NCT01589653已完成4 期
A 20-week Study Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients Uncontrolled on NPH Insulin
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
- 155
- 试验地点
- 1
- 主要终点
- Change in HbA1c From Baseline
研究概览
简要总结
This trial is conducted in Africa and Asia. The aim of the trial is to compare patient-adjusted versus physician-adjusted titration of BIAsp 30 combined with metformin in type 2 diabetes patients uncontrolled on NPH insulin.
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 screening
- •Currently treated with a NPH insulin for at least 3 months prior to 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 screening
- •HbA1c between 7.0% and 10.0% (both inclusive). (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/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 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 above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
- •Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations)
- •Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
- •Known proliferative retinopathy or maculopathy requiring treatment
研究组 & 干预措施
Subject-driven titration
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
Investigator-driven titration
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
Change in HbA1c From Baseline
时间窗: Week 0, week 20
Change in HbA1c (%) from baseline to the end of the treatment period.
次要结局
- Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline(Week 0, week 20)
- Number of Hypoglycaemic Episodes During the Trial From Baseline(Week 20)
- Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)(Week 0, week 20)
- Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden(Week 0, week 20)
研究者
研究点 (1)
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