Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY) (IOOY)
2009年11月4日 更新者：Eli Lilly and Company
Treat-to-Target Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Comparator) in Basal Therapy for Patients With Type 2 Diabetes Mellitus
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes.
A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
調査の概要
研究の種類
介入
入学 (実際)
442
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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Alabama
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Hueytown、Alabama、アメリカ、35023
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Arizona
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Litchfield Park、Arizona、アメリカ、85340
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Phoenix、Arizona、アメリカ、85016
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California
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Buena Park、California、アメリカ、90620
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Fountain Valley、California、アメリカ、92708
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Los Angeles、California、アメリカ、90057
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Florida
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Jacksonville、Florida、アメリカ、32257
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Georgia
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Atlanta、Georgia、アメリカ、30312
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Illinois
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Chicago、Illinois、アメリカ、60612
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Indiana
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Evansville、Indiana、アメリカ、47714
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Indianapolis、Indiana、アメリカ、46202
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Newburgh、Indiana、アメリカ、47630
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Kentucky
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Lexington、Kentucky、アメリカ、40503
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Louisiana
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Slidell、Louisiana、アメリカ、70458
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Maryland
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Prince Frederick、Maryland、アメリカ、20678
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Michigan
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Novi、Michigan、アメリカ、48374
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Nevada
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Las Vegas、Nevada、アメリカ、89101
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New York
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Syracuse、New York、アメリカ、13210
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North Carolina
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Goldsboro、North Carolina、アメリカ、27530
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Ohio
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Cincinnati、Ohio、アメリカ、45236
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London、Ohio、アメリカ、43140
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Oregon
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Bend、Oregon、アメリカ、97701
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Pennsylvania
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Lansdale、Pennsylvania、アメリカ、19446
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South Carolina
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Taylors、South Carolina、アメリカ、29687
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Tennessee
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Johnson City、Tennessee、アメリカ、37604
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Texas
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Grand Prairie、Texas、アメリカ、75052
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Wisconsin
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Menomonee Falls、Wisconsin、アメリカ、53051
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Buenos Aires、アルゼンチン、C1188AAF
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Ramos Mejia、アルゼンチン、B1704ETD
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Bangalore、インド、560052
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Chennai、インド、600086
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Cochin、インド、682026
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Mumbai、インド、400 067
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Pune、インド、411011
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Lugo、スペイン、27004
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Palma de Mallorca、スペイン、07014
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Santa Cruz de Tenerife、スペイン、38320
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Valencia、スペイン、46015
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Budapest、ハンガリー、H-1139
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Eger、ハンガリー、3300
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Mako、ハンガリー、6900
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Szekesfehervar、ハンガリー、8000
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Szekszard、ハンガリー、7100
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Veszprem、ハンガリー、8200
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Krakow、ポーランド、30-349
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Poznan、ポーランド、61-495
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Rzeszow、ポーランド、35-068
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Chihuahua、メキシコ、31238
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Guadalajara、メキシコ、44340
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Chiayi City、台湾、600
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Neihu Taipei、台湾、114
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Tainan、台湾、704
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Taipei、台湾、100
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Yung-Kang, Tainan、台湾、710
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Goyang-Si、大韓民国、410-719
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Sungnam-Si、大韓民国、463-712
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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:
- Have type 2 diabetes mellitus for at least 1 year.
- Are at least 18 years old.
- Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following: Metformin--1500 milligrams per day (mg/day); Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-intravenous (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
- Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
- Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).
Exclusion Criteria
- Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
- Have taken any glucose-lowering medications not included in Inclusion Criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
- Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
- Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter [micromol/L]).
- Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.
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 |
|---|---|
|
実験的：Insulin Lispro Protamine Suspension
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
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Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
他の名前：
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アクティブコンパレータ：Detemir
Detemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
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Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
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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 |
時間枠 |
|---|---|
|
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
時間枠：Baseline, 24 Weeks
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Baseline, 24 Weeks
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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 |
|---|---|---|
|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
時間枠：Baseline to 24 Weeks
|
Overall: any time after randomization.
Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL.
Nocturnal: any hypoglycemic event that occurred between bedtime and waking.
Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.
|
Baseline to 24 Weeks
|
|
Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks
時間枠：Baseline, 12 Weeks, 24 Weeks
|
Baseline, 12 Weeks, 24 Weeks
|
|
|
Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint
時間枠：24 Weeks
|
Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7.0% and less than or equal to 6.5% at endpoint.
|
24 Weeks
|
|
Glycemic Variability
時間枠：24 Weeks
|
Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose [SMBG] profiles at endpoint) for the actual morning pre-meal blood glucose value.
|
24 Weeks
|
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7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint
時間枠：24 Weeks
|
Actual daily mean blood glucose levels at endpoint.
|
24 Weeks
|
|
Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods
時間枠：Baseline to 24 Weeks
|
Overall: any time after randomization.
Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL.
Nocturnal: any hypoglycemic event that occurred between bedtime and waking.
Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
Results are for the combined titration and maintenance periods.
|
Baseline to 24 Weeks
|
|
1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
時間枠：Baseline to 24 Weeks
|
Overall: any time after randomization.
Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL.
Nocturnal: any hypoglycemic event that occurred between bedtime and waking.
Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.
|
Baseline to 24 Weeks
|
|
Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint
時間枠：Baseline, 24 Weeks
|
Baseline, 24 Weeks
|
|
|
Total Daily Insulin Dose (Units) at Endpoint
時間枠：24 Weeks
|
Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).
|
24 Weeks
|
|
Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint
時間枠：24 Weeks
|
Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (Units/kilograms).
|
24 Weeks
|
|
Number of Injections of Basal Insulin Analog at Endpoint
時間枠：24 Weeks
|
24 Weeks
|
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
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
- Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.
- Fogelfeld L, Dharmalingam M, Robling K, Jones C, Swanson D, Jacober S. A randomized, treat-to-target trial comparing insulin lispro protamine suspension and insulin detemir in insulin-naive patients with Type 2 diabetes. Diabet Med. 2010 Feb;27(2):181-8. doi: 10.1111/j.1464-5491.2009.02899.x.
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
2007年8月1日
一次修了 (実際)
2008年9月1日
研究の完了 (実際)
2008年9月1日
試験登録日
最初に提出
2007年6月27日
QC基準を満たした最初の提出物
2007年6月27日
最初の投稿 (見積もり)
2007年6月29日
学習記録の更新
投稿された最後の更新 (見積もり)
2009年11月11日
QC基準を満たした最後の更新が送信されました
2009年11月4日
最終確認日
2009年11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。