EUCTR2009-009157-24-ES进行中（未招募）不适用
Estudio multicéntrico, randomizado, doble ciego, con doble enmascaramiento, controlado frente a un comparador activo para evaluar la eficacia, seguridad y tolerancia de taspoglutida (RO5073031) comparado con pioglitazona en pacientes con diabetes mellitus tipo 2 controlados inadecuadamente con sulfonilurea (SU) en monoterapia o con la combinación metformina más sulfonilurea. A multicenter, randomized, double blind (double dummy), active-comparator controlled study to compare the efficacy, safety and tolerability of taspoglutide versus pioglitazone in type 2 diabetes patients inadequately controlled with sulfonylurea (SU) monotherapy or metformin plus sulfonylurea combination therapy. - EMERGE 6
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 648
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. Men and women aged 18 - 75 years at screening. Women of childbearing potential using an approved birth control method (e.g. hormonal contraceptives, IUD, barrier contraception) must be willing to use the same methods of
- •contraception during the entire course of the study.
- •2. Type 2 diabetes patients treated with stable sulfonylurea monotherapy or metformin plus sulfonylurea combination therapy for at least 12 weeks prior to Screening. Sulfonylurea (SU) needs to be at least half-maximally efficacious dose.
- •Metformin dose should be ?1500 mg/day (or individual maximally tolerated dose), but no more than the maximum dose specified in the label.
- •3. Agreement to reduce the SU dosage at randomization (baseline) to the lowest available dose.
- •4. HbA1c: ? 7.0% and ? 10% at Screening.
- •5. Body mass index (BMI) > 25 (> 23 for Asians) and ? 45 kg/m2 at Screening.
- •6. Stable weight ± 5% for at least 12 weeks prior to Screening.
- •7. Agreement to maintain prior diet and exercise habits throughout the entire study.
- •8. Ability and willingness to give written informed consent and to comply with the requirements of the study.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Women who are pregnant, intending to become pregnant during the study period or currently lactating
- •2. Diagnosis of or history of:
- •? Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g. acromegaly and Cushing?s syndrome;
- •? Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months.
- •3. Evidence of clinically significant diabetic complications, e.g. known proliferative retinopathy
- •4. Clinically symptomatic gastrointestinal (GI) disease including but not limited to inflammatory bowel disease, celiac disease, diabetic gastroparesis, and cholelithiasis
- •5. History of bariatric surgery (e.g. gastric bypass or antrectomy) or small or large bowel resection
- •6. History of chronic pancreatitis or idiopathic acute pancreatitis
- •7. Record of more than 3 episodes of severe hypoglycemia (defined as requiring assistance by another person) within 6 months before Screening
- •8. Any abnormality in clinical laboratory tests or ECG, which precludes safe involvement in the study as judged by the Investigator
- •9. Clinically relevant QTc prolongation (e.g. QTc > 480 ms), family history of Long QT Syndrome, or concomitant use of Class I Antiarrythmic drugs (e.g. disopyramide, quinidine, procainamide, mexiletine, flecainide, propafenone)
- •10. Diagnosed and/or treated malignancy (except basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
- •11. Known hemoglobinopathy or chronic anemia
- •12. Donation of one unit (500 ml) or more blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks
- •13. Any concurrent medical condition/disorder that, in the opinion of the Investigator is likely to:
- •? Interfere with the patient?s ability to complete the entire study period or to participate in all aspects of the trial (including and not restricted to the ability to perform the SMBG)
- •? Require, during the study, the administration of a treatment that would affect the interpretation of the efficacy and safety data
- •14. Contraindications and warnings according to the country specific label information for sulfonylurea, metformin (if administered as background therapy) and pioglitazone, not listed in the other exclusion criteria
- •15. Known hypersensitivity to sulfonylurea, metformin (if administered as background therapy) or pioglitazone or any of their components
- •16. Treatment with any oral anti-diabetic medication (other than metformin and sulfonylurea), and/or herbal/over-the-counter preparations that may affect glycemic control within 12 weeks prior to Screening
- •17. Treatment with exenatide or exendin analogues, or GLP-1 analogues at anytime during the past
- •18. Chronic oral or parenteral corticosteroid treatment (>7 consecutive days of treatment) within 4 weeks prior to Screening
- •19. Treatment with weight lowering agents (e.g. orlistat, sibutramine, phentermine) within 12 weeks prior to Screening
- •20. Documented values of blood pressure above SBP > 170 mmHg and/or DBP > 105 mmHg within 12 weeks prior to Screening
- •21. Treatment with anti-hypertensive medications which are not on a stable dose for at least 4 weeks prior to Baseline
- •22. Treatment with lipid lowering medications which are not on a stable dose for at least 8 weeks prior to Screening
- •23. Treatment with thyroid hormones which are not on a stable dose for at least 12 weeks prior to Screening
- •24. Use of
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