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The Practical Evidence of Antidiabetic Combination Therapy in Korea (PEAK)

K

Kun-Ho Yoon

Status and phase

Completed
Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: alogliptin + pioglitazone
Drug: Pioglitazone
Drug: alogliptin

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02231021
ALO-IIT-012

Details and patient eligibility

About

This study evaluate the efficacy and safety of alogliptin and pioglitazone combination therapy in comparison with either alogliptin or pioglitazone on glucose control in the metformin-treated type 2 diabetic patients in Korea.

Full description

Pathophysiology of type 2 diabetes is known as insulin resistance and progressive beta cell dysfunction.

Combination therapy with biguanides, glucagon-like peptide-1(GLP-1) agonists or dipeptidyl peptidase-4 inhibitor(DPP4I) and thiazolidinediones(TZD) seems reasonable theoretically, for their effects on different pathophysiologic defects.

Current treatment guidelines recommend a stepwise approach starting with lifestyle modification or lifestyle modification + metformin monotherapy, with recent focusing on patient individualization.

In Korea, Korean Diabetes Association also recommends stepwise approach and at the same time, emphasizes on the initial aggressive treatment including oral combination or insulin therapy according to HbA1c level to achieve target goal <6.5%.

Guide to the efficacy, timing, options of combination therapy is not clearly defined due to lack of sufficient evidences yet.

There is no clear report to demonstrate the clinical benefit of initial TZD and DPP4I combination therapy in the Korean.

Thus it is reasonable to study the effect of combination therapy in the patients with sub-optimal glucose control with metformin therapy only, comparing various combination options metformin with DPP4I only, TZD only, or both.

The hypothesis of this study is that combination therapy of alogliptin and pioglitazone added on the metformin has superior effect on HbA1c reduction than metformin and either alogliptin or pioglitazone in 6 month treatment.

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Enrollment

216 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements
  • The subject or, when applicable, the subject's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures
  • The subjects diagnosed type 2 diabetes mellitus at least 6 months
  • Male and female and 19 to 75 years, inclusive
  • 7.0% =<HbA1c =<10.0%
  • 18.5 Kg/m2 =<Body Mass Index(BMI) =<45 kg/m2
  • systolic/diastolic blood pressure =<160/100 at baseline
  • hemoglobin of at least 12 g/dL for men and at least 10 g/dL for women
  • A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from singing of informed consent throughout the duration of the study
  • Patient who receiving maximal tolerated dose of metformin at least 12 weeks without dose change (for metformin, >= 1,000 mg/day
  • fasting c-peptide greater than 0.78 ng/mL(0.26 nmol/L) at baseline

Exclusion criteria

  • The patient has received investigational compound(alogliptin or pioglitazone) within 180 days prior to baseline
  • Patient who currently taking or need to take andy medicine which may exert a significant influence on blood glucose control except metformin.
  • Severe renal disease : estimated glomerular filtration rate <50 mL/min
  • Severe liver disease or AST, ALT >= 2.5 upper limit of normal
  • Cardiac status : New York Heart Association III ~ IV
  • Hypopituitarism or adrenal insufficiency
  • Patient who has a history of major surgery, Severe infections, Severe traumas within 6 months
  • Patients who has diagnosed malignancy within 5yrs ,
  • Patients with active bladder cancer
  • Patient with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
  • Patient who has a history of hypersensitivity to Alogliptin, Pioglitazone or their ingredients
  • Pregnant or lactating woman
  • Patient who has history of excessive alcohol abuse
  • Subject who is involved in other clinical trial within 90 days prior to initiation of this study.
  • Subject who the investigator deems inappropriate to participate in this study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

216 participants in 3 patient groups

alogliptin + pioglitazone
Experimental group
Description:
alogliptin 25 mg 1 tablet daily for 24 weeks pioglitazone 30 mg 1 tablet daily for 24 weeks metformin for 24 weeks as the same dose and frequency as before enroll
Treatment:
Drug: alogliptin + pioglitazone
alogliptin
Active Comparator group
Description:
alogliptin 25 mg 1 tablet daily for 24 weeks pioglitazone matching placebo 1 tablet daily for 24 weeks metformin for 24 weeks as the same dose and frequency as before enroll
Treatment:
Drug: alogliptin
Pioglitazone
Active Comparator group
Description:
alogliptin matching placebo 1 tablet daily for 24 weeks pioglitazone 30 mg 1 tablet daily for 24 weeks metformin for 24 weeks as the same dose and frequency as before enroll
Treatment:
Drug: Pioglitazone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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