CTRI/2011/12/002241已完成4 期
A 20 week randomised, multinational, open labelled, 2 armed, parallel group comparison of twice daily subjectdriven 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 - BIASP-3878 SimpleMixâ?¢
ovo Nordisk India Private Limited0 个研究点目标入组 91 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Diagnosed with type 2 diabetes for a minimum of 12 months prior to Visit 1 (screening)
- •Currently treated with a basal insulin analogue for at least 3 months prior to Visit 1 (screening)
- •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 (screening)
- •HbA1c higher or equal to 7.0% and below or equal to 10.0% (one re-test within one week of screening visit is allowed. The last sample will be conclusive)
- •Body Mass Index (BMI) below or equal to 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 protocol
- •Experience in performing self measured plasma glucose (SMPG)
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 (screening)
- •Impaired hepatic function defined as alanine aminotransferase (ALAT) above or equal to 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 above or equal to 133 µmol/L (1.5 mg/dL) for males and above or equal to 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 higher or equal to 180 mmHg and/or diastolic blood pressure higher or equal to 100 mmHg)
- •Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations)
研究者
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