CClinicalTrials.gg
Status unknownNCT02480465Updated Jul 8, 2015

Efficacy and Safety of Lobeglitazone Versus Sitagliptin

A Phase 4 interventional study of Lobelitazone 0.5mg and Sitagliptin 100mg in Diabetes Mellitus, Type 2, sponsored by Chong Kun Dang Pharmaceutical. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2015-07-08.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
248
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome.

Read the detailed description

Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome: 24-week, Multi-center, Randomized, Double-blind, Phase 4 Study.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 248 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ≥19 years old
  • Waist line: male ≥ 90cm, female ≥ 85cm
  • Applied to 1 or more categories listed below (NCEP-ATP III)

    1. SBP ≥ 130mmHg and/or DBP ≥ 85mmHg and/or taking drug for BP control
    2. HDL-C: male \< 40mg/dl, female \< 50mg/dl and/or taking drug for HDL-C increase
    3. TG ≥ 150mg/dl and/or taking drug for TG control
  • At visit 1: Applied to 1 or more categories listed below

    1. Type 2 DM Patients who does not need stabilization period : 7% ≤ HbA1c ≤ 10%, if treated with Metformin ≥ 1000mg monotherapy at least 12 weeks prior to this study → Visit 3(Randomization)
    2. Type 2 DM Patients who need stabilization period : 7% ≤ HbA1c ≤ 10%, if not treated with Metformin ≥ 1000mg monotherapy at least 12 weeks prior to this study (Applied to 1 or more categories listed below) ① Drug Naïve ② Taking Metformin \< 1000mg monotherapy and/or Taking Metformin \< 12 weeks prior to this study ③ Taking OHA
  • At visit 2(After 12 weeks of stabilization period): 7% ≤ HbA1c ≤ 10%
  • Patients who signed informed consent form

Exclusion criteria

Exclusion Criteria:

  • Type 1 DM Patients or secondary DM
  • Patients with ketoacidosis
  • Patients with taking insulin > 7 days within 12 weeks
  • Hypersensitive to biguanide and/or glitazone and/or DPP4-inhibitor
  • Patients with taking corticosteroid > 7 days within 4 weeks
  • Patients with lactic acidosis
  • Patients with galactose intolerance and/or Lapp lactase deficiency and/or glucose-galactose malabsorption
  • Patients with innutrition and/or starvation and/or weakness and/or pituitary insufficiency and/or addisons disease
  • History of malignant tumor within 5 years
  • History of drug or alcohol abuse within 12 weeks
  • Patients with congestive heart failure(NYHA class III\~IV) or uncontrolled arrythmia within 6 months
  • Patients with acute cardiovasvular disaese with 12 weeks
  • Applied to 1 or more categories listed below

    1. AST and/or ALT ≥ 3*ULN
    2. Serum creatinine: male ≥ 1.5mg/dl, female ≥ 1.4mg/dl
    3. Hb \< 10.5g/dl
  • Women with pregnant, breast-feeding
  • Childbearing age who don't use adequate contraception
  • Patients who have participated in other clinical trials
  • Not eligible to participate for the study at the discretion of investigator
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
248 participants (estimated)

Study arms

  • Experimental
    Lobelitazone 0.5mg

    Lobelitazone 0.5mg

    Drug: Lobelitazone 0.5mg

  • Active comparator
    Sitagliptin 100mg

    Sitagliptin 100mg

    Drug: Sitagliptin 100mg

Interventions

  • DrugLobelitazone 0.5mg

    Lobelitazone 0.5mg, placebo of Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin

  • DrugSitagliptin 100mg

    placebo of Lobelitazone 0.5mg, Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin

06

What researchers measure

Primary outcomes

  1. The mean percent change of HbA1c

    Time frame: from baseline at 24 weeks

Secondary outcomes

  1. The rate of Metabolic Syndrome

    Time frame: from baseline at 24 weeks

  2. The mean percent change of Metabolic Syndrome Components(HDL-C, TG, BP, waist line)

    Time frame: from baseline at 24 weeks

  3. The mean percent change of Glycemic parameters(FPG, HOMA-IR, HOMA- β, QUICKI)

    Time frame: from baseline at 24 weeks

  4. The mean percent change of Lipid parameters(Total Cholesterol, LDL-C, HDL-C, Small Dense LDL-C, FFA, Apo-B)

    Time frame: from baseline at 24 weeks

  5. The achivement rate of HbA1c(HbA1c < 6.5%, HbA1c < 7%)

    Time frame: from baseline at 24 weeks

  6. The mean percent change of Adiponectin

    Time frame: from baseline at 24 weeks

  7. The mean percent change of hs-CRP

    Time frame: from baseline at 24 weeks

  8. Safety evaluation - physical examination, vital sign, laboratory, adverse event

    Time frame: from baseline at 24 weeks

07

Study locations

1 of 1 sites recruiting
  • Korea University Anam Hospital
    Seoul, Korea, Republic of
    • Dong-sub Choi · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02480465
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Jun 24, 2015
Start date
Jan 2015
Primary completion
Dec 2016 (estimated)
Completion
Mar 2017 (estimated)
Last update
Jul 8, 2015

Study contacts

Hyun-Kyung Oh
Contact
hkoh@ckdpharm.com
82-2-2194-0469
Dong-Sub Choi
principal investigator · Korea University Anam Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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