Status:
UNKNOWN
Glimepiride, Alogliptin and Alogliptin+Pioglitazone Combination
Lead Sponsor:
Seoul National University Hospital
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19-80 years
Phase:
PHASE4
Brief Summary
* This trial is a three-armed, open label, random assignment trial. * The research subjects are patients who are first starting their treatment or patients who have failed with the metformin treatment...
Detailed Description
* The research subjects selected for this trial will patients among those who have given their approval to participate in the trial and who are first starting their treatment or who intend to alter th...
Eligibility Criteria
Inclusion
- Subjects selected for this trial will be male and female outpatients 19 - 80 years of age (by date of birth) with type 2 diabetes and with HbA1c levels of 7.5%≤HbA1c≤10%.
- Patient's body mass index must be greater than 18 kg/m2.
- Subjects selected for the trial are patients who are starting treatment for the first time or who have failed with more than 8 weeks of treatment with 1,000 mg or the maximum tolerance dose (MTD) of metformin and want to change their medication.
Exclusion
- If weight loss pills were used in the last 3 months, or hypoglycemic agents or lipid lowering agents used in a clinical trial (not including statins or ezetimibe) were used in the last 3 months.
- If the subject received systemic corticosteroid treatment or there was a change in the dosage of thyroid hormones in the 6 weeks prior to the study.
- If insulin was used within the 3 months prior to screening.
- If the patient's C-peptide level is less than 0.6 ng/mL.
- If an allergy or a hypersensitivity reaction to the target drug or its ingredients occurs.
- Additional criteria for exclusion are listed below;
- A medical history of type 1 diabetes; acute metabolic complications of diabetes within the past 6 months (e.g., ketoacidosis or a hyperosmolar state (coma or precoma))
- Hematological disorder
- A medical history of angioedema caused by angiotensin converting enzyme inhibitors or angiotensin receptor blockers or a medical history of treatment for diabetic gastroparesis
- If there are clear symptoms of hypothyroidism or hyperthyroidism in the opinion of the investigator.
- Myocardial infarction or percutaneous coronary intervention (stent nephrostomy or balloon nephrostomy) within the past 6 months
- Serious heart failure or a medical history of heart failure (NYHA Class III or IV heart failure)
- Heart failure, moderate to severe kidney injury (creatinine clearance of \<50 mL/min prior to screening)
- Patients with chronic hepatitis, or hepatitis B or C (not including healthy carriers of hepatitis B) or a patient with liver disease (defined as cases in which the alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or serum total bilirubin level is higher than 2.5 times the ULN)
- Hereditary complications, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (restricted to drugs including lactase)
- Cardiovascular disease or myocardial infarction; or a percutaneous transluminal coronary angioplasty or coronary artery stent nephrostomy within the past 6 months
- A serious cerebrovascular accident, stroke, or transient ischemic attack within the past 6 months
- Laser treatment for diabetic proliferative retinopathy
- A medical history of alcohol or drug abuse in the past 3 months
- A medical history of cancer in which remission could not be achieved within 5 years
- A medical history of bladder cancer or active bladder cancer
- Uninvestigated macroscopic hematuria
- Has experienced major surgery
- Breast feeding women, pregnant women, or premenopausal for whom pregnancy is possible are not suitable for participation in this trial
- External injury, acute infection, existence of or medical history of other chronic illness
- Criteria for exclusion based on laboratory test results are as listed below.
- A fasting blood glucose (FPG) level of \>239.6 mg/dL
- Systolic or diastolic blood pressure of \>160 mmHg or \>100 mmHg respectively
- A serum creatinine level of 1.5 mg/dL for men or 1.4 mg/dL for women
- An albumin/creatinine ratio of 2,000 mg/g
- A fasting triglyceride level of \> 5.1 mmol/l (452 mg/dL)
Key Trial Info
Start Date :
December 31 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04470310
Start Date
December 31 2015
End Date
August 31 2021
Last Update
October 22 2020
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