TAK-875 Glimepiride Drug-Interaction Study

NCT01496443 | Completed Phase 1

• 2 other identifiers: TAK-875_118U1111-1126-0128
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pharmacokinetics

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (7)

• 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.

  Day 17 and Day 18.

• 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.

  Day 1 and Day 18.

• 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.

  Day 17 and Day 18.

• 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

  Day 1 and Day 18.

• 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\[0-tlqc\]).

  Day 1 and Day 18.

• 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.

  Day 1 and Day 18.

• 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).

  Day 17 and Day 18.

Study Arms (1)

TAK-875 & Glimepiride QD

EXPERIMENTAL

TAK-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.

Drug: TAK-875 and Glimepiride

Interventions

TAK-875 and Glimepiride DRUG

Also known as: Amaryl

TAK-875 & Glimepiride QD

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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%.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Interventions

TAK-875; glimepiride

Study Officials

• Senior Medical Director, Clinical Science

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2011
• First Posted: December 21, 2011
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 13, 2012

Record last verified: 2012-09

Locations

US (1)