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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

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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