Comparison of Pioglitazone Versus Glimepiride in Type 2 Diabetes Inadequately Controlled With Metformin Plus Alogliptin

• Status: Unknown status
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the treatment effect at week 26 between the two groups, sulfonylurea (SU, glimepiride) administration and thiazolidinedione (TZD, Pioglitazone) administration, as the third-order drug among patients whose treatment is not sufficient after the combined administration of Metformin and Alogliptin.

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

Details

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

Criteria

Inclusion Criteria:

• Subjects included in the study are regular type 2 diabetes outpatients of male and female with a level of 7.5%≤HbA1c<10%, despite metformin and alogliptin treatments more than 3months, between 19 and 80 years old.

• Patients had to have a body weight of at least 55 kg and or a body mass index of 22-35 kg/m2

Exclusion Criteria:

• the use of weight-lowering drugs, any investigational blood-glucose or lipid-lowering agent (other than statins or ezetimibe) within the past 3 months

• previous treatment with systemic corticosteroids or a change in dosage of thyroid hormones in the previous 6 weeks

• the use of insulin within the 3 months prior to screening

• allergy or hypersensitivity to target medication or any of its components

• history of type 1 diabetes; acute metabolic complications of diabetes (e.g. ketoacidosis or hyperosmolar state (coma or precoma)) within the preceding 6 months

• haematological disorders

• history of angioedema with angiotensin converting enzyme inhibitors or angiotensin receptor blockers, or treated diabetic gastric paresis

• renal failure, moderate or severe renal impairment (creatinine clearance<50 ㎖/min; or estimated glomerular filtration rate<50 ㎖/min/1.73㎡) before screening

• Serious heart failure or prior history of heart failure(NYHA Class Ⅲ or Ⅳ heart failure.

• impaired hepatic function (defined as elevated serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase 2.5-fold the upper limit of the normal range [ULN] or elevated serum total bilirubin levels 2.5-fold ULN)

• hereditary complications (limited to lactose containing medicines) such as galactose intolerance, deficiency of Lapp lactase, glucose-galactose malabsorption syndrome, etc

• cardiovascular disease, myocardial infarction, or in the previous 6 months; coronary angioplasty, coronary stent placement

• serious cerebrovascular, stroke, transient ischemic attack in the previous 6 months

• laser treatment for proliferative diabetic retinopathy

• history of alcohol or drug abuse in the previous 3 months

• history of all of cancers not in remission for 5 years

• Active bladder cancer

• experience of a major operation

• premenopausal women who were nursing or pregnant were also ineligible for trial participation

• external injury, acute infections, a history/presence of any other severe disease, or severe trauma

• fasting plasma glucose (FPG) level of >239.6mg/dL

• systolic or diastolic blood pressure >160 mmHg or >100 mmHg, respectively

• serum creatinine level of >1.5mg/dL for men or 1.3mg/dL for women

• fasting cholesterol >250mg/dL

• thyroid-stimulating hormone higher than the upper limit of normal

• hemoglobin level is below 12 g/dL for men and below 10 g/dL for women

• fasting triglyceride levels> 5.1 mmol/l (452 mg/dL)