NCT02338921

Brief Summary

To assess the efficacy of treatment with sitagliptin or dapagliflozin or lobeglitazone in type 2 diabetes mellitus patients, who had inadequate glycemic control even though use of two drug combination therapy with glimepiride and metformin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

6.9 years

First QC Date

January 11, 2015

Last Update Submit

January 2, 2022

Conditions

Type 2 Diabetes

Keywords

triple combination therapysitagliptindapagliflozinlobeglitazone

Outcome Measures

Primary Outcomes (1)

  • Glycemic target goal achievement rate

    HbA1c\< 7.0% without hypoglycemia

    24 months

Secondary Outcomes (8)

  • Beta-cell function

    6 and 24 months

  • insulin resistance

    6 and 24 months

  • Fasting blood sugar (FBS) and Post Prandial 2 hour blood glucose (PP2)

    3,6,9,12,16,20 and 24months

  • Lipid profile

    3,6,9,12,16,20 and 24months

  • Body fat

    6,12 and 24 months

  • +3 more secondary outcomes

Other Outcomes (2)

  • hypoglycemia

    3,6,9,12,16,20 and 24months

  • body weight change

    6 and 24 months

Study Arms (3)

Glimepirde, Metformin, Sitagliptin

ACTIVE COMPARATOR

Dipeptidyl peptidase-4 (DPP4) inhibitor Sitagliptin

Drug: SitagliptinDrug: GlimepirdeDrug: Metformin

Glimepirde, Metformin, Dapagliflozin

ACTIVE COMPARATOR

Sodium-glucose cotransporter 2 (SGLT2) inhibitors Dapagliflozin

Drug: DapagliflozinDrug: GlimepirdeDrug: Metformin

Glimepirde, Metformin, Lobeglitazone

ACTIVE COMPARATOR

Peroxisome proliferator-activated receptor gamma agonist Lobeglitazone

Drug: LobeglitazoneDrug: GlimepirdeDrug: Metformin

Interventions

SitagliptinDRUG

100mg qd per oral during 24months compared with other treatment groups

Also known as: Januvia
Glimepirde, Metformin, Sitagliptin
DapagliflozinDRUG

10mg qd per oral during 24months compared with other treatment groups

Also known as: Forxiga
Glimepirde, Metformin, Dapagliflozin
LobeglitazoneDRUG

0.5mg qd per oral during 24months compared with other treatment groups

Also known as: Duvie
Glimepirde, Metformin, Lobeglitazone
GlimepirdeDRUG
Also known as: Amaryl
Glimepirde, Metformin, DapagliflozinGlimepirde, Metformin, LobeglitazoneGlimepirde, Metformin, Sitagliptin
MetforminDRUG
Glimepirde, Metformin, DapagliflozinGlimepirde, Metformin, LobeglitazoneGlimepirde, Metformin, Sitagliptin

Eligibility Criteria

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

You may qualify if:

  • ≤ Age \< 80 years
  • HbA1c ≥ 7 %
  • combination therapy with glimepiride and metformin over 2 months.
  • dosage of glimepiride : 1-8mg/day
  • dosage of metformin : 500-2550mg/day

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soo Lim

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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin PhosphatedapagliflozinlobeglitazoneglimepirideMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Soo Lim, MD, PHD

    SNUBH

    PRINCIPAL INVESTIGATOR

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

January 11, 2015

First Posted

January 14, 2015

Study Start

January 1, 2015

Primary Completion

November 30, 2021

Study Completion

December 31, 2021

Last Updated

January 4, 2022

Record last verified: 2022-01

Locations

KR(1)