Diabetes MellitusPhase 3PrecreaNCT02189005
Study to Evaluate Safety and Efficacy of PreCrea® on Subjects With Higher Than Normal Blood Sugar Levels
A Phase 3 study testing Study dietary supplement (PreCrea 600 mg capsules) in people with Diabetes Mellitus and Pre-Diabetes, run by Joe Fenn at 6 sites in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Pre-Diabetes, Hyperglycemia
- What is being tested?
- Study dietary supplement (PreCrea 600 mg capsules)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 6 sitesIndia
- Study dates
- Nov 2013to Nov 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
- Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
Dia Care- Diabetes Care and Hormone Clinic
Ahmedabad, Gujarat, 380015
St. Johns College and Hospital
Bangalore, Karnataka, 560034
Totall Diabetes and Hormone Institution
Indore, Madhya Pradesh, 452010
Diabetes Care Centre
Jaipur, Rajasthan, 302018
Bhatia Hospital
Mumbai, Maharashtra, 411007
Inamdar Multispeciality Hospital
Pune, Maharashtra, 411040
About this study
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.
The purpose of the study is to evaluate the efficacy and safety of PreCrea® on subjects with higher than normal blood sugar levels.
Read the 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.
- Conditions
- Diabetes Mellitus, Pre-Diabetes, Hyperglycemia, Metabolic Syndrome
- Being tested
- Study dietary supplement (PreCrea 600 mg capsules), Placebo
- Keywords
- High blood sugar, High HbA1C, hyperglycemia, Pre-Diabetes, Natural Supplement for Diabetes
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance, Hyperglycemia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study dietary supplement (PreCrea 600 mg capsules)Dietary supplement
Also called PreCrea, Natural Sugar Lowerig Supplement, Predisease
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.
PlaceboDietary supplement
Also called Placebo 600mg capsules
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Change in FPG % from baseline (Day1) to end of supplementation/treatment after 90 days
Measured: Day 1 (Baseline) to Day 90 (End of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joe Fenn
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Joe Fenn, PreEmptive Meds, Pvt. Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189005
- Sponsor's protocol ID
- Precre/Nutra001/PMI13
- Acronym
- Precrea
- Status last verified
- May 2015
- First submitted
- 11 Jul 2014
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02189005
- Acronym / sponsor ID
- Precrea / Precre/Nutra001/PMI13
- Conditions
- Diabetes Mellitus, Pre-Diabetes, Hyperglycemia, Metabolic Syndrome
- Keywords
- High blood sugar, High HbA1C, hyperglycemia, Pre-Diabetes, Natural Supplement for Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Joe FennIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PreCrea | Experimental | 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 program. |
| Placebo 600 mg capsules | Placebo comparator | Dietary Supplement: PlaceboPlacebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study dietary supplement (PreCrea 600 mg capsules)Also: PreCrea, Natural Sugar Lowerig Supplement, PrediseaseStudy 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. | Dietary supplement | PreCrea |
| PlaceboAlso: Placebo 600mg capsules | Dietary supplement | Placebo 600 mg capsules |
Primary outcome
Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Hemoglobin A1c (Hb A1c) levels
Time frame: Day 1(Baseline) to Day 90 (End of Study)
Change in HbA1c % from baseline (Day 1) to end of supplementation/treatment after 90 days
Safety of Dietary Supplement PreCrea 600 mg twice-daily
Time frame: Day 1 (Baseline) to Day 90 (End of Study)
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)
1 secondary outcome
Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Fasting Plasma Glucose (FPG)
Time frame: Day 1 (Baseline) to Day 90 (End of Study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Study dietary supplement (PreCrea 600 mg capsules) in people with Diabetes Mellitus and Pre-Diabetes, run by Joe Fenn at 6 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Hemoglobin A1c (Hb A1c) levels (time frame: Day 1(Baseline) to Day 90 (End of Study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2015.