Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022)
2018年8月9日 更新者：Merck Sharp & Dohme LLC
A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin
This study will examine the safety and efficacy of the addition of omarigliptin in participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and glimepiride.
The primary hypothesis is that after 24 weeks, the addition of treatment with omarigliptin provides a greater reduction in hemoglobin A1c (A1C) compared with the addition of placebo.
調査の概要
研究の種類
介入
入学 (実際)
307
段階
- フェーズ 3
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Diagnosed with type 2 diabetes mellitus
- Currently taking stable doses of metformin (>=1500 mg/day) and sulfonylurea
- Male, or female not of reproductive potential or female of reproductive potential who agrees to remain abstinent or use (or have their partner use) 2 methods of acceptable contraception to prevent pregnancy during the study and for 21 days after the last dose of study drug
Exclusion Criteria:
- History of type 1 diabetes mellitus or a history of ketoacidosis
- Treated with any antihyperglycemic agent therapies other than the protocol-required sulfonylurea and metformin within 12 weeks prior to study participation or with omarigliptin at any time prior to study participation.
- History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor
- On a weight loss program and is not in the maintenance phase; or has been on a weight loss medication in the past 6 months; or has undergone bariatric surgery within 12 months prior to study participation.
- Is on or likely to require treatment for >=2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal or topical corticosteroids are permitted)
- Currently being treated for hyperthyroidism or is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks
- Medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
- Human immunodeficiency virus (HIV)
- New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke, or transient ischemic neurological disorder within the past 3 months
- Poorly controlled hypertension
- History of malignancy <=5 years prior to study participation, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- Clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
- Pregnant or breast feeding, or is expecting to conceive or donate eggs during the trial, including 21 days following the last dose of study drug
- Current user of recreational or illicit drugs or has had a recent history of drug abuse or routinely consumes >2 alcoholic drinks per day or >14 drinks per week, or engages in binge drinking
- Donated blood products within 8 weeks of study participation, or intends to donate blood products during the study or has received or anticipates receiving blood products within 12 weeks prior to study participation or during the study
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Omarigliptin
Omarigliptin (MK-3102) 25 mg capsule administered orally once a week for 24 weeks.
Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
|
Omarigliptin 25 mg capsule administered orally once a week
Open-label glimepiride tablet(s) administered orally once daily for a total daily dose >=4 mg.
In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.
他の名前：
Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose >=1500 mg
他の名前：
|
|
プラセボコンパレーター：Placebo
Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks.
Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
|
Open-label glimepiride tablet(s) administered orally once daily for a total daily dose >=4 mg.
In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.
他の名前：
Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose >=1500 mg
他の名前：
Matching placebo to omarigliptin capsule administered orally once a week
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (A1C) at Week 24
時間枠：Baseline and Week 24
|
A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%).
Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.
|
Baseline and Week 24
|
|
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
時間枠：Up to Week 27
|
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
Up to Week 27
|
|
Percentage of Participants Who Discontinued From the Study Due to an AE
時間枠：Up to Week 24
|
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
|
Up to Week 24
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
時間枠：Baseline and Week 24
|
Blood glucose was measured on a fasting basis.
FPG is expressed as mg/dL.
Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).
|
Baseline and Week 24
|
|
Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24
時間枠：24 weeks
|
The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) or <7.0%
(53 mmol/mol) in the FAS population at Week 24.
|
24 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2012年10月18日
一次修了 (実際)
2014年12月23日
研究の完了 (実際)
2014年12月23日
試験登録日
最初に提出
2012年10月8日
QC基準を満たした最初の提出物
2012年10月8日
最初の投稿 (見積もり)
2012年10月11日
学習記録の更新
投稿された最後の更新 (実際)
2018年9月10日
QC基準を満たした最後の更新が送信されました
2018年8月9日
最終確認日
2018年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 3102-022
- 2012-002612-10 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
試験データ・資料
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。