---
title: Efficacy and Safety of Lobeglitazone Versus Sitagliptin
nct_id: NCT02480465
overall_status: UNKNOWN
phase: PHASE4
sponsor: Chong Kun Dang Pharmaceutical
study_type: INTERVENTIONAL
primary_condition: Diabetes Mellitus, Type 2
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02480465.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02480465"
ct_last_update_post_date: 2015-07-08
last_seen_at: "2026-05-12T07:18:13.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety of Lobeglitazone Versus Sitagliptin

**Official Title:** 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

**NCT ID:** [NCT02480465](https://clinicaltrials.gov/study/NCT02480465)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 248
- **Lead Sponsor:** Chong Kun Dang Pharmaceutical
- **Conditions:** Diabetes Mellitus, Type 2
- **Start Date:** 2015-01
- **Completion Date:** 2017-03
- **CT.gov Last Update:** 2015-07-08

## Brief Summary

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

## 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.

## Eligibility

- **Minimum age:** 19 Years
- **Sex:** ALL
- **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:

* 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
```

## Arms

- **Lobelitazone 0.5mg** (EXPERIMENTAL) — Lobelitazone 0.5mg
- **Sitagliptin 100mg** (ACTIVE_COMPARATOR) — Sitagliptin 100mg

## Interventions

- **Lobelitazone 0.5mg** (DRUG) — Lobelitazone 0.5mg, placebo of Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin
- **Sitagliptin 100mg** (DRUG) — placebo of Lobelitazone 0.5mg, Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin

## Primary Outcomes

- **The mean percent change of HbA1c** _(time frame: from baseline at 24 weeks)_

## Secondary Outcomes

- **The rate of Metabolic Syndrome** _(time frame: from baseline at 24 weeks)_
- **The mean percent change of Metabolic Syndrome Components(HDL-C, TG, BP, waist line)** _(time frame: from baseline at 24 weeks)_
- **The mean percent change of Glycemic parameters(FPG, HOMA-IR, HOMA- β, QUICKI)** _(time frame: from baseline at 24 weeks)_
- **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)_
- **The achivement rate of HbA1c(HbA1c < 6.5%, HbA1c < 7%)** _(time frame: from baseline at 24 weeks)_
- **The mean percent change of Adiponectin** _(time frame: from baseline at 24 weeks)_
- **The mean percent change of hs-CRP** _(time frame: from baseline at 24 weeks)_
- **Safety evaluation - physical examination, vital sign, laboratory, adverse event** _(time frame: from baseline at 24 weeks)_

## Locations (1)

- Korea University Anam Hospital, Seoul, South Korea — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.korea university anam hospital|seoul||south korea` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02480465*  
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