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Diabetes Mellitus, Type 2Phase 1NCT00957268

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

A Phase 1 study testing Alogliptin in people with Diabetes Mellitus, Type 2, run by Takeda at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Alogliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
7 sitesUnited States
Study dates
Sep 2009to Nov 2013
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • Participants had a diagnosis of T2DM (non-insulin dependent) based on diagnostic criteria of the 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
  • 2-hour plasma glucose level of ≥ 200 mg/dL during an oral glucose tolerance test, or
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  • random plasma glucose level of ≥ 200 mg/dL, or
  • HbA1c ≥ 6.5%.
  • Diagnosis could have been historical (documented) or participants could have been diagnosed for this study.
  • Participants may have been taking concomitant metformin if the dose was stable for at least 30 days prior to Day 1.
  • Participants may have been taking statin or antihypertensive drugs if the dose was stable for at least 30 days prior to Day 1.
  • Inclusion criteria for all participants (Groups 1, 2, and 3):
  • Female participants of childbearing potential and male participants who were sexually active agreed to routinely use adequate contraception from Screening until 30 days after receiving the dose of study drug. NOTE: Women not of childbearing potential were defined as those who were surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation) or who were postmenopausal (defined as at least 45 years of age and 1 year since last regular menses).
  • Participant had a negative urine test result for selected substances of abuse (including alcohol and cotinine) at Screening and Check-in (Day -1).
  • Participant had clinical chemistry, hematology, and complete urinalysis (fasted for at least 8 hours) results within the reference range for the testing laboratory (except results associated with T2DM) unless the out-of-range results were deemed not clinically meaningful by the investigator or sponsor.
  • Participant had a negative test result for hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (anti-HCV), and no known history of human immunodeficiency virus.

Who cannot join

  • 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.
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  • 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).
  • Participant had a history of abdominal surgery (except laparoscopic cholecystectomy or uncomplicated appendectomy) or thoracic or nonperipheral vascular surgery within 6 months prior to Day 1.
  • Participant had a history or presence of a clinically significant abnormal 12-lead electrocardiogram (ECG) result as determined by the investigator or Takeda at Screening or Check-in (Day -1).
  • Participant had a history of cancer, other than basal cell carcinoma or Stage I squamous cell carcinoma of the skin that had not been in remission for at least 5 years prior to the first dose of study drug.
  • If female, participant was pregnant or lactating or intending to become pregnant before, during, or within 30 days after receiving study drug.
  • If male, participant intended to impregnate others during the study or for 30 days after receiving study drug.
  • Participant consumed or was unable to abstain from consumption of products containing alcohol, caffeine, or xanthine, and food or beverages containing grapefruit juice or Seville-type oranges within 72 hours prior to study Day 1 and for the duration of the study.
  • Participant used any tobacco (ie, nicotine) products (including but not limited to cigarettes, pipe, cigar, chewing tobacco, nicotine patch, or nicotine gum) within 6 weeks prior to study Day 1, and was unwilling to abstain from these products for the duration of the study.
  • Participant used any nutraceutical preparations within 28 days prior to study Day 1.
  • Participant was currently taking ketoconazole, fluconazole, gemfibrozil, rifampin, or carbamazepine or taken within 28 days prior to Check-in (Day -1).
  • Participant had poor peripheral venous access.
  • Participant had a medical history of clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes or secondary forms of diabetes, including maturity-onset diabetes of the young (MODY).

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Study site

    Durham, North Carolina

  • Study site

    Louisville, Kentucky

  • Study site

    Memphis, Tennessee

  • Study site

    Miami, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pineallas Park, Florida

  • Study site

    San Antonio, Texas

Other trials in United States

About this study

Official title: A Comparative, Randomized, Open-Label, Multi-Center, Single Dose Pharmacokinetic, Pharmacodynamic and Safety Study of Alogliptin (12.5 mg and 25 mg) Between Children, Adolescents, and Adults With Type 2 (Non-Insulin Dependent) Diabetes Mellitus

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.

Read the detailed description

Alogliptin is a selective, orally available inhibitor of dipeptidyl peptidase-4 being developed by Takeda Global Research \& Development as a treatment for type 2 diabetes mellitus. Inhibition of dipeptidyl peptidase-4 (DPP-4) prolongs the action of 2 important incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). These hormones are responsible for increasing insulin synthesis, regulating β-cell proliferation, inhibiting gastric emptying, and inhibiting glucagon secretion.

To date, alogliptin has not been studied in participants less than 18 years of age. As with adults, there is growing evidence of an increase in the prevalence of type 2 diabetes mellitus in children and adolescents.

This study is designed to determine the pharmacokinetic, pharmacodynamic, and safety profiles of alogliptin in children and adolescents with type 2 diabetes mellitus. These profiles will be compared with those of similarly matched adult participants with type 2 diabetes mellitus. Pharmacokinetic, pharmacodynamics, and safety endpoints will be analyzed.

Being tested
Alogliptin
Keywords
Type 2 diabetes mellitus, Non-insulin dependent diabetes mellitus, Drug therapy, Pediatrics
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlogliptinDrug

    Also called SYR-322

    Alogliptin tablets

Study groups in NCT00957268
Study groupRoleWhat they receive
Alogliptin 12.5 mg (age 10 to < 14 years)ExperimentalAlogliptin 12.5 mg, tablets, orally, 1 dose only.
Receives: Drug: Alogliptin
Alogliptin 25 mg (age 10 to < 14 years)ExperimentalAlogliptin 25 mg, tablets, orally, 1 dose only.
Receives: Drug: Alogliptin
Alogliptin 12.5 mg (age 14 to < 18 years)ExperimentalAlogliptin 12.5 mg, tablets, orally, 1 dose only.
Receives: Drug: Alogliptin
Alogliptin 25 mg (age 14 to < 18 years)ExperimentalAlogliptin 25 mg, tablets, orally, 1 dose only.
Receives: Drug: Alogliptin
Alogliptin 25 mg (age 18 to 65 years)ExperimentalAlogliptin 25 mg, tablets, orally, 1 dose only.
Receives: Drug: Alogliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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).

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

Secondary outcomes (8)

  1. 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

    The 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 was determined from the inhibition-time curve.

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

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

    The maximum observed effect (Emax) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.

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

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

    The time to reach the maximum observed effect of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.

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

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

    The observed effect at 24 hours post-dose (E24) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.

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

  5. 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

    The area under the plasma effect-time curve from time 0 to 24 hours post-dose (AUEC[0-24]) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.

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

  6. Maximum Observed Effect (Emax) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration

    The maximum observed effect (Emax) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.

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

  7. Time to Reach the Maximum Observed Effect of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration

    The time to reach the maximum observed effect of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.

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

  8. Observed Effect at 24 Hours Post-dose (E24) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration

    The observed effect at 24 hours post-dose (E24) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00957268
Sponsor's protocol ID
SYR-322_104
Other IDs
2009-011221-13, U1111-1111-7810, 2009
Status last verified
Jan 2015
First submitted
6 Aug 2009
Last updated
29 Jan 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Alogliptin in people with Diabetes Mellitus, Type 2, run by Takeda at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax: Maximum Observed Plasma Concentration for Alogliptin (time frame: 1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00957268.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2015.

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