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Trial record 2 of 7 for:    examine alogliptin

An Extension Study of PEAK Trial (PEAK-E)

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ClinicalTrials.gov Identifier: NCT02763007
Recruitment Status : Recruiting
First Posted : May 5, 2016
Last Update Posted : July 14, 2017
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Kun-Ho Yoon, The Catholic University of Korea

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: alogliptin+pioglitazone Drug: alogliptin Drug: pioglitazone Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Study of Protocol ALO-IIT(PEAK Study) to Examine the Long-term Efficacy and Safety of Metformin + Alogliptin + Pioglitazone Triple Combination Therapy in the Korean Type 2 Diabetes Patients
Actual Study Start Date : May 18, 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: alogliptin+pioglitazone
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
Drug: alogliptin+pioglitazone
alogliptin and pioglitazone add on metformin
Other Name: nesina, actos

Active Comparator: alogliptin
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
Drug: alogliptin
nesina add on metformin
Other Name: nesina

Active Comparator: pioglitazone
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
Drug: pioglitazone
actos add on metformin
Other Name: actos




Primary Outcome Measures :
  1. Proportion of subjects achieving HbA1c <7% [ Time Frame: 36 months after randomization ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving HbA1c <6.5% [ Time Frame: 36 Months after randomization ]
  2. Proportion of subjects achieving HbA1c <7% [ Time Frame: 12 Months after randomization ]
  3. Comparing change of HbA1c on each group from the baseline. [ Time Frame: baseline, 12 months ]
  4. Comparing change of HOMA-IR(homeostasis model assessment of insulin resistance) on each group from the baseline. [ Time Frame: baseline, 36 months ]
  5. Comparing change of HOMA-beta on each group from the baseline. [ Time Frame: baseline, 36 months ]


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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763007


Contacts
Contact: YOON-HEE CHOI, MD,PhD 82-2-2258-8288 choiyh@catholic.ac.kr
Contact: Kun-Ho Yoon, MD, PhD 82-2-2258-2704 yoonk@catholic.ac.kr

Locations
Korea, Republic of
Seoul St Mary's Hospital, The Catholic University of Korea Recruiting
Seoul, Korea, Republic of, 137-701
Contact: YOON HEE CHOI, MD         
Principal Investigator: Kun-Ho Yoon, MD, PhD         
Sub-Investigator: Yoon-Hee Choi, MD, PhD         
Sub-Investigator: Eun-Young Lee, MD, PhD         
Sponsors and Collaborators
Kun-Ho Yoon
Takeda
Investigators
Principal Investigator: Kun-Ho Yoon, MD, PhD Seoul St Mary's Hospital, The Catholic University of Korea

Responsible Party: Kun-Ho Yoon, professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02763007     History of Changes
Other Study ID Numbers: PEAK-E
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Alogliptin
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action