Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Prohance D Vanilla Flavour (Nutraveutical Product): once a day for 12 week
Control Intervention1: Placebo: No treatment
Sponsors
Sun Pharma Industries limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic Control after using Prohance-DTimepoint: Baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess quality of life parameters (e.g. Adherence, Compliance, Sateity measurement, Energy fulfillment, taste)Timepoint: Baseline to week 06 and 12 week;Change in Fasting GlucoseTimepoint: Baseline to week 06 and 12 week;Change in Lipid ProfileTimepoint: Baseline to week 06 and 12 week;Change in Post Prandial GlucoseTimepoint: Baseline to week 06 and 12 week;Change in Waist CircumferenceTimepoint: Baseline to week 06 and 12 week;Change in WeightTimepoint: Baseline to week 06 and 12 week;Safety monitoring by AE assessment including hypoglycemiaTimepoint: Throughout the study period | — |
Countries
India
Contacts
Public ContactDr Nayan Patel
Medical Monitor
Outcome results
None listed