Study to Evaluate Safety and Efficacy of PreCrea® on Subjects With Higher Than Normal Blood Sugar Levels

Diabetes Mellitus Clinical Trial

— Precrea  

Official title:

A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, Study to Evaluate the Efficacy and Safety of PreCrea®, a Twice-daily Dietary Supplement in People With Higher Than Normal Blood Sugar Levels.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189005
• Other study ID #: Precre/Nutra001/PMI13
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2014
• Last updated: May 14, 2015
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: PreEmptive Meds, Pvt. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the efficacy and safety of PreCrea® on subjects with higher than normal blood sugar levels.

Description:

A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate the efficacy and safety of PreCrea®, a twice-daily dietary supplement in people with higher than normal blood sugar levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age = 18 years to = 65 years

2. Newly diagnosed Male or Female participants with higher than normal blood sugar levels (FPG >100 mg/dL) on of Pre-Diabetes and Diabetes Mellitus during screening and not on any treatment

3. Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures

Exclusion Criteria:

1. Subjects with Type 1 Diabetes Mellitus

2. Participants on insulin therapy and other oral anti-diabetic agents or having uncontrolled diabetes.

3. Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.

4. Cardiac status New York Heart Association class III-IV

5. Uncontrolled blood pressure > 150 mmhg systolic and > 100 mmhg diastolic

6. Impaired renal function as shown by but not limited to serum creatinine = 1.5 mg/dl for males and = 1.4 mg/dl for female

7. Clinically significant peripheral edema

8. Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN)

9. Participants on steroid

10. Pregnancy or lactating women

11. Known hypersensitivity to any of the study drugs

12. Any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu.

13. Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years

14. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol

15. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study.

16. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Hyperglycemia
• Metabolic Syndrome
• Metabolic Syndrome X
• Pre-Diabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Study dietary supplement (PreCrea 600 mg capsules)
Study dietary supplement (PreCrea 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with life style modification.
• Placebo

Locations

Country	Name	City	State
India	Dia Care- Diabetes Care and Hormone Clinic	Ahmedabad	Gujarat
India	St. Johns College and Hospital	Bangalore	Karnataka
India	Totall Diabetes and Hormone Institution	Indore	Madhya Pradesh
India	Diabetes Care Centre	Jaipur	Rajasthan
India	Bhatia Hospital	Mumbai	Maharashtra
India	Inamdar Multispeciality Hospital	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Joe Fenn

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety of Dietary Supplement PreCrea 600 mg twice-daily with Liver Function	Measure changes in Liver Function Tests: Aspartate Aminotransferase (AST) from baseline (Day 1) to End of Study (Day 90); Alanine Aminotransferase (ALT) from baseline (Day1) to End of Study (Day 90); Alkanine Phosphatase (ALP) from baseline (Day1) to End of Study (Day 90	Baseline (Day 1) to End of Study (Day 90)	Yes
Primary	Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Hemoglobin A1c (Hb A1c) levels	Change in HbA1c % from baseline (Day 1) to end of supplementation/treatment after 90 days	Day 1(Baseline) to Day 90 (End of Study)	No
Primary	Safety of Dietary Supplement PreCrea 600 mg twice-daily	Measure changes in Renal Function Tests: Blood Urea Nitrogen (BUN) from baseline (Day 1) to end of study (Day 90); Serum Creatinine from baseline (Day 1) to end of study (Day 90)	Day 1 (Baseline) to Day 90 (End of Study)	Yes
Secondary	Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Fasting Plasma Glucose (FPG)	Change in FPG % from baseline (Day1) to end of supplementation/treatment after 90 days	Day 1 (Baseline) to Day 90 (End of Study)	No