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

NCT02189005 | Completed Phase 3 DMC

• 1 other identifier: Precre/Nutra001/PMI13
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 6

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.

Conditions

Diabetes Mellitus; Pre-Diabetes; Hyperglycemia; Metabolic Syndrome

Keywords

High blood sugar; High HbA1C; hyperglycemia; Pre-Diabetes; Natural Supplement for Diabetes

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (1)

• Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Fasting Plasma Glucose (FPG)

  Day 1 (Baseline) to Day 90 (End of Study)

Other Outcomes (1)

• Safety of Dietary Supplement PreCrea 600 mg twice-daily with Liver Function

  Baseline (Day 1) to End of Study (Day 90)

Study Arms (2)

PreCrea

EXPERIMENTAL

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 program.

Dietary Supplement: Study dietary supplement (PreCrea 600 mg capsules)

Placebo 600 mg capsules

PLACEBO COMPARATOR

Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.

Dietary Supplement: Placebo

Interventions

Study dietary supplement (PreCrea 600 mg capsules) DIETARY_SUPPLEMENT

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.

Also known as: PreCrea, Natural Sugar Lowerig Supplement, Predisease

PreCrea

Placebo DIETARY_SUPPLEMENT

Also known as: Placebo 600mg capsules

Placebo 600 mg capsules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years to ≤ 65 years
• 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
• 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

You may not qualify if:

• Subjects with Type 1 Diabetes Mellitus
• Participants on insulin therapy and other oral anti-diabetic agents or having uncontrolled diabetes.
• Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
• Cardiac status New York Heart Association class III-IV
• Uncontrolled blood pressure \> 150 mmhg systolic and \> 100 mmhg diastolic
• 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
• Clinically significant peripheral edema
• 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)
• Participants on steroid
• Pregnancy or lactating women
• Known hypersensitivity to any of the study drugs
• 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.
• Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years
• 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
• 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.

Sponsors & Collaborators

• Joe Fenn: lead

Study Sites (6)

Dia Care- Diabetes Care and Hormone Clinic

Ahmedabad, Gujarat, 380015, India

Location

St. Johns College and Hospital

Bangalore, Karnataka, 560034, India

Location

Totall Diabetes and Hormone Institution

Indore, Madhya Pradesh, 452010, India

Location

Bhatia Hospital

Mumbai, Maharashtra, 411007, India

Location

Inamdar Multispeciality Hospital

Pune, Maharashtra, 411040, India

Location

Diabetes Care Centre

Jaipur, Rajasthan, 302018, India

Location

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance; Hyperglycemia; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Medical Director

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 14, 2014
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 18, 2015

Record last verified: 2015-05

Locations

IN (6)