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

NCT04349696 | Completed Phase 4

• 1 other identifier: OEP-P2012-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus; Liver Dysfunction

Keywords

Type 2 DM; mitiglinide; Pharmacokinetics; Pharmacodynamics; liver dysfunction

Outcome Measures

Primary Outcomes (12)

• Peak concentration (Cmax)

  Pharmacokinetic of mitiglinide

  1 day

• Time to reach peak concentration (Tmax)

  Pharmacokinetic of mitiglinide

  1day

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

  Pharmacokinetic of mitiglinide

  1 day

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

  Pharmacokinetic of mitiglinide

  1 day

• The elimination rate constant

  Pharmacokinetic of mitiglinide

  1 day

• Volume of distribution (Vd/F)

  Pharmacokinetic of mitiglinide

  1 day

• Terminal elimination half-life (T1/2)

  Pharmacokinetic of mitiglinide

  1 day

• Total body clearance (CL/F)

  Pharmacokinetic of mitiglinide

  1 day

• Ratio of AUC0-t to AUC0-infinity

  Pharmacokinetic of mitiglinide

  1 day

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

  Pharmacokinetic of mitiglinide

  1 day

• 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

  1 day

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

  Pharmacokinetic of mitiglinide

  1 day

Study Arms (2)

T2DM with Child-Pugh A

ACTIVE COMPARATOR

All subjects with T2DM with normal hepatic function received a Mitiglinide Tablets 10 mg. Intervention: Drug: Mitiglinide Tablets 10 mg

Drug: Mitiglinide

T2DM with Child-Pugh B

EXPERIMENTAL

All subjects with T2DM with moderate impaired hepatic function received a MitiglinideTablets 10 mg. Intervention:Drug: Mitiglinide Tablets 10 mg

Drug: Mitiglinide

Interventions

Mitiglinide DRUG

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)

Also known as: glufast

T2DM with Child-Pugh A; T2DM with Child-Pugh B

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Orient Europharma Co., Ltd.: lead

Study Sites (2)

Chiayi Chang Gung Memorial Hospital

Chiayi City, 61363, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Liver Diseases

Interventions

mitiglinide

Condition Hierarchy (Ancestors)

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

Study Officials

• Yi-Hsiang Huang, Ph.D

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

• Wei-Ming Chen, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: April 16, 2020
• Study Start: February 11, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)