NCT02315287

Brief Summary

Triple combination of metformin, DPP4 inhibitor and Thiazolidinedione would be a good option in the treatment of drug-naïve Korean type 2 diabetic patients. Newly developed thiazolidinedione, Lobeglitazone would be not inferior to Pioglitazone.

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
190

participants targeted

Target at P75+ for phase_4 type-2-diabetes

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_4 type-2-diabetes

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

September 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

7.3 years

First QC Date

September 11, 2014

Last Update Submit

March 29, 2021

Conditions

Type 2 Diabetes

Keywords

Triple combinationMetforminSitagliptinPioglitazoneLobeglitazone

Outcome Measures

Primary Outcomes (1)

  • Change of HbA1c

    Comparison of therapeutic efficacy of two thiazolidinediones (Piogitazone vs. Lobeglitazone) in drug-naïve Korean type 2 diabetic patients

    5 and 12 months

Secondary Outcomes (6)

  • Beta-cell function

    12 months

  • Insulin resistance

    12 months

  • HbA1c < 7.0%

    5 and 12 months

  • HbA1c =< 6.5%

    5 and 12 months

  • FBS and PP2

    5 and 12 months

  • +1 more secondary outcomes

Other Outcomes (2)

  • Hypoglycemia

    12 months

  • Body weight

    12 months

Study Arms (2)

Metformin, Sitagliptin, Pioglitazone

ACTIVE COMPARATOR

Thiazolidinedione

Drug: Pioglitazone

Metformin, Sitagliptin, Lobeglitazone

ACTIVE COMPARATOR

Thiazolidinedione

Drug: Lobeglitazone

Interventions

PioglitazoneDRUG

Comparison of two different thiazolidinediones

Also known as: Actos
Metformin, Sitagliptin, Pioglitazone
LobeglitazoneDRUG

Comparison of two different thiazolidinediones

Also known as: Duvie
Metformin, Sitagliptin, Lobeglitazone

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HbA1c \> 13.0 %
  • No treatment with insulin or oral agents for 6 months
  • ≤ Age \< 80 years

You may not qualify if:

  • Contraindication to sitagliptin or metformin or thiazolidinedione
  • Pregnant or breast feeding women
  • Type 1 diabetes, gestational diabetes, or secondary forms of diabetes
  • Not appropriate for oral antidiabetic agent
  • Medication which affect glycemic control
  • Disease which affect efficacy and safety of drugs
  • Any major illness (Liver disease, Renal failure, Heart disease, Cancer, etc)

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

Pioglitazonelobeglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Soo Lim, MD, PhD

    SNUBH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo Lim, MD, PHD

CONTACT

82-31-787-7035limsoo@snu.ac.kr

Eu Jeong Ku, MD

CONTACT

82-31-787-6232eujeong.ku@gmail.com

Study Design

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

Study Record Dates

First Submitted

September 11, 2014

First Posted

December 11, 2014

Study Start

September 1, 2014

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 30, 2021

Record last verified: 2021-03

Locations

KR(1)