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

NCT03770052 | Completed Phase 4 DMC

• 1 other identifier: Duvie2.5
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus; Inadequate Glucose Control

Outcome Measures

Primary Outcomes (1)

• HbA1c at 24 week

  changes of HbA1c between baseline and 24 week

  24 week

Secondary Outcomes (9)

• HOMA-IR

  24 week

• lipid levels

  24 week

• hs-CRP

  24 week

• AST

  24 week

• adiponectin

  24 week

Study Arms (2)

0.25mg robeglitazone add-on group

EXPERIMENTAL

0.25mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy

Drug: duvie

0.5mg robeglitazone add-on group

ACTIVE COMPARATOR

0.5mg robeglitazone once daily in patients with type 2 diabetes with inadequate control on metformin and DPP-4 inhibitor therapy

Drug: duvie

Interventions

duvie DRUG

take the intervention drug once daily according to the randomized groups

0.25mg robeglitazone add-on group; 0.5mg robeglitazone add-on group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type Ⅱ diabetes mellitus
• Between 19 years and 80 years old
• BMI between 20kg/㎡ to 45kg/㎡
• 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
• HbA1c 7.0 to 9.0
• Agreement with written informed consent

You may not qualify if:

• Historical history of severe heart failure or heart failure (NYHA Class III\&IV)
• Rapid coronary syndrome, cardiovascular interventions within 6 months
• History of cerebral vascular diseases within six months
• High blood pressure uncontrolled (\>160/100 mmHg)
• In case weight loss drug is used within 3 months
• In case of systemic corticosteroids treatment within 3 months
• If there is an allergy or overreaction to the study drug or its components
• In case of acute metabolic complications (ketonicemia or high osmotic pressure) within 6 months
• Anemia Hb \< 12g/dL(male), 10g/dL(female)
• Kidney function GFR \< 45mL/min/1.73m2 (GFR test results are calculated by the Cockcroft-Gault Calculator).
• impaired hepatic function (AST/ALT 2.5-fold the upper limit of the normal range \[ULN\])
• TG\>500 mg/dL
• LDL cholesterol \>160 mg/dL
• \- If a lipid-lowering agent is being taken, the existing dose should be taken during the study period.
• The thyroid hormone is within its normal range

Sponsors & Collaborators

• Pusan National University Hospital: lead
• Chong Kun Dang Pharmaceutical Corp.: collaborator

Study Sites (1)

Pusan National University Hospital

Busan, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 10, 2018
• Study Start: October 24, 2018
• Primary Completion: August 19, 2021
• Study Completion: September 13, 2021
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)