Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Test group: Intervention/Test Arm (Group A): Prohance-D (Diabetes Specific Nutritional Supplement) + Standard of Care (Diabetes treatment along with Life Style modification and Diet as
Sponsors
Madras Diabetes Research Foundation
Sun Pharmaceutical Industries Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Age: 30- 65 years old male and non-pregnant females Diagnosis of Type 2 Diabetes Mellitus for at least 1 year; treated with stable dose of oral anti-diabetic drugs (drugs permitted: metformin, sulfonylureas, Thiazolidinediones, DPP-IV inhibitors, AGIs) for at least 3 months before screening. Participants with HbA1c from 8 to 11% Body mass index (BMI) =25 kg/m2 Participant willing to provide informed consent and willing to comply with study procedures
Exclusion criteria
Exclusion criteria: Type 1 Diabetes Mellitus participants. Type 2 Diabetes Mellitus participants on insulin, GLP-1 agonists and/or SGLT2 inhibitors. Allergy to one or more components of the investigational product or history of food allergies Participant receiving any diabetes specific nutritional food supplement apart from multivitamin/ mineral supplements (Ca/Vit D supplements and B complex syrups) within 15 days prior to study start. Participant taking any herbal/ ayurvedic/ alternative medicine preparations 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. Participant has evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, which in the opinion of the investigator, can adversely affect study outcome/s. Participant with active infection in past 30 days. Participant with history of acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection. Participant has a history of any episode(s) of severe hypoglycemia (requiring third party assistance), disabling diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation or evidence or history of diabetic complications with significant end organ damage. Participant has a history of illicit drug or alcohol abuse within last 1 year. Participants on therapy with the following drugs will not be permitted to participate in the trial: DRUGS CAUSING HYPERGLYCEMIA (Thiazides, Glucocorticoids, Diazoxide, Glucagon, Phenytoin, Tacrolimus, Niacin, L-asparaginase, Cyclosporine, Protease inhibitors) and DRUGS CAUSING HYPOGLYCEMIA (Quinine, Insulin, Ethanol, Octreotide, Salicylates-late in overdose), currently or within past 3 months from the time of screening Participants on any pharmacological therapy of modern or alternative medicine for management of obesity in past 6 months. Participants with history of bariatric surgery. Participant has any major or minor surgery within 30 days prior to screening. Participant has a history or confirmed diagnosis of malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in incremental Area Under the Curve (iAUC) on Ambulatory Glucose Profile using Continuous Glucose monitoring from baseline to 12 weeksTimepoint: 2 time points baseline and end of 12 weeks study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in CGM variables such as Mean amplitude of Glycemic excursions (MAGE),Time in Range (TIR),Time above range (TAR),Time below range (TBR),Mean blood glucoseTimepoint: 2 time points baseline and end of 12 weeks study period.;Mean change in HbA1C levelsTimepoint: 2 time points baseline and end of 12 weeks study period.;Mean changes in fasting blood glucose levelsTimepoint: 4 time points baseline,4,8 and end of 12 weeks study period.;Mean changes in post prandial blood glucose levelsTimepoint: 2 time points baseline and end of 12 weeks study period.;Mean changes in anthropometric measurement (weight, BMI & waist circumference)Timepoint: Anthropometric measurements will also be measured monthly once Assessed using 24 hr dietary recall 3 times at baseline and twice a month during the intervention period;Mean changes in lipid profile [total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides]Timepoint: 2 time points baseline and end of 12 weeks study period.;Mean change in plasma fatty acids level in a sub sample of 60 participants (30 in each arm)Timepoint: 2 time points baseline and end of 12 weeks study period.;Change in participant-reported outcomes on satiety using satiety rating scaleTimepoint: 4 time points baseline,4,8 and end of 12 weeks study period.;Proportion of participants with adverse events and serious adverse eventsTimepoint: 7 time points start from day 1 and every week of the study | — |
Countries
India
Contacts
Public ContactMrs Sudha Vasudevan
Madras Diabetes Research Foundation
Outcome results
None listed