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

NCT ID: NCT03770052

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-24
• Study Completion Date: 2021-09-13

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.

Conditions

Type 2 Diabetes Mellitus; Inadequate Glucose Control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

duvie

Intervention Type: DRUG

take the intervention drug once daily according to the randomized groups

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

Group Type: ACTIVE_COMPARATOR

duvie

Intervention Type: DRUG

take the intervention drug once daily according to the randomized groups

Interventions

duvie

take the intervention drug once daily according to the randomized groups

Intervention Type: DRUG

Eligibility 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 (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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical Corp.

INDUSTRY

Sponsor Role: collaborator

Pusan National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

In Ju Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pusan National University Hospital

Busan, , South Korea

Countries

South Korea

Other Identifiers

Duvie2.5

Identifier Type: -

Identifier Source: org_study_id