Clinical trial NCT02189005: Study to Evaluate Safety and Efficacy of PreCrea® on Subjects With Higher Than Normal Blood Sugar Levels
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Pre-Diabetes
Hyperglycemia
Metabolic Syndrome
Keywords: High blood sugar
High HbA1C
hyperglycemia
Pre-Diabetes
Natural Supplement for Diabetes
Lead sponsor: PreEmptive Meds, Pvt. Ltd
Sponsor class: INDUSTRY
First posted: 2014-07-14
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Hemoglobin A1c (Hb A1c) levels
timeFrame: Day 1(Baseline) to Day 90 (End of Study)
measure: Safety of Dietary Supplement PreCrea 600 mg twice-daily
timeFrame: Day 1 (Baseline) to Day 90 (End of Study)
Secondary outcomes:
measure: Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Fasting Plasma Glucose (FPG)
timeFrame: Day 1 (Baseline) to Day 90 (End of Study)
Other outcomes:
measure: Safety of Dietary Supplement PreCrea 600 mg twice-daily with Liver Function
timeFrame: Baseline (Day 1) to End of Study (Day 90)
Locations:
city: Ahmedabad
country: India
facility: Dia Care- Diabetes Care and Hormone Clinic
state: Gujarat
city: Bangalore
country: India
facility: St. Johns College and Hospital
state: Karnataka
city: Indore
country: India
facility: Totall Diabetes and Hormone Institution
state: Madhya Pradesh
city: Mumbai
country: India
facility: Bhatia Hospital
state: Maharashtra
city: Pune
country: India
facility: Inamdar Multispeciality Hospital
state: Maharashtra
city: Jaipur
country: India
facility: Diabetes Care Centre
state: Rajasthan
Study officials:
References: