CTRI/2013/01/003314 [Registered on: 22/01/2013] Trial Registered Retrospectively
Last Modified On:
18/11/2019
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Nutraceutical
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A clinical study on effects of Sugaheal® in patients with Type 2 Diabetes Mellitus
Scientific Title of Study
A randomized, double-blind, prospective, parallel study to assess efficacy and safety of Sugaheal®, a standardized extract of fenugreek seeds, in treatment naïve patients with type 2 diabetes mellitus
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
SUGAHEAL-DM v.2.1 Dated 10-10-2012
Protocol Number
U1111-1133-9719
UTN
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Type 2 Diabetes Mellitus, (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Placebo
Placebo Tablet (one tablet, Oral, twice a day) for 24 weeks
Intervention
Sugaheal
Sugaheal Tablet (350 mg, one
tablet, Oral, twice a day) for 24 weeks
Intervention
Sugaheal
Sugaheal Tablet (500 mg, one
tablet, Oral, twice a day) for 24 weeks
Inclusion Criteria
Age From
30.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Treatment naïve patients of type 2 diabetes mellitus (defined as never receiving medical treatment for diabetes [insulin and/or oral antihyperglycemic medication] for > 6 months since original diagnosis, and no oral antihyperglycemic medication for more than 3 consecutive days or 7 nonconsecutive days during the 8 weeks prior to screening)
2. Fasting Plasma glucose (FPG) between 126 mg/dl and 250 mg/dl
3. Male or Female between 30 years to 65 years of age
4. Body Mass Index (BMI) between 18 kg/m2 to 30 kg/m2
5. HbA1c between 7% to 10% both inclusive
6. If on anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit.
7. Patients those have voluntarily given written informed consent
8. Women with childbearing potential, willing to use effective contraceptive measures (other than oral contraceptive pills) such mechanical or barrier contraceptives, post- menopausal will be included.
9. In the opinion of the investigator, able to comply with the requirements of the protocol
10. Patients who received counseling on diet and exercise consistent with ADA recommendations
ExclusionCriteria
Details
• Patients on hyperglycemic agent at screening visit
• Type 1 diabetes patients
• Females who are pregnant, lactating or planning to become pregnant
• Known allergy to study medication
• Patients with underline chronic disease of heart, liver, kidney, endocrine or neurological disease.
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma
• Has a contagious, infectious disease
• Currently taking herbals, dietary supplements, or medications, during the past 12 weeks that could profoundly affect blood glucose
• Active malignancy.
• AST / ALT more than or equal to 2.5 times the upper limit of normal laboratory value ( i.e. AST more than or equal to 100 and ALT more than or equal to 25 )
• Serum creatinine more than or equal to1.5 mg/dl,
• Any other conditions not eligible for the trial as per investigator or clinically significant abnormal laboratory values at screening visit.
• Clinically significant abnormal red cell turnover, such as recent blood loss or transfusion or anemia [hemoglobin levels: less than 10 mg% (Male) and less than 9 mg% (Female)]
• Patient of heart disease of Class III (marked limitation of any activity, the patient is comfortable only at rest) and Class IV (any physical activity brings discomfort and symptom occur at rest) as per New York Heart Association functional classification of heart diseases
• Patients who smokes10 cigarettes per day
• Alcohol intake more than 2 drinks/day
• Subject participating simultaneously or 3 months prior to screening in any other clinical trial.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Glycated hemoglobin (HbA1c) values (%)
Screening, Week-12, Week-24
Secondary Outcome
Outcome
TimePoints
Efficacy (measurements): Fasting plasma glucose (FPG) in mg/dl.
Skinfold thickness measurement (mm) – in male (chest, abdomen, thigh) and in female (iliac crest, triceps, thigh)
Randomization, Week-12, Week-24
Quality of Life measurement
Randomization, Week-12, Week-24
HOMA-IR, Insulin sensitivity index, Fat content (%), Matsuda Index, Oral glucose insulin sensitivity (OGIS),BMI, Waist to Hip ratio (WHR)
To be calculated at Week-24 (end of study)
Number and Proportion of subjects achieving
a) HbA1c targets less than or equal to 6.5% (IDF criteria),
b) HbA1c targets less than or equal to 7 % (ADA criteria),
c) 20%, 50% and 70% reduction in FPG
d) requiring Metformin and /or other rescue medication addition
To be calculated at Week-24 (end of study)
Adverse Event (AE) Monitoring – Number and percent of subjects a) experiencing adverse events (AEs), (SAEs) b) discontinuation due to AE and c) with abnormal laboratory parameters (narratives with drug, disease, concomitant
Cumulative and average daily dose of Metformin and/or other rescue medication per patient per arm
To be calculated at Week-24 (end of study)
Safety parameters: Biochemical safety parameters - Liver function (ALT, AST, Total Protein, Albumin, Alkaline phosphate, Total direct indirect), Kidney Function (BUN, and creatinine).
Total Sample Size="276" Sample Size from India="276" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Diabetes mellitus (DM), is a lifestyle disorder of progressive nature. Initial anti-hyperglycemic monotherapy is often unsuccessful at getting patients with type 2 DM to glycemic goals. Therefore, initial combination therapy is recommended in newly diagnosed patients. The present study is proposed to evaluate efficacy and safety of Sugaheal® in treatment naïve patients with type 2 DM. The investigational product, Sugaheal®, standardized extract of fenugreek seeds. Efficacy in animal model of DM and safety is well established Therefore, Sugaheal is expected to improve glycemic control as well as overall management of DM.
A total of 276 patients will be randomized as per blocks (based on gender and HbA1c range) in 1:1:1 ratio to 3 arms of the study i.e. Placebo, Sugaheal-350 and Sugaheal-500 each. Randomized patients will receive assigned treatment twice daily for 24 weeks. Efficacy evaluations will be based on primary and secondary outcomes. The primary outcome measure of the study is Glycated haemoglobin (HbA1c) values. Secondary outcome measures in terms of glucose homeostasis (FPG and PPPG), anthropometric parameters, skinfold thickness measurement, HOMA-IR, and lipid profile, matsuda index, oral glucose insulin sensitivity (OGIS), BMI, Waist to Hip ratio (WHR), fasting Glucose AUC, and QOL assessments. Safety parameters include biochemical liver function parameters (ALT, AST, total protein, albumin, alkaline phosphate, bilirubin (total direct indirect), and kidney function parameters (BUN, and creatinine), and vital signs (heart rate, blood pressure, pulse rate, and ECG). The provision of rescue medication is made. AE and SAE monitoring will also be done as a part of safety evaluations.