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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Inadequate Glucose Control
• Intervention / Treatment: Drug: duvie

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Pusan National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 (ketonicemia 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c at 24 week	changes of HbA1c between baseline and 24 week	24 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HOMA-IR	changes of HOMA-IR between baseline and 24 week	24 week
lipid levels	changes of lipid levels between baseline and 24 week	24 week
hs-CRP	changes of hs-CRP between baseline and 24 week	24 week
AST	changes of AST between baseline and 24 week	24 week
adiponectin	changes of adiponectin between baseline and 24 week	24 week
adverse event (weight gain,edema)	changes of adverse event (weight gain,edema) between baseline and 24 week	24 week
ALT	changes of ALT between baseline and 24 week	24 week
ALP	changes of ALP between baseline and 24 week	24 week
total bilirubin	changes of total bilirubin between baseline and 24 week	24 week

Collaborators and Investigators

• Sponsor: Pusan National University Hospital
• Collaborators: Chong Kun Dang Pharmaceutical Corp.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2018
• Primary Completion (Actual): August 19, 2021
• Study Completion (Actual): September 13, 2021

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Duvie2.5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No