Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide
2011年1月12日 更新者：Eli Lilly and Company
A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide
This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.
調査の概要
研究の種類
介入
入学 (実際)
339
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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Arizona
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Phoenix、Arizona、アメリカ、85028
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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California
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Concord、California、アメリカ、94520
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Escondido、California、アメリカ、92026
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Fresno、California、アメリカ、93720
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Modesto、California、アメリカ、95355
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Orange、California、アメリカ、92869
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Florida
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Inverness、Florida、アメリカ、34452
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Jacksonville、Florida、アメリカ、32204
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Lake Worth、Florida、アメリカ、33461
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Miami、Florida、アメリカ、33183
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Orlando、Florida、アメリカ、32804
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Palm Harbor、Florida、アメリカ、34684
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Pembroke Pines、Florida、アメリカ、33029
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Plantation、Florida、アメリカ、33324
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West Palm Beach、Florida、アメリカ、33401
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Hawaii
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Honolulu、Hawaii、アメリカ、96813
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Idaho
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Idaho Falls、Idaho、アメリカ、83404
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Indiana
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Avon、Indiana、アメリカ、46123
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Bloomington、Indiana、アメリカ、47403
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South Bend、Indiana、アメリカ、46617
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Iowa
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Des Moines、Iowa、アメリカ、50314
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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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Baton Rouge、Louisiana、アメリカ、70808
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Lafayette、Louisiana、アメリカ、70503
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Metairie、Louisiana、アメリカ、70006
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Maine
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Biddeford、Maine、アメリカ、04005
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Missouri
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Chesterfield、Missouri、アメリカ、63017
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Jefferson City、Missouri、アメリカ、65109
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St Louis、Missouri、アメリカ、63104
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Nebraska
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Omaha、Nebraska、アメリカ、68131
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Nevada
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Las Vegas、Nevada、アメリカ、89148
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New Hampshire
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Nashua、New Hampshire、アメリカ、03063
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New York
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Rochester、New York、アメリカ、14607
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Syracuse、New York、アメリカ、13210
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North Carolina
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Morehead City、North Carolina、アメリカ、28557
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Ohio
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London、Ohio、アメリカ、43140
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Mason、Ohio、アメリカ、45040
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Toledo、Ohio、アメリカ、43606
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South Carolina
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Greer、South Carolina、アメリカ、29651
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Myrtle Beach、South Carolina、アメリカ、29572
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Tennessee
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Kingsport、Tennessee、アメリカ、37660
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Memphis、Tennessee、アメリカ、38119
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Texas
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Austin、Texas、アメリカ、78731
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Dallas、Texas、アメリカ、75231
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San Antonio、Texas、アメリカ、78229
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Vermont
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South Burlington、Vermont、アメリカ、05403
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Virginia
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Virginia Beach、Virginia、アメリカ、23462
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Washington
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Spokane、Washington、アメリカ、99202
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Vancouver、Washington、アメリカ、98664
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Ponce、プエルトリコ、00731
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Toa Baja、プエルトリコ、00949
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Yabucoa、プエルトリコ、00767
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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～74年 (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:
- Must have type 2 diabetes
- Must be at least 18 years of age and less than 75 years of age
- Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
- Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
- Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%
Exclusion Criteria:
- Must not have used insulin on a regular basis during the past 2 years
- Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
- Must not have had more than one episode of severe hypoglycemia in the past 6 months
- Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
- Must not be pregnant or intend to get pregnant during the course of the study
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：ILPS
Insulin Lispro Protamine Suspension (ILPS)
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Administered subcutaneously once a day at bedtime
他の名前：
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アクティブコンパレータ：Glargine
Insulin Glargine
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Administered subcutaneously once a day at bedtime
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 |
|---|---|---|
|
Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
時間枠：Baseline, Endpoint (LOCF) up to 24 weeks
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Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.
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Baseline, Endpoint (LOCF) up to 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 |
|---|---|---|
|
Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
時間枠：24 weeks, Endpoint (LOCF) up to 24 weeks
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Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
|
24 weeks, Endpoint (LOCF) up to 24 weeks
|
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Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
時間枠：Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
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Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
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Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
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Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
時間枠：Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
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Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
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7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
時間枠：Baseline, Endpoint (LOCF) up to 24 weeks
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SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours.
Post-prandial glucose is measured 2 hours after the start of the meal.
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
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Glycemic Variability at Baseline and Endpoint (LOCF)
時間枠：Baseline, Endpoint (LOCF) up to 24 weeks
|
Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose.
Mean SD was calculated based on the SD for each participant in the study.
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
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Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
時間枠：Baseline to Endpoint (LOCF) up to 24 weeks
|
Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL.
Non-nocturnal:any episode that occurred between waking and bedtime.
Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100.
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Baseline to Endpoint (LOCF) up to 24 weeks
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Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
時間枠：Baseline to Endpoint (LOCF) up to 24 weeks
|
Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall.
Rate is reported as episodes/participant/365 days.
Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment.
Overall=any time during the post-randomization visits within the study period.
Nocturnal=Any episode that occurs between bedtime and waking.
Non-Nocturnal=Any episode that occurs between waking and bedtime.
|
Baseline to Endpoint (LOCF) up to 24 weeks
|
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Actual Body Weight at Baseline and Endpoint (LOCF)
時間枠：Baseline, Endpoint (LOCF) up to 24 weeks
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
|
|
Change From Baseline in Body Weight at Endpoint (LOCF)
時間枠：Baseline, Endpoint (LOCF) up to 24 weeks
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
|
|
Total Daily Insulin Dose at Endpoint (LOCF)
時間枠：Endpoint (LOCF) up to 24 weeks
|
Endpoint (LOCF) up to 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
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11月1日
一次修了 (実際)
2009年12月1日
研究の完了 (実際)
2009年12月1日
試験登録日
最初に提出
2007年11月15日
QC基準を満たした最初の提出物
2007年11月15日
最初の投稿 (見積もり)
2007年11月19日
学習記録の更新
投稿された最後の更新 (見積もり)
2011年1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1月12日
最終確認日
2011年1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。