A Prospective, Multicentric, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog Glargine plus Glulisine with Premixed Insulin in Adult Patients with Type 2 Diabetes Mellitus

India Diabetes Research Foundation0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Insulin naÃ¯ve men and women with T2DM on stable dose of 2 or 3 OHAs for at least 3 months
•2. Both men and women of age more than or equal to 18 and less than or equal to 65 years
•3. Have an HbA1c more than or equal to 7.5% and less than or equal to 10.5% with fasting blood glucose more than or equal to 150 mg/dl and/or Postprandial blood glucose more than or equal to 200 mg/dl
•4. Body mass index less than or equal to 40 kg/m2
•5. Have given written informed consent to participate in this study in accordance with local regulations
•6. Subject must have access to telephone for calling into the clinical center as part of test product compliance

•1. Type 1 diabetes
•2. BMI more than 40 kg/m2
•3. Subject is being treated for severe active infection of any type
•4. Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study
•5. Planned surgery in the next 6 months
•6. Any event forecasted to require a temporary need to switch to insulin

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