Status:
COMPLETED
Pharmacokinetic and Pharmacodynamic Study of Glufast Tablets 10mg(Mitiglinide)
Lead Sponsor:
Orient Europharma Co., Ltd.
Conditions:
Type 2 Diabetes Mellitus
Liver Dysfunction
Eligibility:
All Genders
20-75 years
Phase:
PHASE4
Brief Summary
This clinical trial is designed to assess the effect of hepatic impairment on the pharmacokinetic and pharmacodynamic of glufast tablets 10 mg.
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-o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04349696
Start Date
February 11 2014
End Date
April 1 2018
Last Update
April 30 2021
Active Locations (2)
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1
Chiayi Chang Gung Memorial Hospital
Chiayi City, Taiwan, 61363
2
Taipei Veterans General Hospital
Taipei, Taiwan, 11217