Phase 3 Trial to Evaluate the Efficacy and Safety of LC15-0444 in Patients With Type 2 Diabetes

A Multicenter, Multinational, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase 3 Trial to Evaluate the Efficacy and Safety of LC15-0444 in Patients With Type 2 Diabetes

Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group study The study was divided into three parts: part 1 was started with an initial 2 weeks of exercise/diet program followed by another 2 weeks of single-blind placebo run-in period; part 2 was a double-blind treatment period during which eligible patients were randomized to LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks; part 3 was for those patients who completed part 1 & 2 and consented to receive another 28 weeks of treatment with LC15-0444 50mg. Screening tests were performed on the patients who had given the written informed consent. After 2-week exercise/diet program according to the generally recognized guideline, patients took placebo for another 2 weeks while continuing exercise/diet program. When the 2-week placebo run-in period was completed, eligible patients were assigned either to placebo or 50 mg of LC15-0444 with 1:1 ratio. During the total of 24- week treatment period of part 2 after randomization, each patient visited the investigational site at Week 6, 12, 18, and 24. Completing treatment with placebo or LC15-0444 50mg for 24 weeks after randomization, each patient was asked to provide consent to participate in the part 3 of the study where all the patients were to receive LC15-0444 50mg regardless of the treatment received during the part 2 of the study. During 28-week treatment period of the part 3, each patient visited the investigational site at Week 30, 38, 46, and 52. Total study period from screening was 56 weeks per each patient.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo group(once daily); Drug: LC15-0444 50mg qd

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-062
    • LG Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with Type 2 Diabetes Mellitus
2. Adults between 18 and 75 of age
3. Patients with HbA1c between 7 % and 11 %
4. Patient who had not received any diabetic medications within 6 weeks from screening
5. Patients who signed on the consent form after informed on the object, method, and risks of the clinical study

Exclusion Criteria:

1. Patients with type 1 diabetes mellitus, gestational diabetes, or secondary diabetes
2. Patients who were taking or needed to take any drugs which may affect the control of blood glucose significantly (ex. glucocorticoids)
3. Patients who had experienced myocardial infarction, unstable angina or prior history of coronary artery bypass surgery within 6 months prior to screening, or patients with arrhythmia requiring treatment
4. Patients with NYHA class II-IV congestive heart failure
5. Patients with history of hepatic cirrhosis
6. Patients with renal failure or whose creatinine clearance was less than 60mL/min
7. Patients with dysfunctional thyroid gland (with abnormal level of TSH)
8. Patients with ALT, AST or CPK exceeding 2.5 times of the upper limit of the normal range
9. Patients with BMI below 20 kg/m2 or exceeding 40 kg/m2
10. Patients with history of asthma or major skin allergy
11. Patients taking thyroid hormone, warfarin, dicoumarin or digoxin.
12. Patients with history of hypersensitivity to metformin or biguanides.
13. Patients who took sodium channel blockers in the last 6 weeks prior to Visit 1.
14. Patients who were treated with insulin or glucagon-like peptide-1 (GLP-1) analogue or who took thiazolidinediones (Glitazone) in the last 6 months prior to Visit 1.
15. Patients with other reasons who the investigator decided not to be eligible for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo group(once daily); eligible patients were randomized to LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks.
Experimental: LC15-0444	Drug: LC15-0444 50mg qd; eligible patients were randomized to LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of HbAlc	from baseline to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c Responder Rate	HbA1c Responder Rate at Week 24: HbA1c <7 %, <6.5 %	at Week 24

Collaborators and Investigators

• Sponsor: LG Life Sciences
• Investigators: Principal Investigator: Se Hyun Baek, MD, PhD, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: May 15, 2012
• First Submitted That Met QC Criteria: May 17, 2012
• First Posted (Estimate): May 18, 2012

Study Record Updates

• Last Update Posted (Estimate): May 18, 2012
• Last Update Submitted That Met QC Criteria: May 17, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: LG-DPCL005