Glimepiride, Alogliptin and Alogliptin+Pioglitazone Combination

• Status: Active, not recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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 and are changing their medication. They will be assigned to one of the following treatment groups: the glimepiride monotherapy treatment group, the alogliptin monotherapy treatment group, and the alogliptin - pioglitazone combination therapy treatment group

• This trial is a prospective trial which will conduct surveys 6 times over the course of the 6 months in which each treatment group is administered drugs (Week -2, Baseline, Week 4, Week 12, Week 24, follow-up safety survey).

• This trial is a multicenter clinical trial which will be conducted at more than 5 general hospital medical institutions in the vicinity of the capital.

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

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Alogliptin; Glimepiride; Pioglitazone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)