NCT05915949

Brief Summary

Diabetes is the most frequently occurring chronic disease along with obesity, hypertension, and hyperlipidemia. The number of patients with diabetes is increasing worldwide. Despite rapid progress in management of diabetes, the problem is that glycemic target goal is still low showing 30-40%. Thus, diabetes has become a serious social, economic, and public health problem beyond individual health problems due to its increasing prevalence.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

June 14, 2023

Last Update Submit

August 10, 2023

Conditions

Diabetes Type 2

Keywords

diabetes type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Glycemic control

    6 months

Secondary Outcomes (12)

  • Fasting plasma glucose

    6 months

  • Postprandial glucose

    6 months

  • Whole body muscle

    6 months

  • Whole body fat

    6 months

  • Abdominal subcutaneous fat

    6 months

  • +7 more secondary outcomes

Other Outcomes (1)

  • Adverse events

    6 months

Study Arms (3)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10 mg once daily will be given to participants.

Drug: Dapagliflozin 10mg Tab

Lobeglitazone

ACTIVE COMPARATOR

Lobeglitazone 0.5 mg once daily will be given to participants.

Drug: Lobeglitazone 0.5 mg

Dapagliflozin and Lobeglitazone combined

ACTIVE COMPARATOR

Dapagliflozin 10 mg and lobeglitazone 0.5 mg once daily together will be given to participants.

Drug: Dapagliflozin + Lobeglitazone

Interventions

Dapagliflozin 10mg TabDRUG

Forxiga 10mg Tab once daily will be given to participants for 24 weeks.

Also known as: Forxiga 10mg
Dapagliflozin
Lobeglitazone 0.5 mgDRUG

Duvie 0.5mg Tab once daily will be given to participants for 24 weeks.

Also known as: Duvie 0.5 mg
Lobeglitazone
Dapagliflozin + LobeglitazoneDRUG

Duvie 0.5mg Tab once daily will be given to participants for 24 weeks.

Also known as: Forxiga 10mg + Duvie 0.5mg
Dapagliflozin and Lobeglitazone combined

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetic patients between the ages of 20 and 80 who are taking oral diabetes medications (metformin and/or DPP-4 inhibitors) for more than 8 weeks without dose adjustment
  • body mass index (BMI) ≥ 20 kg/m2
  • eGFR ≥ 50 mL/min/1.73 m2
  • HbA1c: 7-10%.

You may not qualify if:

  • patients with type 1 diabetes; HbA1c \<7% or HbA1c \>10%
  • fasting blood glucose (FPG) \>15 mmol/L (270 mg/dL) at the first visit (screening) and pre-randomization screening
  • women of childbearing potential (if not using proper contraception)
  • history of gastric surgery (including gastric banding within 3 years)
  • history of diabetic ketoacidosis or non-ketogenic hyperosmotic coma
  • average of 3 blood pressure measurements is systolic blood pressure (SBP) \>180 mmHg or diastolic blood pressure (DBP) \>100 mmHg
  • heart failure NYHA class III or IV
  • AST or ALT greater than 3 times the upper limit of normal
  • systemic corticosteroids have been used for 10 consecutive days within 90 days (topical, eye drop, topical or inhalation agents)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozinlobeglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Minji Sohn, PhD

CONTACT

82-031-787-704165423@snuhb.org

Study Design

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

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 23, 2023

Study Start

January 1, 2022

Primary Completion

October 30, 2023

Study Completion

December 31, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

KR(1)