CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy
2015年3月20日 更新者：AstraZeneca
CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy - A European Observational Study of Patients With Type 2 Diabetes Initiating Injectable Therapy to Determine Time to Treatment Change, Factors Associated With Treatment Changes and Outcomes Over 24 Months
Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimens are being modified, what treatment modifications are made, and clinical and patient-reported outcomes.
調査の概要
状態
完了
条件
研究の種類
観察的
入学 (実際)
2515
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。
研究場所
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Kozani、ギリシャ
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N. Efkarpia、ギリシャ
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Thessaloniki、ギリシャ
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Veroia、ギリシャ
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Angelholm、スウェーデン
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Angered、スウェーデン
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Dalby、スウェーデン
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Falun、スウェーデン
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Goteborg、スウェーデン
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Limhamn、スウェーデン
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Lulea、スウェーデン
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Malmo、スウェーデン
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Skivarp、スウェーデン
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Skovde、スウェーデン
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Stockholm、スウェーデン
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Vadstena、スウェーデン
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Vastervik、スウェーデン
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Amager、デンマーク
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Ronne、デンマーク
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Alsfeld、ドイツ
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Aschaffenburg、ドイツ
- Research
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Asslar、ドイツ
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Augsburg、ドイツ
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Bad Aibling、ドイツ
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Bad Homburg、ドイツ
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Bad Mergentheim、ドイツ
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Bergheim、ドイツ
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Berlin、ドイツ
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Birkenfeld、ドイツ
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Bosenheim、ドイツ
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Bruchsal、ドイツ
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Dortmund、ドイツ
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Dresden、ドイツ
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Duisburg、ドイツ
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Eberswalde、ドイツ
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Eilenburg、ドイツ
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Eisenach、ドイツ
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Erfurt、ドイツ
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Essen、ドイツ
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Frankfurt、ドイツ
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Gebhardshain、ドイツ
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Gersfeld、ドイツ
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Giessen、ドイツ
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Gifhorn、ドイツ
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Grassau、ドイツ
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Gross-Gerau、ドイツ
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Hadmersleben、ドイツ
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Halle、ドイツ
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Hamburg、ドイツ
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Hammelburg、ドイツ
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Hennigsdorf、ドイツ
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Hohenmolsen、ドイツ
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Ismaning、ドイツ
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Kothen、ドイツ
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Kutenholz、ドイツ
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Langen、ドイツ
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Langenfeld、ドイツ
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Leipzig、ドイツ
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Lichtenfels、ドイツ
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Ludwigsburg、ドイツ
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Luneburg、ドイツ
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Marburg、ドイツ
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Mayen、ドイツ
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Meissen、ドイツ
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Minden、ドイツ
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Monchengladbach、ドイツ
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Munchen、ドイツ
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Munster、ドイツ
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Nassau、ドイツ
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Netphen、ドイツ
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Oberhausen、ドイツ
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Pirmasens、ドイツ
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Recklinghausen、ドイツ
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Rehburg-Loccum、ドイツ
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Reichenbach、ドイツ
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Riesa、ドイツ
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Saarbrucken、ドイツ
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Saarlouis、ドイツ
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Schkeuditz、ドイツ
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Schonwalde、ドイツ
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Schweinfurt、ドイツ
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Seligenstadt、ドイツ
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Siegen、ドイツ
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Stockach、ドイツ
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Thale、ドイツ
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Ubach-Palenberg、ドイツ
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Ueckermunde、ドイツ
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Villingen-Schwenningen、ドイツ
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Volklingen、ドイツ
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Warburg、ドイツ
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Weissenberg、ドイツ
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Werl、ドイツ
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Westfalica、ドイツ
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Wilhelmshaven、ドイツ
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Wurzen、ドイツ
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Toul Cedex、フランス
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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
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
The study population consisted of patients aged 18 or above, with type 2 diabetes starting any of the available initial injectable treatment options (any insulin, or exenatide BID) for the treatment of type 2 diabetes as part of routine clinical care.
説明
Inclusion Criteria:
- are aged 18 or above
- diagnosed with type 2 diabetes
- have had a treatment decision made within the normal course of care to initiate either insulin or exenatide for the treatment of type 2 diabetes
- have not previously been treated with either insulin or exenatide
- are not simultaneously participating in another study which includes an investigational drug or procedure at study entry
- have been fully informed and given their written consent for use of their data
- have sufficient understanding of the primary language of their country such that they will be able to complete the questionnaires.
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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1
exenatide
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皮下注射、5mcgまたは10mcg、1日2回
他の名前：
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2
insulin
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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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Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
時間枠：Month 24
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The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time. Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study. Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following: Insulin:
Exenatide:
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Month 24
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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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Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
時間枠：Baseline
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Higher BMI was one of the Factors evaluated for association with treatment choice at baseline.
BMI was calculated as body weight in kilograms (kg) divided by height in meters (m) squared (kg/m^2).
The mean BMI at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for BMI=1 kg/m^2 higher.
Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes.
Baseline was Visit T1 (prior to start of treatment).
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Baseline
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Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline
時間枠：Baseline
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Higher HbA1c was one of the Factors evaluated for association with treatment choice at baseline.HbA1c was reported in percent of hemoglobin.
The mean HbA1c at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for HbA1c=1% higher.
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Baseline
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Older Age Associated With Treatment Choice at Baseline
時間枠：Baseline
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Older age (1 year older) was one of the Factors evaluated for association with treatment choice at baseline.
The mean age at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for age 1 year older.
Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes.
Baseline was Visit T1 (prior to start of treatment).
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Baseline
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Disinhibited Eating Associated With Treatment Choice at Baseline
時間枠：Baseline
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Diabetes Health Profile (DHP-18) - consists of 18 items across 3 domains (psychological distress, barriers to activity, and disinhibited eating), with each item standardized score rated from 0-100; 0=no dysfunction, higher numbers=greater dysfunction.
The subscale of disinhibited eating was one of the Factors evaluated for association with treatment choice at baseline.
The number of participants with disinhibited eating at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for disinhibited eating.
Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes.
Baseline was Visit T1 (prior to start of treatment).
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Baseline
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Higher Random Glucose Associated With Treatment Choice at Baseline
時間枠：6 months prior to Baseline
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Random Glucose 1 millimole per liter (mmol/L) higher was one of the Factors evaluated for association with treatment choice at baseline.
Random glucose is a glucose within the last 6 months prior to baseline.
The mean is provided below and the statistical analysis provides the 2 arms odds ratio for the glucose 1 mmol/L higher.
Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes.
Baseline was Visit T1 (prior to start of treatment).
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6 months prior to Baseline
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Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline
時間枠：4 weeks prior to Baseline
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Frequent glucose self-testing (1 test/week more) was one of the Factors evaluated for association with treatment choice at baseline.
The mean number of self monitoring blood glucose tests per week over the last 4 weeks prior to baseline was determined at baseline and is provided below.
The statistical analysis provides the 2 arms odds ratio.
Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes.
Baseline was Visit T1 (prior to start of treatment).
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4 weeks prior to Baseline
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Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline
時間枠：Baseline
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Receipt of diet and exercise advice was one of the Factors evaluated for association with treatment choice at baseline.
The number of participants who checked yes or no during the baseline visit for prior receipt of diet/exercise advice in his/her Diabetes management is provided below and the statistical analysis provides the 2 arms odds ratio.
Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes.
Baseline was Visit T1 (prior to start of treatment).
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Baseline
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Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline
時間枠：Baseline
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Higher (1 mmol/L higher) LDL cholesterol was one of the Factors evaluated for association with treatment choice at baseline.
The mean LDL cholesterol at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for 1 mmol/L higher at baseline.
Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes.
Baseline was Visit T1 (prior to start of treatment).
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Baseline
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Changes in HbA1c From Baseline to Month 24
時間枠：Baseline, Month 24
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Changes in HbA1c From Baseline to Month 24
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Baseline, Month 24
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Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24
時間枠：Month 24
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Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24.
Only patients with baseline HbA1c >= 7.0 % were included in this analysis
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Month 24
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Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24
時間枠：Month 24
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Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24.
Note: Only patients with baseline HbA1c >=6.5% were included in this analysis.
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Month 24
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Changes in Weight From Baseline to Month 24
時間枠：Baseline, Month 24
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Changes in Weight From Baseline to Month 24
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Baseline, Month 24
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Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months
時間枠：Baseline to Month 24
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Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months
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Baseline to Month 24
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Incidence of Hypoglycemia Between Baseline and 24 Months
時間枠：Baseline to Month 24
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Incidence of Hypoglycemia between Baseline and 24 Months
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Baseline to Month 24
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Reasons for Discontinuation of Baseline Regimen
時間枠：Baseline to Month 24
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Reasons for Discontinuation of Baseline Regimen
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Baseline to Month 24
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Factors Associated With Treatment Change in Insulin Cohort
時間枠：Baseline to Month 24
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Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort
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Baseline to Month 24
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Factors Associated With Treatment Change in Exenatide BID Cohort
時間枠：Baseline to Month 24
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Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Exenatide BID cohort.
EQ-5D (Health Questionnaire Copyright @ Euro QoL Group 1998).
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Baseline to Month 24
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Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months
時間枠：Baseline to Month 24
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Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months
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Baseline to Month 24
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Number of Contacts With Health Care Providers Between Baseline and 24 Months
時間枠：Baseline to Month 24
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Number of contacts with Health Care Providers Between Baseline and 24 Months
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Baseline to Month 24
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Percentage of Patients Hospitalized Between Baseline and 24 Months
時間枠：Baseline to Month 24
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Percentage of Patients Hospitalized Between Baseline and 24 Months
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Baseline to Month 24
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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。
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。
一般刊行物
- Schultheis P, Montoya MN, Zhao Q, Archer J, Madden T, Peipert JF. Contraception and ectopic pregnancy risk: a prospective observational analysis. Am J Obstet Gynecol. 2021 Feb;224(2):228-229. doi: 10.1016/j.ajog.2020.10.013. Epub 2020 Oct 10. No abstract available.
- Reaney M, Mathieu C, Ostenson CG, Matthaei S, Krarup T, Kiljanski J, Salaun-Martin C, Sapin H, Theodorakis M, Guerci B. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study. Health Qual Life Outcomes. 2013 Dec 26;11:217. doi: 10.1186/1477-7525-11-217.
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
2008年1月1日
一次修了 (実際)
2011年12月1日
研究の完了 (実際)
2011年12月1日
試験登録日
最初に提出
2008年2月20日
QC基準を満たした最初の提出物
2008年3月12日
最初の投稿 (見積もり)
2008年3月13日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年4月9日
QC基準を満たした最後の更新が送信されました
2015年3月20日
最終確認日
2015年3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。