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Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie

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ClinicalTrials.gov Identifier: NCT03770052
Recruitment Status : Not yet recruiting
First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Collaborator:
Chong Kun Dang Pharmaceutical Corp.
Information provided by (Responsible Party):
In Ju Kim, Pusan National University Hospital

Brief Summary:
This study is a double blind, randomized, investigator initiated study on glucose-lowering effects and Safety of Adding 0.25 or 0.5 mg Duvie (Lobeglitazone) in Patients With Type 2 Diabetes With Inadequate Control on Metformin and DPP-4 Inhibitor Therapy. The primary aim of the study is to compared changes of HbA1c between 0.25mg robeblitazone add-on group and 0.5mg robeglitazone add-on group.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Inadequate Glucose Control Drug: duvie Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Investigator Initiated Study on Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie (Lobeglitazone) in Patients With Type 2 Diabetes With Inadequate Control on Metformin and DPP-4 Inhibitor Therapy
Estimated Study Start Date : December 20, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 0.25mg robeglitazone add-on group
0.25mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy
Drug: duvie
take the intervention drug once daily according to the randomized groups

Active Comparator: 0.5mg robeglitazone add-on group
0.5mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy
Drug: duvie
take the intervention drug once daily according to the randomized groups




Primary Outcome Measures :
  1. HbA1c at 24 week [ Time Frame: 24 week ]
    changes of HbA1c between baseline and 24 week


Secondary Outcome Measures :
  1. HOMA-IR [ Time Frame: 24 week ]
    changes of HOMA-IR between baseline and 24 week

  2. lipid levels [ Time Frame: 24 week ]
    changes of lipid levels between baseline and 24 week

  3. hs-CRP [ Time Frame: 24 week ]
    changes of hs-CRP between baseline and 24 week

  4. AST [ Time Frame: 24 week ]
    changes of AST between baseline and 24 week

  5. adiponectin [ Time Frame: 24 week ]
    changes of adiponectin between baseline and 24 week

  6. adverse event (weight gain,edema) [ Time Frame: 24 week ]
    changes of adverse event (weight gain,edema) between baseline and 24 week

  7. ALT [ Time Frame: 24 week ]
    changes of ALT between baseline and 24 week

  8. ALP [ Time Frame: 24 week ]
    changes of ALP between baseline and 24 week

  9. total bilirubin [ Time Frame: 24 week ]
    changes of total bilirubin between baseline and 24 week



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type Ⅱ diabetes mellitus
  2. Between 19 years and 80 years old
  3. BMI between 20kg/㎡ to 45kg/㎡
  4. Among those using Metformin and DPP-4 inhibitor merging therapy for more than 3 months, A person who has not changed the dosage of Metformin 500 mg and DPP-4 inhibitor for more than 8 weeks at the time of screening
  5. HbA1c 7.0 to 9.0
  6. Agreement with written informed consent

Exclusion Criteria:

  1. Historical history of severe heart failure or heart failure (NYHA Class III&IV)
  2. Rapid coronary syndrome, cardiovascular interventions within 6 months
  3. History of cerebral vascular diseases within six months
  4. High blood pressure uncontrolled (>160/100 mmHg)
  5. In case weight loss drug is used within 3 months
  6. In case of systemic corticosteroids treatment within 3 months
  7. If there is an allergy or overreaction to the study drug or its components
  8. In case of acute metabolic complications (cetonicemia or high osmotic pressure) within 6 months
  9. Anemia Hb < 12g/dL(male), 10g/dL(female)
  10. Kidney function GFR < 45mL/min/1.73m2 (GFR test results are calculated by the Cockcroft-Gault Calculator).
  11. impaired hepatic function (AST/ALT 2.5-fold the upper limit of the normal range [ULN])
  12. TG>500 mg/dL
  13. LDL cholesterol >160 mg/dL

    - If a lipid-lowering agent is being taken, the existing dose should be taken during the study period.

  14. The thyroid hormone is within its normal range

    - however, thyroid hormone may be registered at the discretion of the investigator even if it is outside the normal range.

  15. Laser treatment for proliferative retinopathy within 6 months
  16. history of alcohol or drug abuse in the previous 3 months
  17. history of most cancers not in remission for 5 years
  18. Past history of bladder cancer
  19. Women nursing or pregnant Persons who are not using effective contraceptive methods, or who refuse to use contraceptives as specified below (permitted contraceptives: condoms, castings, or implantation contraceptives, etc.) are installed with contraceptives in the uterus
  20. external injury, acute infections, a history/presence of any other severe disease, or severe trauma
  21. Patients who use basins - however, they can be registered by stopping 8 weeks before the start of administration of medicines for clinical trials
  22. A person who has used endemic insulin for more than 7 days in the last 8 weeks
  23. A person with the drug usage in the TZD series over the last eight weeks.
  24. When experiencing allergies, hypersensitivity, or side effects associated with drug use in the TZD series;
  25. The researcher determines that other participants may experience difficulties in participating in the test through to the end, or that participation in the test may result in additional risks or confusion in the test results.

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): NCT03770052


Contacts
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Contact: In Joo Kim +82-51-240-7228 mskim@pnuh.co.kr
Contact: Sang Soo Kim +82-51-240-7228 drsskim7@gmail.com

Locations
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Korea, Republic of
Pusan National University Hospital
Busan, Korea, Republic of
Sponsors and Collaborators
Pusan National University Hospital
Chong Kun Dang Pharmaceutical Corp.

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Responsible Party: In Ju Kim, Professor, Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT03770052     History of Changes
Other Study ID Numbers: Duvie2.5
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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