Diabetes
Conditions
Brief summary
All subjects will be randomized as Alo/Pio combo group (intervention) or Glim/Met combo group (control) after intensive COAD treatment based on identical protocol. * All subject will be managed with once daily, fixed dose, single tablet treatment based on the study protocol, and followed-up for 104 weeks. * Any group of subjects who fail to reach glycemic target with single tablet treatment, subject will be treated with rescue medication and stopped regular observation.
Interventions
DRUGNESINA ACT TAB. 25/15mg
Alogliptin/Pioglitazone 25/15mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.
DRUGAMARYL-M TAB. 2/500mg
Glymepiride/Metformin 2/500mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.
Sponsors
Takeda
Kyung Hee University Hospital at Gangdong
Bucheon St. Mary's Hospital
Korea University Guro Hospital
Ajou University School of Medicine
Inha University Hospital
Kangbuk Samsung Hospital
Seoul Medical Center
Kyunghee University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
26 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 Diabetes Mellitus patients * Patient who had been diagnosed within the previous 12 months with HbA1c levels of 8.0-12.0%, did not have a medical history related to diabetes, and did not display proliferative retinopathy
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 * Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative treatment failure (HbA1c≥7.0%) rate for glycemic control | 104 weeks from randomization |
Secondary
| Measure | Time frame |
|---|---|
| Change in insulin sensitivity (HOMA2%S) | 104 weeks from randomization |
| Change in insulin sensitivity (HOMA2%B) | 104 weeks from randomization |
| Change in proinsulin | 104 weeks from randomization |
| Change in Glycoalbumin | 104 weeks from randomization |
| Change in Fasting Blood Sugar | 104 weeks from randomization |
| Change in glucagon | 104 weeks from randomization |
| Change in HbA1c | 104 weeks from randomization |
Countries
South Korea
Contacts
Primary ContactJeong-taek Woo
Backup ContactSang Youl Rhee
Outcome results
None listed