Comparison of Pioglitazone Versus Glimepiride in Type 2 Diabetes Inadequately Controlled With Metformin Plus Alogliptin
A Phase IV, Multicenter, Randomized, Active Comparator Controlled Study of the Addition of Pioglitazone Compared With Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Alogliptin
1 other identifier
interventional
154
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 type-2-diabetes-mellitus
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 7, 2015
CompletedFirst Posted
Study publicly available on registry
April 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedApril 24, 2015
April 1, 2015
10 months
March 7, 2015
April 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Evidence of efficacy of glycemic control indicated by the mean changes of HbA1c (%) at week 26 from baseline
26 weeks
Secondary Outcomes (3)
Evidence of changes of insulin resistance and secretion at week 26 from baseline
26 weeks
Evidence of changes of Lipid profile at week 26 from baseline
26 weeks
Evidence of efficacy of glycemic control indicated by the mean changes of HbA1c (%) at week 12 from baseline
12 weeks
Study Arms (2)
Pioglitazone
EXPERIMENTALPioglitazone is a Pioglitazone hydrochloride, and white circle-shaped tablet. It is administered once-daily with 15mg, with or without meals. The once-daily administration begins with 15mg, and if need increase, researchers can increase up to 30mg at week 12.
Glimepiride
ACTIVE COMPARATORThe generic name of Glimepiride is Glimepiride, and it is a green snowman-shaped tablet. The once-daily administration begins with 2mg, and if need increase, researchers can increase up to 4mg at week 12.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pusan National University Hospital
Busan, 602-739, South Korea
Related Publications (1)
Kim JM, Kim SS, Kim JH, Kim MK, Kim TN, Lee SH, Lee CW, Park JY, Kim ES, Lee KJ, Choi YS, Kim DK, Kim IJ. Efficacy and Safety of Pioglitazone versus Glimepiride after Metformin and Alogliptin Combination Therapy: A Randomized, Open-Label, Multicenter, Parallel-Controlled Study. Diabetes Metab J. 2020 Feb;44(1):67-77. doi: 10.4093/dmj.2018.0274. Epub 2019 Jul 11.
PMID: 31339011DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
In Joo Kim, MD., PhD.
Pusan National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Internal Medicine
Study Record Dates
First Submitted
March 7, 2015
First Posted
April 24, 2015
Study Start
February 1, 2015
Primary Completion
December 1, 2015
Study Completion
May 1, 2016
Last Updated
April 24, 2015
Record last verified: 2015-04