NCT01427920已完成4 期
A 20 Week 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- Change in HbA1c (Glycosylated Haemoglobin) - FAS
研究概览
简要总结
This trial was conducted in Asia, Europe and South America. The aim of this trial was to confirm efficacy of subject driven titration (individually adjusted) of biphasic insulin aspart 30 (BIAsp 30) twice daily in terms of glycaemic control assessed by change in glycosylated haemoglobin (HbA1c).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 was allowed. The last sample was to be conclusive)
- •Body Mass Index (BMI) below or equal to 40.0 kg/m^2
- •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 was allowed. The last sample was to be conclusive)
- •Impaired kidney function with serum creatinine above or equal to 133 micromol/L (1.5 mg/dL) for males and above or equal to 124 micromol/L (1.4 mg/dL) for females (one re-test within one week of screening visit was allowed. The last sample was to 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) or bolus insulin. Previous use of pre-mixed or bolus insulin products was allowed only in case of hospitalisation or a severe condition requiring intermittent use of pre-mixed or bolus insulin products for less than 14 consecutive days, but not during the last 3 months prior to screening visit (Visit 1)
研究组 & 干预措施
Subject-driven titration BIAsp 30 (BID) + metformin
Experimental
The subjects performed the titration of BIAsp 30 dose.
干预措施: biphasic insulin aspart 30 (Drug)
Investigator-driven titration BIAsp 30 (BID) + metformin
Active Comparator
The investigator performed the titration of BIAsp 30 dose.
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
Change in HbA1c (Glycosylated Haemoglobin) - FAS
时间窗: Week 0, week 20
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).
Change in HbA1c (Glycosylated Haemoglobin) - PP
时间窗: Week 0, week 20
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in per protocol (PP) analysis set.
次要结局
- Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values)(Week 0, week 20)
- Number of Treatment Emergent Hypoglycaemic Episodes(Week 0 to week 20)
- Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score(Week 20)
研究者
研究点 (1)
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