An Extension Study of PEAK Trial

Diabetes Mellitus, Type 2 Clinical Trial

— PEAK-E  

Official title:

An Extension Study of Protocol ALO-IIT(PEAK Study) to Examine the Long-term Efficacy and Safety of Metformin + Alogliptin + Pioglitazone Triple Combination Therapy in the Korean Type 2 Diabetes Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02763007
• Other study ID #: PEAK-E
• Status: Terminated
• Phase: Phase 4
• Start date: May 18, 2016
• Est. completion date: February 28, 2019

Study information

• Verified date: June 2019
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Double blind, three arm, comparative intervention trial for 24 weeks(PEAK study) with open label extension trial for 28 weeks followed by 2 year observational study.

Description:

PEAK trial is now undergoing (Multicenter, randomized, double blind, three-arm parallel group study to evaluate efficacy and safety of Alogliptin and Pioglitazone combination therapy on glucose control in type 2 diabetes subjects who have inadequate control with Metformin monotherapy in Korea, Takeda No. ALO-IIT-012).

Duration of combination treatment is 24 week in the PEAK trial. Long-term efficacy and safety of alogliptin + pioglitazone + metformin combination therapy is not defined in Korea yet.

Thus, extension of the PEAK trial for the longer treatment upto 1 year has been planned.

PEAK trial will be followed by another 28 week open-label treatment of the same drug as initial randomization (total duration of treatment as randomized 52 week), and followed by 2 year of observation.

During observation period, any antidiabetic medication can be added/changed when HbA1c of the subject is off target 7% with clinician's clinical decision.

After 3 years of initial randomization, durability of glucose control will be assessed between 3 treatment group.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: February 28, 2019
• Est. primary completion date: December 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• Completed "ALO-IIT-012(PEAK study)", without major protocol deviations.

• Male, or female, 19 years to 75 years.

• Female with childbearing potential who has a negative urine pregnancy test result at study start and willing to continue practice appropriate birth control during the entire duration of study

• Subjects completed PEAK can be included within 30 days after End Of the Study

• Subjects completed PEAK can be included if their treatment is the same as randomized even after 30 days of End Of the Study.

Exclusion Criteria:

• eGFR(Epidermal growth factor receptor) < 50mL/min

• AST(aspartate aminotransferase)/ALT(alanine aminotransaminase) >2.5 upper limit of normal

• Pregnant or lactating women

• Subject who the investigator deems inappropriate to participate in this study

• Patients with a history of bladder cancer or patients with active bladder cancer

• Patients with uninvestigated macroscopic hematuria

• Patients with cardiac failure or a history of cardiac failure (New York Heart Association [NYHA] Stages 3 to 4)

• Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, since this study drug contains lactose

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• alogliptin+pioglitazone
alogliptin and pioglitazone add on metformin
• alogliptin
nesina add on metformin
• pioglitazone
actos add on metformin

Locations

Country	Name	City	State
Korea, Republic of	Seoul St Mary's Hospital, The Catholic University of Korea	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Kun-Ho Yoon	Takeda

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving HbA1c <7% after 36 month treatment	The proportion of subjects achieving HbA1c on target < 7.0% after 36 month.	36 months after randomization
Secondary	Proportion of subjects achieving HbA1c <6.5% after 36 month treatment	The proportion of subjects achieving HbA1c on target < 6.5% after 36 month.	36 Months after randomization
Secondary	Proportion of subjects achieving HbA1c <7% after 12 month treatment	The proportion of subjects achieving HbA1c on target < 7.0% after 12 month.	12 Months after randomization
Secondary	Change in glycated hemoglobin(HbA1c) from baseline to 12 month	Change from baseline in HbA1c after 6 month of double blinded treatment followed by 6 month open treatment	baseline, 12 months
Secondary	Change in HOMA-IR(homeostasis model assessment of insulin resistance) from baseline to 36 month	Change from baseline in HOMA-IR(homeostasis model assessment of insulin resistance) after 12 month of randomized treatment followed by 24 month observation.	baseline, 36 months
Secondary	change of HOMA-beta(homeostasis model assessment of beta cell) from baseline to 36 month	Change from baseline in HOMA-beta(homeostasis model assessment of beta cell) after 12 month of randomized treatment followed by 24 month observation.	baseline, 36 months