NCT01215435已完成4 期
An Open Labelled, Randomised, Parallel Trial; Efficacy and Safety Comparison of Two Different Biphasic Insulin Aspart 30 Treatment Initiation Regimens Followed by Intensification in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs Alone in Iran
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
- 245
- 主要终点
- Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to compare the glycaemic control when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic drugs) alone.
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 6 months prior to Visit 1
- •HbA1c at least 7.0 % - maximum 11 % at screening
- •Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
- •An antidiabetic regimen that has been stable for at least 3 months prior to screening
- •An antidiabetic regimen that includes a minimum of 2 OADs
- •OADs dosed at least 50% of the maximum recommended dose
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
- •The receipt of any investigational medicinal product within one month prior to this trial
- •Suffer from a life threatening disease (cancer)
- •Cardiac disease: class III or IV congestive heart failure (CHF), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening
- •Hepatic insufficiency (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 2 times the central laboratory's upper reference limit)
- •Renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females
- •Recurrent hypoglycaemia or hypoglycaemic unawareness
- •Anemia (haemoglobin below 10 mg/dl)
研究组 & 干预措施
Pre-breakfast BIAsp 30
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
Pre-dinner BIAsp 30
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11
时间窗: Week 0, Week 11
Estimated mean change from baseline in HbA1c after 11 weeks of treatment
次要结局
- Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36(Week 0, Week 36)
- Number of Treatment Emergent Hypoglycaemic Episodes(Week 0 to Week 36)
研究者
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