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NCT Number: NCT01601990

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

LG Life Sciences

Seoul, 110-062, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with type 1 diabetes mellitus, gestational diabetes, or secondary diabetes
  • Patients who were taking or needed to take any drugs which may affect the control of blood glucose significantly (ex. glucocorticoids)
  • 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
  • Patients with NYHA class II-IV congestive heart failure
  • Patients with history of hepatic cirrhosis
  • Patients with renal failure or whose creatinine clearance was less than 60mL/min
  • Patients with dysfunctional thyroid gland (with abnormal level of TSH)
  • Patients with ALT, AST or CPK exceeding 2.5 times of the upper limit of the normal range
  • Patients with BMI below 20 kg/m2 or exceeding 40 kg/m2
  • Patients with history of asthma or major skin allergy
  • Patients taking thyroid hormone, warfarin, dicoumarin or digoxin.
  • Patients with history of hypersensitivity to metformin or biguanides.
  • Patients who took sodium channel blockers in the last 6 weeks prior to Visit 1.
  • 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.
  • Patients with other reasons who the investigator decided not to be eligible for the study

Treatment and study plan

Placebo group(once daily)

Drug

eligible patients were randomized to LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks.

LC15-0444 50mg qd

Drug

eligible patients were randomized to LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks

Primary outcomes

  1. Change of HbAlc

    Time frame: from baseline to Week 24

Secondary outcomes

  1. HbA1c Responder Rate

    Time frame: at Week 24

    HbA1c Responder Rate at Week 24: HbA1c <7 %, <6.5 %

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 18, 2012
Registry last updated
May 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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