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

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orient Europharma Co., Ltd.
• Treatments: Mitiglinide

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

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