Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice
2019年1月23日 更新者：Takeda
A Prospective, Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice
The purpose of this study is to observe alogliptin and alogliptin fixed-dose combinations (FDCs) utilization patterns, as well as clinical response to treatment with alogliptin or alogliptin FDCs, in standard clinical practice.
調査の概要
状態
終了しました
条件
詳細な説明
The drug being studied in this study is called alogliptin and alogliptin FDCs. Alogliptin and alogliptin FDCs is being researched to treat people who have diabetes mellitus type 2. This study will look at the glycosylated hemoglobin (HbA1c) level dynamics in participants with diabetes mellitus type 2.
The study enrolled 593 patients. Alogliptin and alogliptin FDCs will be prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study).
This multi-center study will be conducted in China. The overall duration of study for observation will be approximately 6 months, or up to loss to follow-up or death, whichever occurs first. Participants will make multiple visits to the clinic as per regular doctor's appointments.
研究の種類
観察的
入学 (実際)
593
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
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
サンプリング方法
非確率サンプル
調査対象母集団
Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.
説明
Inclusion Criteria:
- Has a diagnosis of T2DM.
- Has made the decision, along with his/her treating physician, to begin treatment with alogliptin or alogliptin fixed-dose combinations (FDCs).
- Has an glycated hemoglobin (HbA1c) value recorded at most 3 months before initiation of treatment with alogliptin or alogliptin FDCs.
- Alogliptin or alogliptin FDCs is prescribed according to the approved label for China and Hong Kong.
Exclusion Criteria:
- Has gestational diabetes or type 1 diabetes mellitus.
- Has used Dipeptidyl peptidase-4 inhibitors (DPP-IV inhibitors) or Glucagon like peptide-1 agonists (aGLP-1) within the 3 months prior to the start of alogliptin or alogliptin FDCs treatment.
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
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.
|
アログリプチン錠
Alogliptin FDC with pioglitazone tablets
Alogliptin FDC with metformin tablets
|
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 |
|---|---|---|
|
6か月目のグリコシル化ヘモグロビン（HbA1c）レベルのベースラインからの変化
時間枠：ベースラインと月 6
|
グリコシル化ヘモグロビンの値の変化 (ヘモグロビンに結合できる絶対最大値のパーセントとしてのヘモグロビンに結合したグルコースの濃度) は、ベースラインと比較して 6 か月目に収集されました。
糖尿病の診断基準となる糖化ヘモグロビン（HbA1c）は6.5%以上です。
ベースラインからのマイナスの変化は改善を示します。
|
ベースラインと月 6
|
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 Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics
時間枠：Baseline and Month 6
|
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline.
Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%.
Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control.
A negative change from Baseline indicates improvement.
|
Baseline and Month 6
|
|
Percentage of Participants With a Decrease in HbA1c Level by <7.0%
時間枠：Baseline and Month 6
|
Percentage of participants with a decrease of <7.0% from baseline in HbA1c were reported.
|
Baseline and Month 6
|
|
Percentage of Participants With a Decrease in HbA1c Level by >0.3% and No Tolerability Findings
時間枠：Baseline and Month 6
|
Percentage of participants with a decrease of >0.3% from baseline in HbA1c along with no tolerability findings were reported.
Tolerability findings included hypoglycemic event, or weight gain ≥5%.
|
Baseline and Month 6
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time
時間枠：Baseline and Months 3 and 6
|
The change between the fasting plasma glucose value collected at Months 3 and 6 relative to baseline.
A negative change from Baseline indicates improvement.
|
Baseline and Months 3 and 6
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time
時間枠：Baseline and Months 3 and 6
|
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Months 3 and 6 relative to baseline.
A negative change from Baseline indicates improvement.
|
Baseline and Months 3 and 6
|
|
Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
時間枠：Baseline up to Month 6
|
An ADR is defined as any response to a medicinal product that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of diseases or for the restoration, correction, or modification of physiological function.
An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Adverse events such as pancreatitis, hepatic disorders, and hypersensitivity reactions (including angioedema, anaphylaxis, and Stevens-Johnson syndrome) were considered as AESI.
|
Baseline up to Month 6
|
|
Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs
時間枠：Months 3 and 6
|
Months 3 and 6
|
|
|
Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction
時間枠：Months 3 and 6
|
Months 3 and 6
|
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
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)
2016年12月22日
一次修了 (実際)
2018年1月26日
研究の完了 (実際)
2018年1月26日
試験登録日
最初に提出
2016年12月8日
QC基準を満たした最初の提出物
2016年12月8日
最初の投稿 (見積もり)
2016年12月12日
学習記録の更新
投稿された最後の更新 (実際)
2019年4月19日
QC基準を満たした最後の更新が送信されました
2019年1月23日
最終確認日
2019年1月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- Alogliptin-5009
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
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach
for details).
To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias.
Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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