Clinical trial NCT02480465: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-06-24
Enrollment: 248
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: 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

Primary outcomes:
measure: The mean percent change of HbA1c
timeFrame: from baseline at 24 weeks
Secondary outcomes:
measure: The rate of Metabolic Syndrome
timeFrame: from baseline at 24 weeks
measure: The mean percent change of Metabolic Syndrome Components(HDL-C, TG, BP, waist line)
timeFrame: from baseline at 24 weeks
measure: The mean percent change of Glycemic parameters(FPG, HOMA-IR, HOMA- β, QUICKI)
timeFrame: from baseline at 24 weeks
measure: The mean percent change of Lipid parameters(Total Cholesterol, LDL-C, HDL-C, Small Dense LDL-C, FFA, Apo-B)
timeFrame: from baseline at 24 weeks
measure: The achivement rate of HbA1c(HbA1c < 6.5%, HbA1c < 7%)
timeFrame: from baseline at 24 weeks
measure: The mean percent change of Adiponectin
timeFrame: from baseline at 24 weeks
measure: The mean percent change of hs-CRP
timeFrame: from baseline at 24 weeks
measure: Safety evaluation - physical examination, vital sign, laboratory, adverse event
timeFrame: from baseline at 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Dong-Sub Choi
role: PRINCIPAL_INVESTIGATOR
References: