CTRI/2019/11/022083已完成4 期
An Open labeled, Non Randomized, Clinical study to Evaluate the Glucose Lowering effect of KAL-10 Meal in patients with type 2 diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
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
入选标准
- •1. Patients in the age group of 18 to 60 years, both inclusive.
- •2. Patients suffering from Type II Diabetes Mellitus for more than one
- •year, and stabilized on mono / poly oral hypoglycemic drug underanti-diabetic therapy.
- •3. Patients having HbA1c value below 8% at screening.
- •4. Patients of female gender or non-pregnant, non-lactating females.
- •A urine pregnancy test is required for all female subjects of
- •childbearing potential unless subject has had a hysterectomy, tubal
- •ligation, or is > 2 years postmenopausal.
- •5. Patients who willing to follow the procedures as per the study
- •protocol and voluntarily sign an informed consent form.
排除标准
- •1. Type-I & Type-II Diabetic patients who are on Insulin.
- •2. Known cases of severe/chronic hepatic or renal disease.
- •3. Known patient of any active malignancy.
- •4. Patients giving history of significant cardiovascular event 5.
- •Patients having history of known major complications of Diabetes like
- •Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic
- •6. Patients having history of known chronic, contagious infectious
- •disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •7. Known patients of having active metabolic or gastrointestinal
- •diseases that may interfere with nutrient absorption, metabolism, or
- •excretion, excluding diabetes.
- •8. Patients using any other investigational drug within 1 month prior
- •to recruitment
- •9. Patients currently participating in any other clinical study
- •10. Any other condition due to which patients are deemed to be
- •unsuitable by the investigator for reason(s) not specifically stated in
- •the exclusion criteria
研究者
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