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
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Glycemic Control after using Prohance-D
研究概览
简要总结
This study is design to evaluate the safety and efficacy f Partial meal replacement program with Prohance D (Nutraceutical Product) targeting Glycemic levels and weight control in type II Diabetic patients. Thisis an open label, randomized, multi-center, controlled, post marketing study in 200 Indian patients. The study will include at least 3 evaluation points: Baseline/EnrollmentVisit and patient assessments at 06 weeks and 12 weeksafter randomization. Eligible patients meeting inclusion/exclusion criteriawill be enrolled in selected sites to evaluate effect on Weight and GlycemicControl. Testarm (n=100) will receive Prohance-D Vanilla Flavor as supplemental meal.Control arm (n=100)will not receive any meal replacement. Studywill collect data at baseline, week 06 and week 12. There are no study-prescribedprocedures for this study. Because of the “real world†setting of the study,any procedure ordered by the physician during this study will be one that isappropriate to the routine care delivered to the subject at the discretion ofthe participating physician.
Subjects will be under directmedical care during the entire study period. The time points of interest fordata collection are baseline at introduction of Study product, Week 06 and week12 (End of study)Efficacy Variables will be measures as Glycemic Control and weight control after using Prohance D, Change in Lipid profile, Change in Waist Circumference, Change in Fasting and post Prandial Glucose and assess quality of life parameters from baseline of the study at each time point. Safety analysis include Monitoring of AE including hypoglycemia throughout the study period.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age : 18 – 65 years inclusive, Male and non-pregnant females
- •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
- •Patients with HbA1c from 6.5 to 10 %
- •Body mass index (BMI) :- 23 – 34 kg/m2 and as per consensus statement for Asian Indians for obesity
- •Patient willing to provide informed consent and willing to comply.
排除标准
- •Type I Diabetes Mellitus & Type 2 Diabetes Mellitus patient on basal or multiple injections
- •Allergy to one or more components of the study product or history of food allergies
- •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.
- •Patient taking any herbal/Ayurvedic Traditional preparation that could profoundly affect blood glucose
- •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.
- •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)
- •Patient with impaired hepatic function as defined by serum levels of alanine transaminase (SGPT), aspartate transaminase (SGOT), alkaline phosphatase 3× 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.
- •Patient has a history of acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection.
- •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.
- •Patient has a history of illicit drug or alcohol abuse within last 1 year.
- •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.
- •Patient has a history of any condition possibly affecting absorption of study product.
- •Patient has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start.
- •has any major or minor surgery within 30 days prior to screening.
- •Patient has a history or confirmed diagnosis of malignancy.
结局指标
主要结局
Glycemic Control after using Prohance-D
时间窗: Baseline to Week 12
次要结局
- Change in Post Prandial Glucose(Baseline to week 06 and 12 week)
- Change in Weight(Baseline to week 06 and 12 week)
- Change in Lipid Profile(Baseline to week 06 and 12 week)
- Change in Waist Circumference(Baseline to week 06 and 12 week)
- Change in Fasting Glucose(Baseline to week 06 and 12 week)
- Assess quality of life parameters (e.g. Adherence, Compliance, Sateity measurement, Energy fulfillment, taste)(Baseline to week 06 and 12 week)
- Safety monitoring by AE assessment including hypoglycemia(Throughout the study period)