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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01601990
First received: May 15, 2012
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Placebo group(once daily)
Drug: LC15-0444 50mg qd
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • Change of HbAlc [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c Responder Rate [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
    HbA1c Responder Rate at Week 24: HbA1c <7 %, <6.5 %


Enrollment: 189
Study Start Date: December 2009
Study Completion Date: November 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601990

Locations
Korea, Republic of
LG Life Sciences
Seoul, Korea, Republic of, 110-062
Sponsors and Collaborators
LG Life Sciences
Investigators
Principal Investigator: Se Hyun Baek, MD, PhD Korea University Guro Hospital
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01601990     History of Changes
Other Study ID Numbers: LG-DPCL005
Study First Received: May 15, 2012
Last Updated: May 17, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 22, 2014