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

Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function After Early Intensive Diabetes Treatment

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes
• Intervention / Treatment: Drug: NESINA ACT TAB. 25/15mg; Drug: AMARYL-M TAB. 2/500mg

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jeong-taek Woo; Phone Number: 822-958-8200; Email: jtwoomd@khmc.or.kr
• Study Contact Backup: Name: Sang Youl Rhee; Phone Number: 822-958-8200; Email: bard95@hanmail.net

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Kyunghee University Medical Center
    • Contact: Sang Youl Rhee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALO+PIO; Group who takes Alogliptin 25mg+Pioglitazone 15mg, once daily.	Drug: NESINA 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.
Active Comparator: GMPD+MET; Group who takes Glimepiride 2mg+Metformin 500mg, once daily.	Drug: AMARYL-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative treatment failure (HbA1c≥7.0%) rate for glycemic control	104 weeks from randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change in insulin sensitivity (HOMA2%B)	104 weeks from randomization
Change in proinsulin	104 weeks from randomization
Change in glucagon	104 weeks from randomization

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center
• Collaborators: Takeda; Korea University Guro Hospital; Ajou University School of Medicine; Kangbuk Samsung Hospital; Kyung Hee University Hospital at Gangdong; Bucheon St. Mary's Hospital; Inha University Hospital; Seoul Medical Center
• Investigators: Principal Investigator: Jeong-taek Woo, Kyung Hee University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 1, 2016
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors; Glimepiride
• Other Study ID Numbers: KNDP_IIT_2016_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No