NCT02188186

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4 type-2-diabetes

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

4.2 years

First QC Date

July 7, 2014

Last Update Submit

March 14, 2019

Conditions

Type 2 Diabetes

Keywords

triple combinationmetforminsitagliptinthiazolidinedione

Outcome Measures

Primary Outcomes (1)

  • Change of HbA1c

    Therapeutic efficacy of triple combination of metform, sitagliptin, and lobeglitazone compared with sulfonylurea and metformin in drug-naïve Korean type 2 diabetic patients

    12 months

Secondary Outcomes (7)

  • beta-cell function

    12 months

  • Insulin resistance

    12 months

  • Glucose homeostasis

    12 months

  • Glucose metabolism

    12 months

  • Glucose metabolism

    12 months

  • +2 more secondary outcomes

Other Outcomes (3)

  • Hypoglycemia

    12 months

  • Body weight

    12 months

  • Body composition

    12 months

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR

Initial dual combination therapy with sulfonylurea and metfomin. Dose of sulfonylurea (glimepride 2-8 mg) and metfomin (500-2550 mg) can be ecalated at investigator's discreition at every visit. Insulin therpy can be added as a rescue therapy at investigator's discreition.

Drug: Conventional treatment

Initial triple combination treatment

EXPERIMENTAL

Initial dual combination therapy with metformin, sitagliptin (Januvia 100 mg), and lobeglitazone (Duvie 0.5 mg). Insulin therpy can be added as a rescue therapy at investigator's discreition.

Drug: Initial triple combination

Interventions

Initial triple combinationDRUG

Initial triple combination arm

Also known as: metformin+sitagliptin (Januvia)+lobeglitazone (Duvie)
Initial triple combination treatment
Conventional treatmentDRUG

Conventioanl treament with dose escalation

Also known as: metformin+sulfonylurea with dose escalation
Conventional treatment

Eligibility Criteria

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

You may qualify if:

  • HbA1c 9-12%
  • No treatment with insulin or oral agents for recent 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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MetforminBiguanidesGuanidinesAmidinesOrganic ChemicalsSitagliptin PhosphateTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesDrug CombinationsPharmaceutical Preparations

Study Design

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

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 11, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

March 18, 2019

Record last verified: 2019-03

Locations

KR(1)