Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function

Phase 4

• Conditions: Diabetes
• Interventions: Drug: NESINA ACT TAB. 25/15mg; Drug: AMARYL-M TAB. 2/500mg

• Registration Number: NCT02823808
• Lead Sponsor: Kyunghee University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-01
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-06
• Status Verified: 2017-07
• Study Start: 2017-07
• Last Update Submitted: 2017-07-21
• Last Update Posted: 2017-07-25
• Primary Completion: 2021-07
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALO+PIO	NESINA ACT TAB. 25/15mg	Group who takes Alogliptin 25mg+Pioglitazone 15mg, once daily.
GMPD+MET	AMARYL-M TAB. 2/500mg	Group who takes Glimepiride 2mg+Metformin 500mg, once daily.

Primary Outcome Measures

Name	Time	Method
Cumulative treatment failure (HbA1c≥7.0%) rate for glycemic control	104 weeks from randomization

Secondary Outcome Measures

Name	Time	Method
Change in insulin sensitivity (HOMA2%B)	104 weeks from randomization
Change in proinsulin	104 weeks from randomization
Change in glucagon	104 weeks from randomization
Change in HbA1c	104 weeks from randomization
Change in Fasting Blood Sugar	104 weeks from randomization
Change in Glycoalbumin	104 weeks from randomization
Change in insulin sensitivity (HOMA2%S)	104 weeks from randomization

Trial Locations

Locations (1)

Kyunghee University Medical Center; 🇰🇷 Seoul, Korea, Republic of