Diabetes Mellitus, Type 2
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGalogliptin+pioglitazone
alogliptin and pioglitazone add on metformin
DRUGalogliptin
nesina add on metformin
DRUGpioglitazone
actos add on metformin
Sponsors
Takeda
Kun-Ho Yoon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving HbA1c <7% after 36 month treatment | 36 months after randomization | The proportion of subjects achieving HbA1c on target \< 7.0% after 36 month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HOMA-IR(homeostasis model assessment of insulin resistance) from baseline to 36 month | baseline, 36 months | Change from baseline in HOMA-IR(homeostasis model assessment of insulin resistance) after 12 month of randomized treatment followed by 24 month observation. |
| Proportion of subjects achieving HbA1c <6.5% after 36 month treatment | 36 Months after randomization | The proportion of subjects achieving HbA1c on target \< 6.5% after 36 month. |
| Proportion of subjects achieving HbA1c <7% after 12 month treatment | 12 Months after randomization | The proportion of subjects achieving HbA1c on target \< 7.0% after 12 month. |
| Change in glycated hemoglobin(HbA1c) from baseline to 12 month | baseline, 12 months | Change from baseline in HbA1c after 6 month of double blinded treatment followed by 6 month open treatment |
| change of HOMA-beta(homeostasis model assessment of beta cell) from baseline to 36 month | baseline, 36 months | Change from baseline in HOMA-beta(homeostasis model assessment of beta cell) after 12 month of randomized treatment followed by 24 month observation. |
Countries
South Korea
Outcome results
None listed