Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus
2016年10月21日 更新者:AstraZeneca
A Randomized Trial Comparing Exenatide With Placebo in Subjects With Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications
This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.
調査の概要
研究の種類
介入
入学 (実際)
261
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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Peoria、Arizona、アメリカ
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Phoenix、Arizona、アメリカ
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California
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Buena Park、California、アメリカ
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Concord、California、アメリカ
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Fresno、California、アメリカ
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Greenbrae、California、アメリカ
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La Mesa、California、アメリカ
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Lancaster、California、アメリカ
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Northridge、California、アメリカ
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Palm Springs、California、アメリカ
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Salinas、California、アメリカ
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Florida
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Hollywood、Florida、アメリカ
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Jacksonville、Florida、アメリカ
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Georgia
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Atlanta、Georgia、アメリカ
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Hawaii
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Honolulu、Hawaii、アメリカ
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Idaho
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Idaho Falls、Idaho、アメリカ
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Iowa
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Des Moines、Iowa、アメリカ
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Kansas
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Wichita、Kansas、アメリカ
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Louisiana
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Baton Rouge、Louisiana、アメリカ
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Lafayette、Louisiana、アメリカ
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Matairie、Louisiana、アメリカ
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Massachusetts
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Boston、Massachusetts、アメリカ
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Minnesota
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Minneapolis、Minnesota、アメリカ
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Missouri
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Chesterfield、Missouri、アメリカ
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St Louis、Missouri、アメリカ
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Nebraska
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Omaha、Nebraska、アメリカ
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Nevada
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Las Vegas、Nevada、アメリカ
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New Jersey
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Berkeley Heights、New Jersey、アメリカ
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Teaneck、New Jersey、アメリカ
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New Mexico
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Alburquerque、New Mexico、アメリカ
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New York
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New York、New York、アメリカ
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North Carolina
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Durham、North Carolina、アメリカ
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Oregon
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Bend、Oregon、アメリカ
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Texas
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Dallas、Texas、アメリカ
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El Paso、Texas、アメリカ
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Georgetown、Texas、アメリカ
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San Antonio、Texas、アメリカ
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Virginia
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Richmond、Virginia、アメリカ
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Washington
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Vancouver、Washington、アメリカ
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Wisconsin
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Kenosha、Wisconsin、アメリカ
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Birmingham、イギリス
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Guildford、イギリス
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Leicester、イギリス
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Livingston、イギリス
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Middlesbrough、イギリス
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Swansea、イギリス
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Torquay、イギリス
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Holon、イスラエル
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Kfar Sava、イスラエル
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Tel Hashomer、イスラエル
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Athens、ギリシャ
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Thessaloniki、ギリシャ
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Carolina、プエルトリコ
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Hato Rey、プエルトリコ
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Ponce、プエルトリコ
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San Juan、プエルトリコ
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Coatzacoalcos、メキシコ
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Mexico、メキシコ
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Monterrey、メキシコ
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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.
- Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study.
Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:
- metformin (stable dose for 6 weeks)
- pioglitazone (stable dose for 6 weeks)
a combination of metformin and pioglitazone (stable dose for 6 weeks)
- Have HbA1C between 7.1% and 10.5%, inclusive.
- Have a body mass index (BMI) ≤45 kg/m2.
- Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
Exclusion Criteria:
- Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study.
- Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study.
- Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control.
- Women who are breastfeeding.
- Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer.
- Have had a kidney transplant or are currently on kidney dialysis.
- Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years.
- Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients.
- Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study.
- Are currently on a weight-loss program or have been on one within 3 months of entering the study.
- Have had a blood transfusion or severe blood loss within 3 months of entering the study.
- Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study.
- Have an irregular sleep cycle (for example, sleeping during the day and working during the night).
- Have a history of pancreatitis.
- Have received treatment with an experimental drug within 30 days of entering the study.
- If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.
- If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study.
- If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.
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:ダブル
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 in Glycosylated Hemoglobin (HbA1c)
時間枠:baseline and 30 weeks
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Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline).
Unit of measure is percent of hemoglobin that is glycosylated.
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baseline and 30 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 |
---|---|---|
Percentage of Patients Achieving HbA1c <=7%
時間枠:baseline and 30 weeks
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Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).
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baseline and 30 weeks
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Percentage of Patients Achieving HbA1c <=6.5%
時間枠:baseline and 30 weeks
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Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%).
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baseline and 30 weeks
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Change in Fasting Serum Glucose
時間枠:baseline and 30 weeks
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Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)
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baseline and 30 weeks
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Change in 7-point Self-monitored Blood Glucose (SMBG) Profile
時間枠:baseline and 30 weeks
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Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)
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baseline and 30 weeks
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Change in Total Cholesterol
時間枠:baseline and 30 weeks
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Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)
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baseline and 30 weeks
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Change in Low Density Lipoprotein (LDL) Cholesterol
時間枠:baseline and 30 weeks
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Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)
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baseline and 30 weeks
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Change in High Density Lipoprotein (HDL) Cholesterol
時間枠:baseline and 30 weeks
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Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)
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baseline and 30 weeks
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Change in Triglycerides
時間枠:baseline and 30 weeks
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Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)
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baseline and 30 weeks
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Change in Body Weight
時間枠:baseline and 30 weeks
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Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)
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baseline and 30 weeks
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Change in Waist Circumference
時間枠:baseline and 30 weeks
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Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)
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baseline and 30 weeks
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Change in Daily Insulin Dose
時間枠:baseline and 30 weeks
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Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)
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baseline and 30 weeks
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Change in Daily Insulin Dose (on a Per Body Weight Basis)
時間枠:baseline and 30 weeks
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Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)
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baseline and 30 weeks
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Change in Systolic Blood Pressure (SBP)
時間枠:baseline and 30 weeks
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Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)
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baseline and 30 weeks
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Change in Diastolic Blood Pressure (DBP)
時間枠:baseline and 30 weeks
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Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)
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baseline and 30 weeks
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Minor Hypoglycemia Rate Per Year
時間枠:baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
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Number of minor hypoglycemia events experienced per subject per year.
Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).
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baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
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Percentage of Subjects Experiencing Minor Hypoglycemia
時間枠:baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
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Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study.
Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).
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baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
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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
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
- Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
- Buse JB, Han J, Miller S, MacConell L, Pencek R, Wintle M. Addition of exenatide BID to insulin glargine: a post-hoc analysis of the effect on glycemia and weight across a range of insulin titration. Curr Med Res Opin. 2014 Jul;30(7):1209-18. doi: 10.1185/03007995.2014.896329. Epub 2014 Mar 18.
- Zinman B, Philis-Tsimikas A, Cariou B, Handelsman Y, Rodbard HW, Johansen T, Endahl L, Mathieu C; NN1250-3579 (BEGIN Once Long) Trial Investigators. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care. 2012 Dec;35(12):2464-71. doi: 10.2337/dc12-1205. Epub 2012 Oct 5.
- Rosenstock J, Shenouda SK, Bergenstal RM, Buse JB, Glass LC, Heilmann CR, Kwan AY, MacConell LA, Hoogwerf BJ. Baseline factors associated with glycemic control and weight loss when exenatide twice daily is added to optimized insulin glargine in patients with type 2 diabetes. Diabetes Care. 2012 May;35(5):955-8. doi: 10.2337/dc11-1434. Epub 2012 Mar 19.
- Buse JB, Bergenstal RM, Glass LC, Heilmann CR, Lewis MS, Kwan AY, Hoogwerf BJ, Rosenstock J. Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2011 Jan 18;154(2):103-12. doi: 10.7326/0003-4819-154-2-201101180-00300. Epub 2010 Dec 6.
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10月1日
一次修了 (実際)
2010年1月1日
研究の完了 (実際)
2010年1月1日
試験登録日
最初に提出
2008年10月1日
QC基準を満たした最初の提出物
2008年10月1日
最初の投稿 (見積もり)
2008年10月3日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年10月24日
QC基準を満たした最後の更新が送信されました
2016年10月21日
最終確認日
2016年10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。
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