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

NCT01602003 | Completed Phase 3

• 1 other identifier: LG-DPCL006
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change of HbAlc

  from baseline to Week 24

Secondary Outcomes (1)

• HbA1c Responder Rate

  at Week 24

Study Arms (3)

LC15-0444 25 mg bid

EXPERIMENTAL

LC15-0444 25 mg bid(twice daily)added on Metformin therapy

Drug: LC15-0444 25mg bid

LC15-0444 50 mg qd

EXPERIMENTAL

LC15-0444 50 mg qd(once daily) added on Metformin therapy

Drug: LC15-0444 50mg qd

Sitagliptin 100mg qd

ACTIVE COMPARATOR

Sitagliptin 100 mg qd (once daily) added on the Metformin therapy

Drug: Sitagliptin 100mg qd

Interventions

LC15-0444 25mg bid DRUG

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.

LC15-0444 25 mg bid

LC15-0444 50mg qd DRUG

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.

LC15-0444 50 mg qd

Sitagliptin 100mg qd DRUG

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.

Sitagliptin 100mg qd

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (1)

LG Life Sciences

Seoul, 110-062, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LC15-0444; BID protein, human; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Sun Woo Kim, MD, PhD

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: May 18, 2012
• Study Start: December 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: May 1, 2012
• Last Updated: May 18, 2012

Record last verified: 2012-05

Locations

KR (1)