Efficacy and Safety of Lobeglitazone Versus Sitagliptin

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02480465
• Other study ID #: 39DM14010
• Status: Recruiting
• Phase: Phase 4
• First received: June 22, 2015
• Last updated: July 6, 2015
• Start date: January 2015
• Est. completion date: March 2017

Study information

• Verified date: May 2015
• Source: Chong Kun Dang Pharmaceutical
• Contact: Hyun-Kyung Oh
• Phone: 82-2-2194-0469
• Email: hkoh[@]ckdpharm.com
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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) ? Drug Naïve ? Taking Metformin < 1000mg monotherapy and/or Taking Metformin < 12 weeks prior to this study ? 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean percent change of HbA1c		from baseline at 24 weeks	No
Secondary	The rate of Metabolic Syndrome		from baseline at 24 weeks	No
Secondary	The mean percent change of Metabolic Syndrome Components(HDL-C, TG, BP, waist line)		from baseline at 24 weeks	No
Secondary	The mean percent change of Glycemic parameters(FPG, HOMA-IR, HOMA- ß, QUICKI)		from baseline at 24 weeks	No
Secondary	The mean percent change of Lipid parameters(Total Cholesterol, LDL-C, HDL-C, Small Dense LDL-C, FFA, Apo-B)		from baseline at 24 weeks	No
Secondary	The achivement rate of HbA1c(HbA1c < 6.5%, HbA1c < 7%)		from baseline at 24 weeks	No
Secondary	The mean percent change of Adiponectin		from baseline at 24 weeks	No
Secondary	The mean percent change of hs-CRP		from baseline at 24 weeks	No
Secondary	Safety evaluation - physical examination, vital sign, laboratory, adverse event		from baseline at 24 weeks	Yes