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

Pusan National University

Status and phase

Completed

Phase 4

Conditions

Inadequate Glucose Control

Type 2 Diabetes Mellitus

Treatments

Drug: duvie

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03770052

Duvie2.5

Details and patient eligibility

About

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

Full 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.

Enrollment

159 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
- however, thyroid hormone may be registered at the discretion of the investigator even if it is outside the normal range.
Laser treatment for proliferative retinopathy within 6 months
history of alcohol or drug abuse in the previous 3 months
history of most cancers not in remission for 5 years
Past history of bladder cancer
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
external injury, acute infections, a history/presence of any other severe disease, or severe trauma
Patients who use basins - however, they can be registered by stopping 8 weeks before the start of administration of medicines for clinical trials
A person who has used endemic insulin for more than 7 days in the last 8 weeks
A person with the drug usage in the TZD series over the last eight weeks.
When experiencing allergies, hypersensitivity, or side effects associated with drug use in the TZD series;
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.