Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems (Hybrid CATT1)
2026年5月22日 更新者：vTv Therapeutics
Hybrid CATT1: Hybrid Closed Loop Insulin Pumps With Cadisegliatin as Adjunctive Treatment in Patients With Type 1 Diabetes A Phase 2a Double Blind Randomized Cross-Over Study
TTP399-206 is a Phase 2a multicenter double blind cross over randomized study of cadisegliatin in participants with T1D using hybrid closed loop systems to manager their diabetes.
Patients using a hybrid closed loop insulin pump to manage their diabetes will be randomized to either receive blinded cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment or placebo QD along with their insulin treatment.
The trial begins with a screening period of up to 2 weeks, followed by a device training and insulin adjustment period of 1-2 weeks leading into the first double-blind treatment period of 6 weeks.
There will then be a washout period of 1-2 weeks followed by the second double-blind treatment period of 6 weeks where the patient will cross-over to the treatment arm that they did not receive in the first treatment period.
調査の概要
詳細な説明
TTP399-206 is a 20 week, Phase 2a trial designed to evaluate efficacy and safety of cadisegliatin in participants with T1D who are using hybrid closed loop (HCL) systems to manage their condition to gather preliminary data to understand how cadisegliatin performs in an HCL setting.
研究の種類
介入
入学 (推定)
40
段階
- フェーズ2
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。
研究連絡先
- 名前：Meaghan Marnell
- 電話番号：(336) 888-0435
- メール：clinicaltrials@vtvtherapeutics.com
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30318
- Atlanta Diabetes Associates
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主任研究者：
- Bruce W Bode, MD
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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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Key Inclusion Criteria:
- Participants >= 18 years of age
- Fasting plasma C-peptide levels <0.6 ng/ml
- Average TIR < 70% at the end of the screening period
- Currently on a hybrid closed loop device for at least 3 months and willing to stay on the same model of pump device for study duration
- Willing to wear a study provided CGM for study duration
- Capable of participating in a 30-minute lasting exercise test
Key Exclusion Criteria:
- Have Type 2 Diabetes Mellitus (DM), monogenic diabetes, maturity-onset diabetes, other unusual or rare forms of DM, or diabetes resulting from a secondary disease.
- Have been hospitalized for DKA within 3 months
- Have uncontrolled hypothyroidism or hyperthyroidism
- Have QTcF interval > 450 msec for males or > 470 msec for females
- Have a personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias
- Have persistent, uncontrolled hypertension
- Have clinically significant cardiovascular or cerebrovascular disease
- Have proliferative retinopathy or maculopathy requiring acute treatment
- Have a serious concomitant systemic disorder incliuding but not limited to HIV or active Hep B or Hep C
- Diagnosed and/or treated for malignancy within 3 years
- Have used any of the following medications within the specified time periods: any non-insulin anti-diabetic therapies (e.g.SGLT-2 inhibitors, GLP-1 receptor agonists, metformin, sulfonylureas, DPP-4 inhibitors, pramlintide, a-glucosidase inhibitors, or glucose dependent insulinotropic polypeptide agonists) within 30 days, antipsychotic medications (e.g. olanzapine, risperidone, clozapine, quetiapine, and haloperidol) within 30 days, systemic corticosteroids for ≥7 days for a temporary medical condition within 30 days,
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：クロスオーバー割り当て
- 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 |
|---|---|
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実験的：Cadisegliatin 800 mg QD: Double Blind, Randomized Crossover Trial Design
If a patient is randomized to receive cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment in the first double-blind treatment period of 6 weeks, there will then be a washout period of 1-2 weeks followed by the second double-blind treatment period of 6 weeks where the patient will cross-over to the placebo QD along with their insulin treatment arm
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Cadisegliatin is an orally bioavailable small-molecule glucokinase activator, adjunctive therapy to insulin
他の名前：
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プラセボコンパレーター：Placebo: Double Blind, Randomized Crossover Trial Design
If a patient is randomized to receive placebo QD along with their insulin treatment in the first double-blind treatment period of 6 weeks, there will then be a washout period of 1-2 weeks followed by the second double-blind treatment period of 6 weeks where the patient will cross-over to the cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment arm
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プラセボ（インスリンだけ）
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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To assess the change in Time in Range (TIR)
時間枠：last 2 weeks of the two 6-week treatment periods
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Time in Range (TIR) based on study CGM in participants with T1D who are using hybrid closed loop systems on cadisegliatin vs placebo
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last 2 weeks of the two 6-week treatment periods
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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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CGM-based metric for glycemic control
時間枠：last 2 weeks of the two 6-week treatment periods
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Time In Tight Range (TITR)
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last 2 weeks of the two 6-week treatment periods
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CGM-based metric for glycemic control
時間枠：last 2 weeks of the two 6-week treatment periods
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Time Above Range (TAR)
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last 2 weeks of the two 6-week treatment periods
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CGM-based metric for glycemic control
時間枠：last 2 weeks of the two 6-week treatment periods
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Time Below Range (TBR)
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last 2 weeks of the two 6-week treatment periods
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CGM-based metric for glycemic control
時間枠：last 2 weeks of the two 6-week treatment periods
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Glucose Management Indicator (GMI)
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last 2 weeks of the two 6-week treatment periods
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CGM-based metric for glycemic control
時間枠：last 2 weeks of the two 6-week treatment periods
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Glucose variability (GV)
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last 2 weeks of the two 6-week treatment periods
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CGM-based metric for glycemic control
時間枠：last 2 weeks of the two 6-week treatment periods
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Time in Range (TIR) > 70%
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last 2 weeks of the two 6-week treatment periods
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Change in glucose control after standardized mixed meal tolerance test (MMTT)
時間枠：12 weeks
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Glucose Peak Plasma Concentration (Cmax) based on study CGM after standardized mixed meal tolerance test (MMTT)
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12 weeks
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Change in glucose control after standardized mixed meal tolerance test (MMTT)
時間枠：12 weeks
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Glucose Area under the plasma concentration versus time curve (AUC) based on study CGM after standardized mixed meal tolerance test (MMTT)
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12 weeks
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Change in glucose control after a standardized exercise test
時間枠：12 weeks
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Glucose Peak Plasma Concentration (Cmax) based on study CGM after a standardized exercise test
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12 weeks
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Change in glucose control after a standardized exercise test
時間枠：12 weeks
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Glucose Minimum Plasma Concentration (Cmin) based on study CGM after a standardized exercise test
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12 weeks
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Change in glucose control after a standardized exercise test
時間枠：12 weeks
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Glucose Area under the plasma concentration versus time curve (AUC) based on study CGM after a standardized exercise test
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12 weeks
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To assess the change in Level 1, Level 2 , and Level 3 hypoglycemic incidence
時間枠：12 weeks
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Number of events of Level 1, Level 2, and Level 3 hypoglycemia as determined by CGM and adjudicated level 3 hypoglycemic events per patient year in participants with T1D who are using hybrid closed loop systems on cadisegliatin vs placebo
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12 weeks
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Assess incidence of Serious Adverse Events (SAEs)
時間枠：14 weeks
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Number of Serious Adverse Events (SAEs)
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14 weeks
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Assess incidence of Treatment Emergent Adverse Events (TEAEs)
時間枠：14 weeks
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Number of treatment emergent adverse events (TEAEs)
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14 weeks
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Assess incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuation
時間枠：14 weeks
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Number of treatment emergent adverse events (TEAEs) leading to discontinuation of study drug
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14 weeks
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Assess incidence of Adverse Events of Special Interest (AESIs)
時間枠：14 weeks
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Number of adverse events of special interest (AESIs)
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14 weeks
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Change from baseline in average daily total insulin dose
時間枠：last week of the two 6-week treatment periods
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Change from baseline in average daily total insulin dose in units (IU) based on manual entry in eDiary records from participants with T1D who are using hybrid closed loop systems on cadisegliatin vs placebo
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last week of the two 6-week treatment periods
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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
捜査官
- スタディディレクター：Thomas Strack, MD、vTv Therapeutics LLC
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 (推定)
2026年7月1日
一次修了 (推定)
2027年4月1日
研究の完了 (推定)
2027年5月1日
試験登録日
最初に提出
2026年5月15日
QC基準を満たした最初の提出物
2026年5月22日
最初の投稿 (実際)
2026年6月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月1日
QC基準を満たした最後の更新が送信されました
2026年5月22日
最終確認日
2026年5月1日
詳しくは
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。