Back to resultsPhase III Trial to Evaluate the Efficacy and Safety of LC15-0444 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LC15-0444 25mg bid
LC15-0444 50mg qd
Sitagliptin 100mg qd
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Patients with Type 2 Diabetes Mellitus
- Adults between 18 and 75 years of age
- Patients with HbA1c between 7% and 11%
- Patients treated with metformin monotherapy for at least 12 weeks and treated with 1000 mg/day or higher dose of metformin for at least 4 weeks right before 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 60 ml/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 with history of hypersensitivity to thiazolidinediones
- 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
Sites / Locations
- LG Life Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
LC15-0444 25 mg bid
LC15-0444 50 mg qd
Sitagliptin 100mg qd
Arm Description
LC15-0444 25 mg bid(twice daily)added on Metformin therapy
LC15-0444 50 mg qd(once daily) added on Metformin therapy
Sitagliptin 100 mg qd (once daily) added on the Metformin therapy
Outcomes
Primary Outcome Measures
Change of HbAlc
Secondary Outcome Measures
HbA1c Responder Rate
responder rate of HbA1c <7%, <6.5% at week 24
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01602003
Brief Title
Phase III Trial to Evaluate the Efficacy and Safety of LC15-0444 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes
Official Title
A Multicenter, Multinational, Randomized, Active-controlled, Parallel Group, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of LC15-0444 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Alone
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences
4. Oversight
5. Study Description
Brief Summary
Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group study The study was divided into three parts: part 1 was a screening period started with an initial 2 weeks of exercise/diet program; part 2 was a double-blind treatment period during which eligible patients were randomized to Sitagliptin 100 mg qd (once daily), LC15-0444 25 mg bid (twice daily), or LC15-0444 50 mg qd 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 50 mg qd.
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, eligible patients were assigned one of three treatment groups with 1:1:1 ratio. During the total of 24-week treatment period of part 2, each patient visited the study site at Week 6, 12, 18, and 24. Completing double-blind treatment for 24 weeks, 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 50 mg once daily. During 28-week treatment period of the part 3, each patient visited the study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
425 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LC15-0444 25 mg bid
Arm Type
Experimental
Arm Description
LC15-0444 25 mg bid(twice daily)added on Metformin therapy
Arm Title
LC15-0444 50 mg qd
Arm Type
Experimental
Arm Description
LC15-0444 50 mg qd(once daily) added on Metformin therapy
Arm Title
Sitagliptin 100mg qd
Arm Type
Active Comparator
Arm Description
Sitagliptin 100 mg qd (once daily) added on the Metformin therapy
Intervention Type
Drug
Intervention Name(s)
LC15-0444 25mg bid
Intervention Description
Each patient was given 3 different bottles of study drugs that comprised of two morning bottles and one evening bottles. Each morning bottle contained LC15-0444 25 mg or 50 mg or Sitagliptin 100mg(depending on the randomized group) or its matching placebo while the evening bottle contained LC15-0444 25 mg or its matching placebo. Patient was instructed to take 1 tablet from each bottle at regular times in the morning and evening every day during the 24-week double-blind treatment period.
Intervention Type
Drug
Intervention Name(s)
LC15-0444 50mg qd
Intervention Description
Each patient was given 3 different bottles of study drugs that comprised of two morning bottles and one evening bottles. Each morning bottle contained LC15-0444 25 mg or 50 mg or Sitagliptin 100mg(depending on the randomized group) or its matching placebo while the evening bottle contained LC15-0444 25 mg or its matching placebo. Patient was instructed to take 1 tablet from each bottle at regular times in the morning and evening every day during the 24-week double-blind treatment period.
Intervention Type
Drug
Intervention Name(s)
Sitagliptin 100mg qd
Intervention Description
Each patient was given 3 different bottles of study drugs that comprised of two morning bottles and one evening bottles. Each morning bottle contained LC15-0444 25 mg or 50 mg or Sitagliptin 100mg(depending on the randomized group) or its matching placebo while the evening bottle contained LC15-0444 25 mg or its matching placebo. Patient was instructed to take 1 tablet from each bottle at regular times in the morning and evening every day during the 24-week double-blind treatment period.
Primary Outcome Measure Information:
Title
Change of HbAlc
Time Frame
from baseline to Week 24
Secondary Outcome Measure Information:
Title
HbA1c Responder Rate
Description
responder rate of HbA1c <7%, <6.5% at week 24
Time Frame
at Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Type 2 Diabetes Mellitus
Adults between 18 and 75 years of age
Patients with HbA1c between 7% and 11%
Patients treated with metformin monotherapy for at least 12 weeks and treated with 1000 mg/day or higher dose of metformin for at least 4 weeks right before 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 60 ml/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 with history of hypersensitivity to thiazolidinediones
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Woo Kim, MD, PhD
Organizational Affiliation
Kangbuk Samsung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
LG Life Sciences
City
Seoul
ZIP/Postal Code
110-062
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Phase III Trial to Evaluate the Efficacy and Safety of LC15-0444 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes
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