EUCTR2010-024303-27-PL进行中（未招募）不适用
A 20 weeks randomised, multinational, open labelled, 2 armed, parallel group comparison of twice daily subject-driven titration of biphasic insulin aspart (BIAsp) 30 versus twice daily investigator-driven titration of biphasic insulin aspart (BIAsp) 30 both in combination with metformin in subjects with type 2 diabetes inadequately controlled on basal insulin analogues - SimpleMix™
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
- 338
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
- •- Male or female, age =18
- •- Diagnosed with type 2 diabetes for a minimum of 12 months prior to Visit 1
- •- Currently treated with a basal insulin analogue for at least 3 months prior to Visit 1
- •- Stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg
- •metformin or maximum tolerated dose (minimum 1000 mg) ± additional OAD treatment. The
- •metformin treatment must have been stable for at least 2 months prior to Visit 1
- •- HbA1c = 7.0% and =10.0%. (One re-test within one week of screening visit is allowed. The last
- •sample will be conclusive.)
- •- Body Mass Index (BMI) = 40.0 kg/m2
- •- Able and willing to eat at least 2 main meals each day during the trial
- •- Able and willing to adhere to the protocol including compliance with performance of self
- •measured plasma glucose (SMPG), injection regimen and titrating themselves according to the
- •- Experience in performing self measured plasma glucose (SMPG)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
排除标准
- •- Treatment with any thiazolidinedione (TZD) and Glucagon-like peptide-1 (GLP-1) receptor
- •agonists or pramlintide within the last 3 months prior to Visit 1
- •- Impaired hepatic function defined as alanine aminotransferase (ALAT)= 2.5 times upper
- •referenced limit. (One re-test within one week of screening visit is allowed. The last sample will
- •be conclusive.)
- •- Impaired kidney function with serum creatinine = 133 µmol/L (1.5 mg/dL) for males and = 124
- •µmol/L (1.4 mg/dL) for females. (One re-test within one week of screening visit is allowed. The
- •last sample will be conclusive.)
- •- Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic
- •blood pressure = 180 mmHg and/or diastolic blood pressure = 100 mmHg)
- •- Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human
- •preparations) or bolus insulin. Previous use of pre-mixed or bolus insulin products is allowed only in case of hospitalisation or a severe condition requiring intermittent use of premixed or bolus insulin products for less than 14 consecutive days, but not during the last 3 months prior to screening visit (Visit 1)
研究者
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