CTRI/2019/10/021595尚未招募4 期
Open Label, Randomized, Controlled Study to Evaluate Partial Meal Replacement Program with Prohance D Targeting Glycemic levels and Weight control in type II Diabetic Population - ET1903001
Sun Pharma Industries limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Age : 18 â?? 65 years inclusive, Male and non-pregnant females
- •2. Diagnosis of Type 2 Diabetes Mellitus since at least 1 year, treated with stable dose of oral anti-diabetic drugs (drugs permitted include: metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, GLP1 agonists) for at least month before screening
- •3. Patients with HbA1c from 6.5 to 10 %
- •4. Body mass index (BMI) :- 23 â?? 34 kg/m2 and as per consensus statement for Asian Indians for obesity
- •5. Patient willing to provide informed consent and willing to comply
排除标准
- •1. Type I Diabetes Mellitus & Type 2 Diabetes Mellitus patient on basal or multiple injections
- •2. Allergy to one or more components of the study product or history of food allergies
- •3. Patient receiving any diabetes specific nutritional food supplement that does not include multivitamin supplements (Except Ca/Vit D supplements and B complex syrups) within 15 days prior to study start.
- •4. Patient taking any herbal/Ayurvedic Traditional preparation that could profoundly affect blood glucose
- •5. Females who are nursing / pregnant / are of child - bearing potential and not practicing an acceptable method of birth control / or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
- •6. Patient has evidence or history of clinically significant hematological, renal,endocrine,pulmonary,gastrointestinal,cardiovascular,hepatic,psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- •7. Patient with impaired hepatic function as defined by serum levels of alanine transaminase (SGPT), aspartate transaminase (SGOT), alkaline phosphatase 3Ã? ULN (Upper Limit of Normal), total bilirubin 1.50 x ULN in the past 1 year Patient has a history of jaundice in the past 1 year Patient has a impaired renal function, as defined by serum creatinine - 1.4 for women and 1.5 for men, in the past 1 year.
- •8. Patient has a history of acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection.
- •9. Patient has a history of severe diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation or evidence or history of diabetic complications with significant end organ damage.
- •10. Patient has a history of illicit drug or alcohol abuse within last 1 year.
- •11. Patients on therapy with the following drugs will not be permitted to participate in the trial: glucocorticoids, pentamidine, nicotinic acid, diazoxide, adrenergic agonists, hydantoins, asparaginase, interferon, antipsychotics (atypicals and others), epinephrine, anti-secretory agents, cyclosporine, tacrolimus, digoxin, quinine, salicylates, multivitamins, high-ceiling diuretics, appetite stimulants, progestational agents, growth hormones, other anabolic agents, sibutramine, orlistat, rimonabant and drugs which will affect folate metabolism, currently or within past 3 months from the time of informed consent.
- •12. Patient has a history of any condition possibly affecting absorption of study product.
- •13. Patient has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start.
- •14. has any major or minor surgery within 30 days prior to screening.
- •15. Patient has a history or confirmed diagnosis of malignancy.
研究者
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