An Extension Study of PEAK Trial (PEAK-E)

K

Kun-Ho Yoon

Status and phase

Terminated
Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: pioglitazone
Drug: alogliptin+pioglitazone
Drug: alogliptin

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02763007
PEAK-E

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

41 participants in 3 patient groups

alogliptin+pioglitazone
Experimental group
Description:
A group who treat with alogliptin+pioglitazone: The Combination of Alogliptin 25 mg and pioglitazone 30 mg daily add on metformin for 28 week as extension and followed by 2 years of observation
Treatment:
Drug: alogliptin+pioglitazone
alogliptin
Active Comparator group
Description:
A group who treat with alogliptin: Alogliptin 25 mg daily add on metformin for for 28 week as extension and followed by 2 years of observation
Treatment:
Drug: alogliptin
pioglitazone
Active Comparator group
Description:
A group who treat with pioglitazone: Pioglitazone 30 mg daily add on metformin for for 28 week as extension and followed by 2 years of observation
Treatment:
Drug: pioglitazone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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