or on Check-in (Day -1).
• Participant had a serum creatinine level \> 1.5 mg/dL.
• Participant had a creatinine clearance (CrCl) \< 50 mL/min (normalized to body surface area of 1.73 m\^2).

Sponsors & Collaborators

• Takeda: lead

Study Sites (7)

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Pineallas Park, Florida, United States

Location

Unknown Facility

Louisville, Kentucky, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

alogliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• VP Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: August 12, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 29, 2015
• Results First Posted: January 29, 2015

Record last verified: 2015-01

Locations

US (7)