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Type 2 Diabetes MellitusPhase 4PEAKNCT02231021

The Practical Evidence of Antidiabetic Combination Therapy in Korea

A Phase 4 study testing alogliptin, Pioglitazone and alogliptin + pioglitazone in people with Type 2 Diabetes Mellitus, run by Kun-Ho Yoon at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
alogliptin, Pioglitazone and alogliptin + pioglitazone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteSouth Korea
Study dates
Sep 2014to 28 Jan 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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 locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul St Mary's Hospital, The Catholic University of Korea

    Seoul, 137-701

Other trials in South Korea

About this study

Official title: 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

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.

Read the detailed 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.

Being tested
alogliptin, Pioglitazone, alogliptin + pioglitazone
Keywords
Diabetes Mellitus, Type 2, alogliptin, pioglitazone, DPP4 inhibitor, thiazolidinedione
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alogliptinDrug

    Also called Nesina

    alogliptin 25 mg add-on background medication metformin

  • PioglitazoneDrug

    Also called actos

    pioglitazone 30 mg add-on background medication metformin

  • alogliptin + pioglitazoneDrug

    Also called Nesina, Actos

    alogliptin 25 mg and pioglitazone 30 mg add-on background medication metformin

Study groups in NCT02231021
Study groupRoleWhat they receive
alogliptin + pioglitazoneExperimentalalogliptin 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
Receives: Drug: alogliptin + pioglitazone
alogliptinActive comparatoralogliptin 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
Receives: Drug: alogliptin
PioglitazoneActive comparatoralogliptin 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
Receives: Drug: Pioglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glycohemoglobin(HbA1c) from baseline

    Measured: baseline, 24 weeks

Secondary outcomes (31)

  1. Proportion of subjects achieving HbA1c < 7.0%

    Measured: 24 week

  2. Proportion of subjects achieving HbA1c <6.5%

    Measured: 24 week

  3. Changes in glycated albumin(GA) from baseline

    Measured: baseline, 24 weeks

  4. Change in GA/HbA1c ratio from baseline

    Measured: baseline, 24 weeks

  5. Change in fasting blood sugar from baseline

    Measured: baseline, 24 weeks

  6. Incidence of hyperglycemic rescue

    at Week 12, HbA1c >9.0%

    Measured: 12 week

  7. Change in HbA1c from baseline

    Measured: 12 week

  8. Change in total cholesterol from baseline

    Measured: baseline, 24 weeks

  9. Change in triglycerides from baseline

    Measured: baseline, 24 weeks

  10. Change in LDL-cholesterol from baseline

    Measured: baseline, 24 weeks

  11. Change in HDL-cholesterol from baseline

    Measured: baseline, 24 weeks

  12. Changes in glycated albumin(GA) from baseline

    Measured: baseline, 12 weeks

  13. Change in GA/HbA1c ratio from baseline

    Measured: baseline, 12 weeks

  14. Change in fasting blood sugar from baseline

    Measured: baseline, 12 weeks

  15. Change in total cholesterol from baseline

    Measured: baseline, 12 weeks

  16. Change in triglycerides from baseline

    Measured: baseline, 12 weeks

  17. Change in LDL-cholesterol from baseline

    Measured: baseline, 12 weeks

  18. Change in HDL-cholesterol from baseline

    Measured: baseline, 12 weeks

  19. Change in Homeostasis Model Assessment-Insulin resistance(HOMA-IR) from baseline

    a marker of insulin resistance

    Measured: baseline, 24 weeks

  20. Change in Homeostasis Model Assessment - beta cell (HOMA-beta) from baseline

    a marker of beta cell function

    Measured: baseline, 24 weeks

  21. Change in highly sensitive C reactive protein(hs-CRP) from baseline

    a marker of inflammation

    Measured: baseline, 24 weeks

  22. Change in Plasmonogen activator inhibitor-1(PAI-1) from baseline

    Measured: baseline, 24 weeks

  23. Change in B-type natriuretic pepetide(BNP) from baseline

    Measured: baseline, 24 weeks

  24. event rate of hypoglycemia

    A number of total event of hypoglycemia defined as blood glucose <70mg/dL or subjective symptom of typical hypoglycemia

    Measured: upto 24 weeks

  25. No of subject with adverse event of special interest

    The event of special interest include

    • heart failure
    • cardiovascular effect other than heart failure
    • edema
    • weight gain
    • urinary bladder tumor
    • macular edema
    • fracture of bone
    • pancreatitis

    Measured: upto 24 weeks

  26. The number of serious adverse events

    Measured: upto 24 weeks

  27. The number of subject with hypersensitivity to study drugs

    Measured: upto 24 weeks

  28. The number of subject with any abnormality of laboratory evaluation

    • Complete Blood count
    • BUN, Creatinine, AST, ALT, Calcium, Phosphorous, Sodium, Potassium, Total Protein, Albumin, Total Bilirubin, Gamma-glutamyl transferase, Alkaline phosphatase, Creatinine Kinase, amylase, lipase
    • Urine analysis including microscopic examination

    Measured: 12 week

  29. The number of subject with any abnormality of laboratory evaluation

    • Complete Blood count
    • Blood urea nigrogen, Creatinine, Aspartate aminotransferase, Alanine Aminotransferase, Calcium, Phosphorous, Sodium, Potassium, Total Protein, Albumin, Total Bilirubin, Gamma-glutamyl transferase, Alkaline phosphatase, Creatinine Kinase, amylase, lipase
    • Urine analysis including microscopic examination

    Measured: 24 week

  30. The number of subject with any change of findings in Chest X-ray from baseline

    Measured: 24 week

  31. The number of subject with any change of findings in electrocardiogram from baseline

    Measured: 24 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completion22 Oct 2018
  4. Study completion28 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02231021
Sponsor's protocol ID
ALO-IIT-012
Acronym
PEAK
Status last verified
Feb 2019
First submitted
29 Aug 2014
Last updated
8 Feb 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing alogliptin, Pioglitazone and alogliptin + pioglitazone in people with Type 2 Diabetes Mellitus, run by Kun-Ho Yoon at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in glycohemoglobin(HbA1c) from baseline (time frame: baseline, 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02231021.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.

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