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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02823808
• Other study ID #: KNDP_IIT_2016_01
• Status: Recruiting
• Phase: Phase 4
• First received: July 1, 2016
• Last updated: July 21, 2017
• Start date: July 2017
• Est. completion date: December 2021

Study information

• Verified date: July 2017
• Source: Kyunghee University Medical Center
• Contact: Jeong-taek Woo
• Phone: 822-958-8200
• Email: jtwoomd[@]khmc.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Kyunghee University Medical Center	Seoul

Sponsors (9)

Lead Sponsor	Collaborator
Kyunghee University Medical Center	Ajou University School of Medicine, Bucheon St. Mary's Hospital, Inha University Hospital, Kangbuk Samsung Hospital, Korea University Guro Hospital, Kyung Hee University Hospital at Gangdong, Seoul Medical Center, Takeda

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative treatment failure (HbA1c=7.0%) rate for glycemic control		104 weeks from randomization
Secondary	Change in HbA1c		104 weeks from randomization
Secondary	Change in Fasting Blood Sugar		104 weeks from randomization
Secondary	Change in Glycoalbumin		104 weeks from randomization
Secondary	Change in insulin sensitivity (HOMA2%S)		104 weeks from randomization
Secondary	Change in insulin sensitivity (HOMA2%B)		104 weeks from randomization
Secondary	Change in proinsulin		104 weeks from randomization
Secondary	Change in glucagon		104 weeks from randomization