短期集中デエスカレーション療法が長期レジメンの簡素化に及ぼす影響
コントロール不良の2型糖尿病患者における長期レジメン簡素化に対する短期集中緩和療法の効果 -- 多施設共同、非盲検、ランダム化対照試験
Despite advances in diabetes management, many patients with type 2 diabetes in China fail to achieve optimal glycemic control. One of the possible reasons is associated with the delay in therapeutic decision making that lags behind glycemic rise. The investigators design this study and presume that using vildagliptin and metformin in combination with basal insulin as sequential treatment after intensive insulin therapy, might better modulate the dual islet hormone dysfunction than traditionally stepwise upgrading therapy pattern in patients with poorly controlled T2DM, and thus lead to a glucose normalization, β-cell function improvement and therapy simplification.
調査の概要
状態
条件
詳細な説明
This is a multicenter, randomized, controlled, open-label, clinical superiority trial. The participants will be recruited from 10 centers in China. The enrolled participants will be randomly assigned into 3 groups.
Group CIW (CSII with wearables):Continuous subcutaneous insulin infusion (CSII) will be applied to the participants for 1-2 weeks and thereafter the combination therapy of basal insulin, metformin and vildagliptin for the next 10 weeks and then insulin will be suspended. The participants are wearing wearables.
Group CI (CSII without wearbles): CSII will be applied to the participants for 1-2 weeks and thereafter the combination therapy of basal insulin, metformin and vildagliptin for the next 10 weeks and then insulin will be suspended.
Group BI (Basal insulin treatment): The participants will be applied the combination therapy of basal insulin, vildagliptin and metformin for the entire 12 weeks and then insulin will be suspended.
Participants will then receive combination therapy of metformin and vildagliptin. If the participants cannot tolerate metformin, then acarbose (50-100mg tid) or SGLT2 inhibitor can be instead used. If glucose is not well controlled, sulfonylureas or glinides can be added as a rescue treatment.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510080
- Department of endocrinology, FAH-SYSU
-
-
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:
-
Type 2 diabetes diagnosed according to WHO criteria (1999); With a duration of 1~15 years;
-
With two or more oral hypoglycemic drugs, or basal insulin and 1-2 oral hypglycemic agents, used for at least 3 months;
-
HbA1c of 7.5 to 13% and fasting C-peptide > 0.4 nmol/L;
-
Age of 18 to 70 years;
-
BMI of 20 to 35 kg/m²;
-
Capable of and willing to follow doctors' instructions to:
-
Self-monitor blood glucose according to the protocol;
- Follow the protocol and have regular visits as required; ③ Record and maintain the research diary, as required by the protocol; ④ Keep contact with the investigators and receive phone calls during the study.
-
Exclusion Criteria:
- Type 1 diabetes or specific types of diabetes;
- Those who have received premixed insulin therapy and/or basal - meal insulin and/or basal insulin-oral hypoglycemic agents treatment accumulation for 7 days or more, and those who have received CSII therapy in the last one year, and those who have received GLP-1 analogue within 3 months before screening;
- Those who have acute diabetic complications (diabetic ketoacidosis, hyperosmotic hyperglycemia coma or lactic acidosis);
- Those who have severe diabetic microvascular complications (proliferative retinopathy, clinical proteinuria, and glomerular filtration rate less than 45 ml/min, uncontrolled diabetic neuropathy and obvious diabetic autonomic neuropathy);
- Those with ALT >2.5 times of the upper limit of normal (ULN), bilirubin > 1.5 times of ULN;
- Those with known macrovascular disease: Patients with acute cerebrovascular accident, acute coronary syndrome, unstable angina, peripheral artery disease who have received vascular intervention or amputation in the 12 months before enrollment; Or chronic cardiac dysfunction with cardiac function grade III or above;
- Those with poor blood pressure control (systolic blood pressure≥160mmHg and/or sitting diastolic blood pressure ≥110mmHg) and inability to control under 160/110mmhg within 1 week;
- Serious systemic disease or malignant tumor, chronic diarrhea, etc;
- Those with drugs that may affect blood glucose for a cumulative time of more than 1 week within 12 weeks, such as oral/venous glucocorticoid, growth hormone, estrogen/ progesterone, high-dose diuretics, antipsychotic drugs. However, low-dose diuretics for antihypertensive purposes (HCTZ < 25mg/d, indapamide < 1.5mg/d) and physiologic dose of thyroid hormone for replacement therapy are not included;
- Any factors that may affect the participation of the subject in the study or the evaluation of the results;
- Pregnancy or planned pregnancy, lactation subjects.
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:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:CSII with wearables
Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin will be applied. Then the oral hypoglycemic therapies will be prescribed. Wearable devices will be used. |
Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin; Wearable devices will be used during the follow-up. |
|
実験的:CSII without wearbles
Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin will be applied. Then the oral hypoglycemic therapies will be prescribed. |
Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin. |
|
アクティブコンパレータ:Basal insulin group
The combination therapy of basal insulin, metformin and vildagliptin for the entire 12 weeks and thereafter the oral hypoglycemic therapies will be applied. |
The participants will be applied the combination therapy of basal insulin, metformin and vildagliptin for the entire 12 weeks. |
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 |
|---|---|---|
|
the proportions of treatment de-escalation
時間枠:From enrollment to the end of treatment at week 36
|
the proportions of patients who can use only combination of two oral hypoglycemic agents |
From enrollment to the end of treatment at week 36
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Yanbing Li, Dr、FAH-SYSU
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2018YFC1314103
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。