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
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
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
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Seoul、大韓民国、110-062
- LG Life Sciences
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：LC15-0444 25 mg bid
LC15-0444 25 mg bid(twice daily)added on Metformin therapy
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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.
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実験的：LC15-0444 50 mg qd
LC15-0444 50 mg qd(once daily) added on Metformin therapy
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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.
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アクティブコンパレータ：Sitagliptin 100mg qd
Sitagliptin 100 mg qd (once daily) added on the Metformin therapy
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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HbAlcの変化
時間枠：ベースラインから24週目まで
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ベースラインから24週目まで
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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HbA1c Responder Rate
時間枠：at Week 24
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responder rate of HbA1c <7%, <6.5% at week 24
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at Week 24
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Sun Woo Kim, MD, PhD、Kangbuk Samsung Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- LG-DPCL006
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2型糖尿病の臨床試験
LC15-0444 25mg bidの臨床試験
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LG Chem完了
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Euthymics BioScience, Inc.完了
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EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, Germany完了関節リウマチセルビア, ウクライナ, アメリカ, チェコ, ポーランド, アルゼンチン, メキシコ, 南アフリカ, チリ, ブルガリア, コロンビア, ロシア連邦