رادار التجارب AI | ||
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حالة التجربة السريرية NCT01076842 لـ السكري من النوع 2 هي مكتمل. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
دراسة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث
نوفو نورديسكEfficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment المرحلة الرابعة ٧٥
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات الدراسة باللغة التي اخترتها.
التجربة السريرية NCT01076842 كانت مصممة لدراسة علاج لـالسكري من النوع 2. كانت دراسة تدخُّلية من المرحلة الرابعة وهي الآن مكتمل. بدأت في ٢٤ ربيع الأول ١٤٢٩ هـ مع خطة لتجنيد ٧٥ مشاركًا. بقيادة نوفو نورديسك، وكان من المتوقع اكتمالها في ٢٧ ربيع الآخر ١٤٣٢ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢٥ رجب ١٤٣٢ هـ.
الملخص
The purpose of this study is to compare the effectiveness of two different kinds of diabetes medications, insulin detemir (Levemir) and exenatide (Byetta), in improving blood sugar levels with little or no weight gain in patients with type 2 diabetes who are not well controlled on two or more oral (by mouth) diabetes medications. Both medications are given by injection with a very small needle just below the surface ...عرض المزيد
وصف مفصل
Finding a safe and effective method of improving blood glucose (BG) control without weight gain is one of the major goals of diabetes research. Previous research studies have shown that Levemir and Byetta are safe and effective medications in the treatment of type 2 diabetes. Both drugs have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of type 2 diabetes. The use of Levemir and Byett...عرض المزيد
العنوان الرسمي
The Effect of Detemir Compared to Exenatide and/or the Combination of Detemir and Exenatide on Glycemic Control and Weight in Patients With Type 2 Diabetes Mellitus Who Have Failed Oral Hypoglycemic Agents
الحالات الطبية
السكري من النوع 2معرّفات دراسة أخرى
- 08-13028
NCT معرّف
تاريخ البدء (فعلي)
2008-04
آخر تحديث مُنشور
2011-06-27
تاريخ الاكتمال (المقدر)
2011-04
عدد المشاركين المخطط لهم
٧٥
نوع الدراسة
تدخُّلية
المرحلة
المرحلة الرابعة
الحالة
مكتمل
الكلمات الرئيسية
Diabetes
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
مقارن نشطA Levemir Levemir once daily, force titrated to reach a fasting plasma glucose of 100 mg/dl | Insulin-Levemir Levemir once daily, force titrated to reach a fasting plasma glucose of 100 mg/dl SenseWear Pro3® armband For one-week prior to beginning the assigned medication and for one week , week 11 and week 23, the patients will wear the SenseWear Pro3® armband for collection of ancillary physiologic data DexCom CGM For one-week prior to beginning the assigned medication and for one week , week 11 and week 23, the patients will wear the DexCom CGM for collection of continuous blood glucose concentrations. |
مقارن نشطB Exenatide Exenatide twice daily, started at a dose of 5 mcg b.i.d. and increased to 10 mcg b.i.d. after 2 weeks if the fasting plasma glucose of 100 mg/dl is not reached. Exenatide will be administered immediately before breakfast and dinner meals. No further increase in the dose of exenatide will take place. For those who are unable to tolerate exenatide at a 10 mcg b.i.d. dose, it will be reduced to 5 mcg b.i.d. and continue...عرض المزيد | Exenatide-Bayetta Exenatide twice daily, started at a dose of 5 mcg b.i.d. and increased to 10 mcg b.i.d. after 2 weeks if the fasting plasma glucose of 100 mg/dl is not reached. Exenatide will be administered immediately before breakfast and dinner meals. No further increase in the dose of exenatide will take place. For those who are unable to tolerate exenatide at a 10 mcg b.i.d. dose, it will be reduced to 5 mcg b.i.d. and continue...عرض المزيد SenseWear Pro3® armband For one-week prior to beginning the assigned medication and for one week , week 11 and week 23, the patients will wear the SenseWear Pro3® armband for collection of ancillary physiologic data DexCom CGM For one-week prior to beginning the assigned medication and for one week , week 11 and week 23, the patients will wear the DexCom CGM for collection of continuous blood glucose concentrations. |
مقارن نشطC Levemir+Exenatide Patients from either Group A or Group B who have not reached the goal A1C of 6.5% will be assigned to this Group. They will receive the drug assigned to the other group in addition to the one they were originally assigned. | Insulin-Levemir and Exenatide-Bayetta Patients from either Group A or Group B who have not reached the goal A1C of 6.5% will be assigned to this Group. They will receive the drug assigned to the other group in addition to the one they were originally assigned. SenseWear Pro3® armband For one-week prior to beginning the assigned medication and for one week , week 11 and week 23, the patients will wear the SenseWear Pro3® armband for collection of ancillary physiologic data DexCom CGM For one-week prior to beginning the assigned medication and for one week , week 11 and week 23, the patients will wear the DexCom CGM for collection of continuous blood glucose concentrations. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
The primary endpoint is the improvement in A1C goal measured in mean reduction in A1c levels over 24 weeks. | 1 month |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Hypoglycemia weight waist-hip ratio frequency of hypoglycemia weight FBGL lipid levels CBC CMP biometric parameters of activity heat flux galvanic skin response heart rate level of physical activity and energy expenditure | 1 month |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- A diagnosis of Type 2 DM for over six months
- A history of inadequate glycemic control (A1c > 7.5% but < 10%) despite treatment with 2 or more oral hypoglycemic agents
- 18 years of age or older
- Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous 6 months)
- Naïve to insulin (no insulin for more than 14 days during the previous 6 months and none within 60 days of beginning the study)
- On at least ½ maximum or the greatest tolerable dose of their oral agents according to the label for at least 3 months
- BMI < 40 kg/m2
- Willing to perform at least four finger stick blood glucose measurements each day
- A diagnosis of Type 2 DM for less than six months
- An A1c of < 7.5% or > 10%
- Pregnancy as determined by a serum ß HCG.
- An unstable medical status
- Taking glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study
- Inability to read and write English
- Someone who is not likely to return for the follow-up because they or their sponsor is likely to have a permanent change of station or termination of service before completion of the protocol
- Unwilling to perform four finger stick blood glucose measurements each day
- Previous history of use of exenatide
نوفو نورديسك131 دراسات نشطة للاستكشافBodyMediaلا توجد بيانات اتصال.
2 مواقع الدراسة في 1 بلدان
District of Columbia
MedStar Research Institute, Washington D.C., District of Columbia, 20003, United States
Walter Reed Army Medical Center, Washington D.C., District of Columbia, 20306, United States