- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01275027
A Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin
A Phase II, Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin
Study Overview
Detailed Description
The investigational product has helped decrease the amount of insulin needed in treating diabetic dogs and has improved the dogs' longevity and quality of life. Observational analysis by trained veterinarians has indicated that the natural fluctuations in blood glucose levels do not exist in dogs consuming the product. An initial Phase 1 study tested the product in a brownie form. The product has been reformulated to capsule form for the Phase 2 study.
The hypothesis for this study is that diabetic individuals will decrease their insulin/diabetic medication usage and have a decrease in glucose levels after consuming the product for 16 weeks.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Avera Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women who are at least 18 years old
- Diagnosis of Type 2 Diabetes
- Has been on stable diabetes medication/insulin for the past three months
Exclusion Criteria:
- Women who are pregnant, breastfeeding or planning to become pregnant
- Diagnosis of Celiac Disease or gluten intolerance
- Current or active kidney disease
- Current or active liver disease
- Any food allergies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nutralin
Individuals with Type 2 Diabetes
|
7 capsules taken 15 minutes before each of the three main meals of the day
|
Placebo Comparator: Placebo
Individuals with Type 2 Diabetes
|
7 capsules taken 15 minutes before each of the three main meals of the day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Sugar
Time Frame: 16 weeks
|
blood sugar levels
|
16 weeks
|
HgA1c reduction
Time Frame: 16 weeks
|
reduction of Hemoglobin A1c levels
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diabetes medication
Time Frame: 16 weeks
|
reduction in the amount of diabetes medication needed
|
16 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Edward Zawada, MD, Avera McKennan Hospital & University Health Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ARI-1340-Nutralin
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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