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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; Inadequate Glucose Control
• Interventions: Drug: duvie

• Registration Number: NCT03770052
• Lead Sponsor: Pusan National University Hospital

Brief Summary

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

• Study Start: 2018-10-24
• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-10
• Primary Completion: 2021-08-19
• Study Completion: 2021-09-13
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.5mg robeglitazone add-on group	duvie	0.5mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy
0.25mg robeglitazone add-on group	duvie	0.25mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy

Primary Outcome Measures

Name	Time	Method
HbA1c at 24 week	24 week	changes of HbA1c between baseline and 24 week

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of