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

• Sponsor: Pusan National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03770052
• Collaborator: Chong Kun Dang Pharmaceutical Corp. (Industry)
• Enrollment: 159
• Location: 1
• Arms: 2
• Actual Duration (Months): 34.7
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus; Inadequate Glucose Control	Drug: duvie	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 159 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
• Actual Study Start Date: Oct 24, 2018
• Actual Primary Completion Date: Aug 19, 2021
• Actual Study Completion Date: Sep 13, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. HbA1c at 24 week [24 week]

   changes of HbA1c between baseline and 24 week

Secondary Outcome Measures

1. HOMA-IR [24 week]

   changes of HOMA-IR between baseline and 24 week

2. lipid levels [24 week]

   changes of lipid levels between baseline and 24 week

3. hs-CRP [24 week]

   changes of hs-CRP between baseline and 24 week

4. AST [24 week]

   changes of AST between baseline and 24 week

5. adiponectin [24 week]

   changes of adiponectin between baseline and 24 week

6. adverse event (weight gain,edema) [24 week]

   changes of adverse event (weight gain,edema) between baseline and 24 week

7. ALT [24 week]

   changes of ALT between baseline and 24 week

8. ALP [24 week]

   changes of ALP between baseline and 24 week

9. total bilirubin [24 week]

   changes of total bilirubin between baseline and 24 week

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. 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.

1. Laser treatment for proliferative retinopathy within 6 months

2. history of alcohol or drug abuse in the previous 3 months

3. history of most cancers not in remission for 5 years

4. Past history of bladder cancer

5. 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

6. external injury, acute infections, a history/presence of any other severe disease, or severe trauma

7. Patients who use basins - however, they can be registered by stopping 8 weeks before the start of administration of medicines for clinical trials

8. A person who has used endemic insulin for more than 7 days in the last 8 weeks

9. A person with the drug usage in the TZD series over the last eight weeks.

10. When experiencing allergies, hypersensitivity, or side effects associated with drug use in the TZD series;

11. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University Hospital	Busan		Korea, Republic of

Sponsors and Collaborators

• Pusan National University Hospital
• Chong Kun Dang Pharmaceutical Corp.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: In Ju Kim, Professor, Pusan National University Hospital
• ClinicalTrials.gov Identifier: NCT03770052
• Other Study ID Numbers: Duvie2.5
• First Posted: Dec 10, 2018
• Last Update Posted: Jan 20, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jan 20, 2022