IRCT201104266297N1已完成4 期
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 Oral Anti Diabetic Drugs alone in Iran
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
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
- 年龄范围
- 18 years 至 no limit（—）
- 性别
- All
入选标准
- •Inclusion Criteria
- •1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- •2. Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1.
- •3. Male or female, age =18 years of age
- •4. HbA1c = 7.0 %- = 11 % at screening
- •5. Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
- •6. An antidiabetic regimen that has been stable for at least 3 months prior to screening
- •7. An antidiabetic regimen that includes a minimum of 2 OADs
- •8. OADs dosed at = 50% of the maximum recommended dose
- •9. Able and willing to adhere to the therapeutic regimen
- •10. Able and willing to perform SMBG testing as per protocol
- •11. Opthalmoscopic examination within 12 months prior to screening
- •Exclusion Criteria
- •1. Known or suspected hypersensitivity to trial product(s) or related products
- •2. 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).
- •3. The receipt of any investigational medicinal product within one month prior to this trial.
- •4. Suffer from a life threatening disease (cancer)
- •5. Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to Screening
- •6. Cardiac disease: class III or IV CHF, unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening
- •7. Hepatic insufficiency (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 2 times the central laboratory's upper reference limit)
- •8. Renal insufficiency (serum creatinine > 1.6 mg/dl for males; 1.4 mg/dl for females
- •9. Recurrent hypoglycaemia or hypoglycaemic unawareness
- •10. Anemia (haemoglobin < 10 mg/dl)
- •11. Use of concomitant medications which may alter glucose metabolism including but not limited to: systemic or inhaled glucocorticoids, anabolic steroids, non-selective beta-blockers
- •12. Known or suspected abuse of alcohol, narcotics or illicit substances
- •13. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write
- •14. Any conditions that the Investigator judges would interfere with trial participation or evaluation of the results
排除标准
- 未提供
研究者
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