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PharmacokineticsPhase 1NCT01496443

TAK-875 Glimepiride Drug-Interaction Study

A Phase 1 study testing TAK-875 and Glimepiride in people with Pharmacokinetics, run by Takeda at 1 site 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 pharmacokinetics and safety of TAK-875, once daily (QD), with and without glimepiride in participants with type 2 diabetes mellitus (T2DM). Read more about this study

Who is it for?
Ages 18 to 68 years
Conditions the study is for
Pharmacokinetics
What is being tested?
TAK-875 and Glimepiride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
Jan 2012to May 2012
Phase
Phase 1
Are there results?
None posted in the registry

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 18 to 68 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  • The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  • The participant is a male or female with T2DM who is newly diagnosed, managed with diet and exercise alone, or taking up to 2 oral antidiabetic agents (except insulin and thiazolidinediones (TZDs)) and willing to discontinue the antidiabetic medications 2 weeks prior to enrollment.
  • The participant is aged 18 to 68 years, inclusive, at the time of informed consent and on Day 1.
  • The participant weighs at least 50 kg (110 lb) and has a body mass index (BMI) between 18.0 and 40.0 kg/m2, inclusive at Screening.
  • A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.
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  • A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.
  • The participant has an fasting serum glucose (FPG) >126 mg/dL and <260 mg/dL if not on any diabetic medication, or <220 mg/dL if on any single antidiabetic agent, or < 200 mg/dL if on any combination of 2 oral antidiabetic agents at Screening.
  • The participant has a fasting C-peptide concentration ≥0.8 ng/mL at Screening.
  • The participant has not received treatment with weight-loss drugs within the 3 months prior to Screening.
  • The participant has a systolic blood pressure ≤160 mmHg and a diastolic blood pressure of ≤100 mmHg at Screening and at Check-in (Day -1).
  • The participant met one of the following glycated hemoglobin (HbA1c) criteria (diagnosis must be based on current American Diabetes Association (ADA) criteria) at Screening:
  • Participant who is treatment naïve should have an HbA1c concentration ≥6.5% and ≤10.0%.
  • Participant who is on a single antidiabetic agent (stable dose for at least 28 days) should have an HbA1c ≥6% and ≤9.5%.
  • Participant who is on a combination of up to 2 antidiabetic agents (stable doses for at least 28 days) should have an HbA1c ≥6% and ≤9.0%.
  • The participant has negative test results at Screening and Check-in (Day -1) for selected substances of abuse including alcohol and cotinine.
  • The participant has Screening and Check-in (Day -1) clinical laboratory evaluations (including fasting clinical chemistry, hematology, and complete urinalysis [excluding glucose results]) within the reference range for the testing laboratory, unless the investigator deems the out-of-range results to be not clinically significant.
  • The participant is willing to refrain from strenuous exercise from 72 hours before Check-in (Day -1) and throughout study.
  • The participant is considered by the investigator to be in good health (other than being diabetic) as determined during the medical history review, physical examination findings, electrocardiogram (ECG) and vital sign results, and clinical laboratory evaluations.
  • The participant has a normal creatinine clearance of >60 mL/min using the Cockcroft-Gault formula at Screening and Check-in (Day -1).

Who cannot join

  • The participant is participating in another investigational study or has taken any investigational drug within 30 days prior to Check-in (Day -1).
  • The participant has received TAK-875 in a previous clinical study.
  • The participant's QTcF (Fridericia's correction) is >450 msec (for both male and female participants) at Screening or at Check-in (Day -1) as read on the printout of the ECG produced by the ECG equipment or manually calculated and then evaluated by the investigator.
  • The participant has a resting pulse or heart rate <45 bpm or >100 bpm at Screening or Check-in (Day -1).
  • The participant is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
  • The participant is on any insulin or TZD treatment.
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  • Participant has a known hypersensitivity to any component of the formulation of TAK-875 or glimepiride (see Package Insert).
  • The participant has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
  • The participant has a history of proteinuria >300 mg/day on a 12- or 24-hour urine collection or an albumin/creatinine ratio >300 μg/mg at Screening. If elevated, the participant may be rescreened within 1 week, and may be included in study with agreement between Principal Investigator and the TGRD Medical Monitor.
  • The participant has a history of "severe" hypoglycemia (as defined in Section 7.5.1) within 4 weeks prior to Screening.
  • The participant has a history of any clinically significant retinopathy, which is defined as more than moderate nonproliferative diabetic retinopathy or any stage of proliferative diabetic retinopathy or any history of laser-treated retinopathy.
  • The participant has a history of treated or clinically significant peripheral or autonomic neuropathy.
  • The participant has a history of ulcerative colitis or Crohn's disease, or has undergone gastric resection.
  • The participant has a history of a psychiatric disorder that will affect the participant's ability to participate in the study.
  • The participant has a history of angioedema.
  • The participant had an acute, clinically significant illness within 30 days prior to Check-in (Day -1), or any other condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study.
  • The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
  • Participant has taken any excluded medication, supplements or food products.
  • If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
  • If male, the participant intends to donate sperm during the course of this study or for 30 days after the last dose of study drug.
  • The participant has a history of cardiac arrhythmia, systolic dysfunction congestive heart failure, angina, myocardial ischemia or infarction, or stroke within 1 year prior to Screening, or the presence of an abnormal ECG that, in the investigator's opinion, is clinically significant.
  • Participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention [e.g., cholecystectomy]).
  • The participant has a total bilirubin >1.5 mg/dL at Screening or Check-in (Day -1).
  • Participant has abnormal Screening or Check-in (Day -1) laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: ALT and/or Aspartate Aminotransferase (AST) level >2x ULN for the testing laboratory, active liver disease, or jaundice at Screening or Check-in (Day -1).
  • The participant has a history of abdominal surgery (except laparoscopic cholecystectomy or uncomplicated appendectomy), thoracic or nonperipheral vascular surgery within 6 months prior to Check-in (Day -1).
  • Participant has a history of cancer, other than basal cell or Stage 1 squamous carcinoma of the skin that has not been in remission for at least 5 years prior to Day 1.
  • Participant has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), or a known history of human immunodeficiency virus infection at Screening.
  • Participant has used any nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1) or is unwilling to abstain from these products for the duration of the study or has a positive cotinine test result at Screening or Check-in (Day -1).
  • The participant has poor peripheral venous access.
  • The participant is unwilling or unable to comply with the protocol or scheduled appointments.
  • The participant is unable to understand verbal and/or written English or any other language for which a certified translation of the approved informed consent is available.
  • The participant has donated blood or experienced acute blood loss (including plasmapheresis) of >500 mL within 90 days prior to Day 1.
  • Participant has a Screening or Check-in (Day -1) abnormal (clinically significant) ECG. Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature of the principal investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    San Antonio, Texas

Other trials in United States

About this study

Official title: A Phase 1, Single-Blind, Placebo Controlled, Sequential Design Study to Evaluate the Drug Interaction Potential Between Glimepiride and TAK-875 in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to determine the pharmacokinetics and safety of TAK-875, once daily (QD), with and without glimepiride in participants with type 2 diabetes mellitus (T2DM).

Read the detailed description

TAK-875 is being developed at Takeda Global Research and Development, Inc. as an adjunct to diet and exercise to improve glycemic control in participants with T2DM.

This study will determine whether administration of glimepiride alters the pharmacokinetics (PK) of TAK-875, and whether TAK-875 affects the PK of glimepiride.

Being tested
TAK-875 and Glimepiride
Keywords
Drug Therapy

What participants receive

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

  • TAK-875 and GlimepirideDrug

    Also called Amaryl

Study groups in NCT01496443
Study groupRoleWhat they receive
TAK-875 & Glimepiride QDExperimentalTAK-875 50 mg, tablets, orally and glimepiride 2 mg, capsules, orally and glimepiride placebo matching capsules, orally, once daily on dosing days for up to 19 days.
Receives: Drug: TAK-875 and Glimepiride

What is being measured

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

  1. Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter for TAK-875

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

    Measured: Day 17 and Day 18.

  2. Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter for Glimepiride

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

    Measured: Day 1 and Day 18.

  3. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter for TAK-875

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

    Measured: Day 17 and Day 18.

  4. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter for Glimepiride

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

    Measured: Day 1 and Day 18.

  5. AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter for Glimepiride

    (AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).

    Measured: Day 1 and Day 18.

  6. AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity Pharmacokinetic Parameter for Glimepiride

    AUC(0-inf) is measure of area under the plasma concentration-time curve from time 0 to infinity after drug administration.

    Measured: Day 1 and Day 18.

  7. AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter for TAK-875

    AUC(0-24) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 24 hours in this study).

    Measured: Day 17 and Day 18.

Timeline

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

  1. First posted21 Dec 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionMay 2012
  4. Study completionMay 2012

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
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01496443
Sponsor's protocol ID
TAK-875_118
Other IDs
U1111-1126-0128
Status last verified
Sep 2012
First submitted
18 Dec 2011
Last updated
13 Sep 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-875 and Glimepiride in people with Pharmacokinetics, run by Takeda at 1 site 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 20 inclusion and 33 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 13 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Pharmacokinetic Parameter for TAK-875 (time frame: Day 17 and Day 18.). The study lists 7 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 NCT01496443.

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 13 Sep 2012.

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