A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients
2011年5月11日 更新者：Eli Lilly and Company
A Prospective Randomized Trial to Compare Basal Bolus Therapies That Use Either Insulin Lispro Protamine Suspension or Insulin Glargine Together With Lispro Insulin in Patients With Type 2 Diabetes
This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
374
段階
- フェーズ 3
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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Scotland
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Edinburgh、Scotland、イギリス、EH3 9YW
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South Yorkshire
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Sheffield、South Yorkshire、イギリス、S5 7AU
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Warwickshire
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Rugby、Warwickshire、イギリス、CV22 5PX
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West Midlands
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West Bromwich、West Midlands、イギリス、B71 4HJ
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Ancona、イタリア、60131
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Bari、イタリア、70124
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Milano、イタリア、20162
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Padova、イタリア、35143
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Pistoia、イタリア、51100
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Ravenna、イタリア、48100
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Rome、イタリア、00189
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Athens、ギリシャ、11526
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Larissa、ギリシャ、41221
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Thessaloniki、ギリシャ、56429
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Banska Bystrica、スロバキア、97405
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Bratislava、スロバキア、821 06
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Modra、スロバキア、900 01
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Nitra、スロバキア、94901
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Holesov、チェコ共和国、769 01
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Hranice I-Mesto、チェコ共和国、753 01
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Olomouc、チェコ共和国、77200
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Ostrava、チェコ共和国、709 00
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Plzen、チェコ共和国、301 66
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Prague、チェコ共和国、149 00
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Bad Mergentheim、ドイツ、D-97980
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Berlin、ドイツ、D-12351
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Damme、ドイツ、D-49401
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Dresden、ドイツ、D-01219
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Hamburg、ドイツ、D-22177
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Hannover、ドイツ、30519
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Pirna、ドイツ、01796
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Rotenburg-Fulda、ドイツ、D-36199
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Genk、ベルギー、3600
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Leuven、ベルギー、3000
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Willebroek、ベルギー、2830
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Gorzow Wielkopolski、ポーランド、66-400
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Krakow、ポーランド、31-159
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Lodz、ポーランド、93-338
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Lubin、ポーランド、59-301
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Mielec、ポーランド、39-300
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Poznan、ポーランド、61-696
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Warsaw、ポーランド、02-577
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Wroclaw、ポーランド、503-349
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Baia Mare、ルーマニア、430071
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Bucharest、ルーマニア、020475
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Cluj-Napoca、ルーマニア、400006
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Sf Gheorghe、ルーマニア
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Bornova、七面鳥、35100
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Istanbul、七面鳥、34662
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Izmir、七面鳥、35360
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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
説明
Inclusion Criteria:
- Diabetes Mellitus, Type 2
- Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)
- Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%
- Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m^2
- Capable and willing to follow the protocol
- Give written consent
Exclusion Criteria:
- Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)
- Have a history of severe hypoglycemia in the past 6 months
- Are pregnant or may become pregnant
- Women who are breastfeeding
- Have significant cardiac disease
- Have significant renal or liver disease
- Undergoing therapy for a malignancy
- Contraindications to the study medications
- Have an irregular sleep/wake cycle
- Have a serious disease or any condition considered by the investigator to be exclusionary
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：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 |
|---|---|
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アクティブコンパレータ：Glargine
Glargine plus Insulin Lispro (2-3 injections)
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patient glucose-level dependent, injection, once daily in the evening, 24 weeks
subcutaneous injections prior to meals, 24 weeks
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実験的：ILPS
Insulin Lispro Protamine Suspension (ILPS) plus Insulin Lispro (2-3 injections)
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subcutaneous injections prior to meals, 24 weeks
patient glucose-level dependent, injection, once daily in the evening, 24 weeks
他の名前：
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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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Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24
時間枠：Baseline, Week 24
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Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.
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Baseline, Week 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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Change From Baseline in HbA1c at Week 12 and Week 24
時間枠：Baseline, Week 12, Week 24
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LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.
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Baseline, Week 12, Week 24
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Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint
時間枠：Week 24
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Week 24
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7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint
時間枠：24 weeks
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LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours.
Postprandial glucose is measured 2 hours after the start of the meal.
|
24 weeks
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Glycemic Variability at Endpoint
時間枠：Week 24
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LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe).
Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements.
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Week 24
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Rate Of All Self-reported Hypoglycemic Episodes
時間枠：Baseline through Week 24
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Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L.
Rate=episodes/30 days/patient/.
Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period.
Nocturnal=Episode between bedtime and waking.
Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
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Baseline through Week 24
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Percentage of Participants With Self-Reported Hypoglycemic Episodes
時間枠：Baseline through Week 24
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Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment.
Overall=any time post-randomization visits in the study period.
Nocturnal=Episode that occurs between bedtime and waking.
Non-Nocturnal=Episode occurring between waking and bedtime.
Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
|
Baseline through Week 24
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Number of Participants With Adverse Events (AE)
時間枠：Baseline through Week 24
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A listing of adverse events is located in the Reported Adverse Event module.
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Baseline through Week 24
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Change in Body Weight From Baseline to Week 24
時間枠：Baseline, Week 24
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LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
|
Baseline, Week 24
|
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Total Daily Insulin Dose at Endpoint
時間枠：Week 24
|
LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
|
Week 24
|
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Number of Injections of Insulin at Week 24
時間枠：Week 24
|
Week 24
|
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
2008年4月1日
一次修了 (実際)
2010年2月1日
研究の完了 (実際)
2010年2月1日
試験登録日
最初に提出
2008年4月23日
QC基準を満たした最初の提出物
2008年4月23日
最初の投稿 (見積もり)
2008年4月25日
学習記録の更新
投稿された最後の更新 (見積もり)
2011年5月13日
QC基準を満たした最後の更新が送信されました
2011年5月11日
最終確認日
2011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。
2型糖尿病の臨床試験
Insulin Glargineの臨床試験
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Julphar Gulf Pharmaceutical IndustriesParexel; Profil Institut für Stoffwechselforschung GmbH完了
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Julphar Gulf Pharmaceutical IndustriesProfil Institut für Stoffwechselforschung GmbH完了
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Sanofi終了しました
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Emory UniversityBoston Medical Center; Rush University; University of Denver完了
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Emory UniversityMerck Sharp & Dohme LLC; University of Michigan; Temple University; Ohio University完了