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Type 2 Diabetes MellitusPhase 4NCT04349696

Pharmacokinetic and Pharmacodynamic Study of Glufast Tablets 10mg(Mitiglinide)

A Phase 4 study testing Mitiglinide in people with Type 2 Diabetes Mellitus and Liver Dysfunction, run by Orient Europharma Co., Ltd. at 2 sites in Taiwan.

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

This clinical trial is designed to assess the effect of hepatic impairment on the pharmacokinetic and pharmacodynamic of glufast tablets 10 mg. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus, Liver Dysfunction
What is being tested?
Mitiglinide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
2 sitesTaiwan
Study dates
11 Feb 2014to Apr 2018
Phase
Phase 4
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects between 20-75 years of age, inclusive.
  • Body mass index (BMI) values within 20-35 kg/m2.
  • Diagnosed as type 2 diabetes mellitus and have fasting plasma glucose (FPG) less than 200 mg/dL at screen visit (for subjects under antidiabetic treatment).
  • Having 2-hour postprandial glucose (PPG) level higher than or equal to 200 mg/dL at screen visit (for subjects who are antidiabetic treatment-naïve).
  • Having fasting plasma glucose (FPG) higher than or equal to 126 mg/dL and less than 200 mg/dL at screen visit (for subjects who are antidiabetic treatment-naïve).
  • Having been treated with dietary and exercise therapy alone or with a stable regimen for diabetes, including mitiglinide, α-glucosidase inhibitors (such as acarbose and QPS Taiwan Protocol #: OEP-P2012-01 Version: 7.0 Confidential Page 19 of 32 miglitol), metformin, sulfonylureas, DPP-IV inhibitors, thiazolidinediones (such as pioglitazone and rosiglitazone), insulin preparations or with oral antidiabetic agents in combination with insulin preparations.
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  • Have signed the written informed consent to participate in the study.
  • For patients with normal hepatic function (Arm 1): characterized as normal hepatic function with laboratory tests, such as AST (SGOT), ALT (SGPT), -GT, alkaline phosphatase, total bilirubin and albumin, within the acceptable range or results with minor deviations determined to be not clinically significant by the investigator.
  • For patients with moderate impaired hepatic function (Arm 2): patients who have been diagnosed as liver cirrhosis and have Child-Pugh system point between 7 and 9 within 3 months prior to screen visit or who have Child-Pugh system point between 7 and 9 during screening period.

Who cannot join

  • Diagnosed as Type 1 (insulin-dependent) diabetes mellitus.
  • Having 1-hour PPG or 2-hour PPG levels > 350 mg/dL at screen visit.
  • History of diabetic ketoacidosis with or without coma.
  • With unstable or rapidly progressive diabetic proliferative retinopathy or rapidly progressive diabetic neuropathy under investigator's judgment.
  • Having clinically significant renal disease or dysfunction (e.g. serum creatinine >1.6 mg/dL) and concurrent anemia.
  • Congestive heart failure (function class III to IV) or myocardial infarction within past 6 months.
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  • Recent history of drug or alcohol addiction or abuse.
  • History of allergic response(s) to mitiglinide or related drugs.
  • Pregnant or lactating women or women of childbearing potential whom were not practicing a reliable form of birth control.
  • Receiving any investigational drug within one month prior to screen visit.
  • Taking high-dose sulfonylureas (e.g. taking doses exceeding 5 mg/day of glibenclamide or 80 mg/day of gliclazide or 4 mg/day of glimepiride or 5 mg/day glipizide).
  • Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
  • Patients with normal hepatic function (Arm 1):
  • A positive test for hepatitis B surface antigen or positive hepatitis C antibody.
  • Presence of liver cirrhosis or liver carcinoma detected by hepatic ultrasound and deemed ineligible in the investigator's judgment.
  • Patients with moderate impaired hepatic function (Arm 2):
  • Having acute liver disease caused by infection or drug toxicity within one month prior to screen visit.
  • History of liver transplantation.
  • Having severe portal hypertension within one month prior to screen visit.
  • Having fluctuating or rapidly deteriorating hepatic function based on clinical signs or laboratory tests during the screening period

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Chiayi Chang Gung Memorial Hospital

    Chiayi City, 61363

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

Official title: A Pharmacokinetic and Pharmacodynamic Study of Glufast Tablets 10 mg (Mitiglinide) in Type 2 Diabetes Mellitus Patients With Normal or Moderate Impaired Hepatic Function

This clinical trial is designed to assess the effect of hepatic impairment on the pharmacokinetic and pharmacodynamic of glufast tablets 10 mg.

Read the detailed description

Mitiglinide calcium hydrate (Glufast Tablets) is an insulinotropic agent of the glinide class with rapid onset and is chemically designated as (+)-monocalcium bis[(2S,3a,7a-cis)-α-benzylhexahydro-γ-oxo-2-isoindolinebutyrate] dihydrate.By transiently increasing insulin secretion, mitiglinide exerts a hypoglycemic effect with rapid onset and short duration of action.This effect results from the inhibitory effect of mitiglinide on the ATP-sensitive potassium (KATP) channel current through binding to sulfonylurea receptor in pancreatic cells.

In an in vitro study, it was confirmed that mitiglinide is metabolized in liver and kidney, and the glucuronide and hydroxyl metabolites are mainly produced by drug metabolizing enzyme,UGT1A9 and 1A3, and by CYP2C9, respectively.Considering that the patient population with T2DM to be targeted appears to have hepatic impairment and the effects of liver dysfunction on pharmacokinetics and pharmacodynamics of mitiglinide are still unknown, this study was designed to investigate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of mitiglinide when administered to T2DM patients with impaired hepatic function.

Being tested
Mitiglinide
Keywords
Type 2 DM, mitiglinide, Pharmacokinetics, Pharmacodynamics, liver dysfunction
Medical subject headings
Diabetes Mellitus, Type 2, Liver Diseases

What participants receive

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

  • MitiglinideDrug

    Also called glufast

    Day 1: one tablet of Mitiglinide 10mg with 240 ml of water approximately 5 mins before breakfast. An indwelling non-heparin catheter will be placed in an antecubital vein of the forearm or direct venipuncture will be adopted for blood sample collection at belowing time point:

    For PK evaluation:

    -30 (Predose), 5, 10, 15, 20, 30 min, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10 hr post dose (a total of 17 samples per subject)

    For PD evaluation:

    -30 (Predose), 15, 30 min, 1.0, 1.5, 2.0, 3.0, 4.0 hours post dose (a total of 8 samples per subject)

Study groups in NCT04349696
Study groupRoleWhat they receive
T2DM with Child-Pugh AActive comparatorAll subjects with T2DM with normal hepatic function received a Mitiglinide Tablets 10 mg. Intervention: Drug: Mitiglinide Tablets 10 mg
Receives: Drug: Mitiglinide
T2DM with Child-Pugh BExperimentalAll subjects with T2DM with moderate impaired hepatic function received a MitiglinideTablets 10 mg. Intervention:Drug: Mitiglinide Tablets 10 mg
Receives: Drug: Mitiglinide

What is being measured

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

  1. Peak concentration (Cmax)

    Pharmacokinetic of mitiglinide

    Measured: 1 day

  2. Time to reach peak concentration (Tmax)

    Pharmacokinetic of mitiglinide

    Measured: 1day

  3. Area under plasma concentration -time curve from time zero to time of last quantifiable concentration (AUC0-t)

    Pharmacokinetic of mitiglinide

    Measured: 1 day

  4. Area under the plasma concentration-time curve from time zero to infinity of mitiglinide

    Pharmacokinetic of mitiglinide

    Measured: 1 day

  5. The elimination rate constant

    Pharmacokinetic of mitiglinide

    Measured: 1 day

  6. Volume of distribution (Vd/F)

    Pharmacokinetic of mitiglinide

    Measured: 1 day

  7. Terminal elimination half-life (T1/2)

    Pharmacokinetic of mitiglinide

    Measured: 1 day

  8. Total body clearance (CL/F)

    Pharmacokinetic of mitiglinide

    Measured: 1 day

  9. Ratio of AUC0-t to AUC0-infinity

    Pharmacokinetic of mitiglinide

    Measured: 1 day

  10. Area under the blood glucose concentration-time curve from time zero to time of last blood sample (AUC0-t,GLU)

    Pharmacokinetic of mitiglinide

    Measured: 1 day

  11. Area under the blood glucose concentration(change from baseline)-time curve from time zero to time of last blood sample (ΔAUC0-t,GLU)

    Pharmacokinetic of mitiglinide

    Measured: 1 day

  12. Blood glucose concentration change from baseline at 2 hours after drug administration

    Pharmacokinetic of mitiglinide

    Measured: 1 day

Timeline

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

  1. First posted16 Apr 2020
  2. Study start11 Feb 2014
  3. Primary completionApr 2018
  4. Study completionApr 2018

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04349696
Sponsor's protocol ID
OEP-P2012-01
Status last verified
Apr 2021
First submitted
3 Mar 2020
Last updated
30 Apr 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mitiglinide in people with Type 2 Diabetes Mellitus and Liver Dysfunction, run by Orient Europharma Co., Ltd. at 2 sites in Taiwan.

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 9 inclusion and 20 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 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Peak concentration (Cmax) (time frame: 1 day). The study lists 12 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 NCT04349696.

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 30 Apr 2021.

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