EUCTR2016-003738-25-DE进行中（未招募）1 期
A 28-week, multi-center randomized, double-blind, placebo-controlled study to evaluate the potential of Dapagliflozin plus Exenatide in combination with high-dose intensive insulin therapy compared to Placebo in obese insulin-resistant patients with Type 2 Diabetes mellitus (Proof-of-concept study)
niversity Medical Center Hamburg-Eppendorf0 个研究点目标入组 60 人开始时间: 2017年10月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Informed Consent can be obtained prior to any study procedures.
- •2. Patient is able to read, understand and sign the Informed Consent.
- •3. HbA1c = 8.0% and = 11.0% based on laboratory results
- •4. Currently treated with a stable TDID = 80 U at least 3 months prior to enrolment
- •5. Patients who are receiving metformin must be on a stable total daily dose = 1500 mg or the maximum tolerated dose of metformin within 3 months prior to enrolment
- •6. BMI of = 30 kg/m2 at enrolment
- •7. Male or female and =18 and =75 years old at time of informed consent
- •8. For female patients:
- •- Not breastfeeding.
- •- Negative pregnancy test result (human chorionic gonadotropin, beta subunit
- •[ßhCG]) at Visit 0 (Screening) and Visit 1 (randomization) -not applicable to hysterectomized and post-menopausal females.
- •- If of childbearing potential (including perimenopausal women who have had a
- •menstrual period within 1 year), must practice and be willing to continue to
- •practice appropriate birth control (defined as a method which results in a low
- •failure rate, ie, less than 1% per year, when used consistently and correctly,
- •such as implants, injectables, hormonal contraceptives [pills, vaginal rings, or
- •patches], some intrauterine contraceptive devices [levonorgestrel-releasing or
- •copper-T], tubal ligation or occlusion, or a vasectomized partner) during the
- •entire duration of the study. As applicable, all methods must be in effect prior
- •to receiving the first dose of study medication.
- •- Must practice appropriate birth control as stated above for 10 weeks after the
- •last dose of study medication.
- •9. Patients who are receiving the following medications must be on a stable treatment
- •regimen for a minimum of 2 months prior to Visit 0 (Screening):
- •- Antihypertensive agents
- •- Thyroid replacement therapy
- •- Antidepressant agents
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Diagnosis of Type 1 Diabetes
- •2. History of diabetic ketoacidosis, hyperosmolar coma or corticosteroid-induced Type 2 diabetes
- •3. Patients with significant thyroid disease
- •4. Patients with history of acute or chronic pancreatitis
- •5. Clinically significant cardiovascular disease or procedure within 3 months prior to enrolment or expected to require coronary revascularization procedure
- •6. Presence of history of severe congestive heart failure (NYHA III and IV)
- •7. Creatinin-Clearance of < 60 ml/min based on local laboratory results
- •8. Concomitant medication with loop diuretics
- •9. Pregnant women
- •10. Administration of any other antidiabetic therapy, other than insulin (see inclusion criterion no.4 and 5) and metformin with a stable total daily dose = 1500 mg or the maximum tolerated dose of metformin within 3 months prior to enrolment
- •11. History of, or currently have, acute or chronic pancreatitis, or have triglyceride
- •concentrations = 700 mg/dL (= 7.98 mmol/L) at Visit 0 (Screening).
- •12. History or presence of inflammatory bowel disease or other severe GI diseases,
- •particularly those which may impact gastric emptying, such as gastroparesis or
- •pyloric stenosis.
- •13. History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded.
- •14. Significant hepatic disease, including, but not limited to, acute hepatitis, chronic active hepatitis, or severe hepatic insufficiency, including patients with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or total bilirubin (TB) >2 mg/dL (>34.2 µmol/L) (patients with TB >2 mg/dL [>34.2 µmol/L] and documented Gilbert’s syndrome will be allowed to participate).
- •15. Known history of hepatotoxicity with any medication
- •16. Known history of severe hepatobiliary disease.
- •17. Positive serological test for hepatitis B or hepatitis C.
- •18. Known or suspected human immunodeficiency virus (HIV) infection.
- •19. History of organ transplantation.
- •20. Presence or history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN 2) OR a family history of medullary thyroid carcinoma or MEN 2.
- •21. Malignancy (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 0 (Screening).
- •22. Hemoglobinopathy, hemolytic anemia, or chronic anemia (haemoglobin concentration <11.5 g/dL [115 g/L] for males, <10.5 g/dL [105 g/L] for females) or any other condition known to interfere with the HbA1c methodology.
- •23. Has donated blood or had a significant blood loss within 2 months of first dose of study medication or is planning to donate blood during the study.
- •24. Has donated plasma within 7 days prior to first dose of study medication.
- •25. Any exposure to Exenatide (including BYETTA®, BYDUREON™, or exenatide suspension).
- •26. Any exposure to Dapagliflozin or any SGLT-2 inhibitor.
- •27. Has been treated, is currently being treated, or is expected to require or undergo
- •treatment with any of the following treatment excluded medications:
- •- Any DPP-4 inhibitor within 3 months prior to Visit 0 (Screening).
- •- Any GLP-1 analog within 1 year prior to Visit 0 (Screening).
- •- Systemic corticosteroids within 3 months prior to Visit 0 (Screening) by oral, intravenous, intra-articular, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption. For exampl
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