Back to resultsRole of DbXell in the Treatment of Subjects With Mildly Uncontrolled Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
DbXell
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes, Diabetes Mellitus, Herbal, food supplement
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects with age of 18-70 years Established type 2 diabetes mellitus as defined by the American Diabetes Association, but of duration less than 10 years.
- Suboptimal glycemic control as judged by HbA1c over target but not more than 8.0%.Current medication of not more than 2 oral hypoglycemic agents. No current or past insulin or GLP1 therapy.
- FPG ≤ 180 mg/dL
- Hemoglobin level of ≥ 10.0 g/dL
- Serum ALT ≤ 2.5 times upper limit of normal
- Serum creatinine < 1.5 times upper limit of normal
Exclusion Criteria:
- Female of childbearing potential
- Subjects with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other symptomatic ischemic arterial diseases necessitating medical treatment
- Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg)
- History of renal and/or liver disease
- History of or the presence of any clinical evidence of malignancies
- Presence of exacerbation of chronic illnesses, severe and acute infections, complicated infections
- Current treatment with systemic corticosteroids or herbal (alternative) medicines
- Participation in any other intervention trial within 30 days prior to Screening
Sites / Locations
- Laniado Hospital, Diabetes Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DbXell
Placebo
Arm Description
Drug: DbXell three times daily for 12 weeks and then switching to Placebo of DbXell for 12 additional months Other: Lifestyle modification Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.
Drug: Placebo of DbXell Placebo of DbXell three times daily for 12 weeks and then switching to DbXell for 12 additional weeks Other: Lifestyle modification Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.
Outcomes
Primary Outcome Measures
Change in HbA1C concentrations and fasting glucose levels
Secondary Outcome Measures
Full Information
NCT ID
NCT02123732
First Posted
April 2, 2014
Last Updated
March 5, 2017
Sponsor
Laniado Hospital
Collaborators
KGS Research
1. Study Identification
Unique Protocol Identification Number
NCT02123732
Brief Title
Role of DbXell in the Treatment of Subjects With Mildly Uncontrolled Type 2 Diabetes Mellitus
Official Title
Role of DbXell in the Treatment of Subjects With Mildly Uncontrolled Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laniado Hospital
Collaborators
KGS Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a 2-arm, single-blind, crossover, placebo-controlled clinical study, with 24 weeks of therapy to evaluate the efficacy and safety of DbXell in improving metabolic control in patients with Type 2 Diabetes that is mildly uncontrolled, defined as HbA1c above target but less than 8.0% on their current conventional therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes, Diabetes Mellitus, Herbal, food supplement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DbXell
Arm Type
Experimental
Arm Description
Drug: DbXell three times daily for 12 weeks and then switching to Placebo of DbXell for 12 additional months Other: Lifestyle modification Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo of DbXell Placebo of DbXell three times daily for 12 weeks and then switching to DbXell for 12 additional weeks Other: Lifestyle modification Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.
Intervention Type
Dietary Supplement
Intervention Name(s)
DbXell
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in HbA1C concentrations and fasting glucose levels
Time Frame
6 months from last patient in
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects with age of 18-70 years Established type 2 diabetes mellitus as defined by the American Diabetes Association, but of duration less than 10 years.
Suboptimal glycemic control as judged by HbA1c over target but not more than 8.0%.Current medication of not more than 2 oral hypoglycemic agents. No current or past insulin or GLP1 therapy.
FPG ≤ 180 mg/dL
Hemoglobin level of ≥ 10.0 g/dL
Serum ALT ≤ 2.5 times upper limit of normal
Serum creatinine < 1.5 times upper limit of normal
Exclusion Criteria:
Female of childbearing potential
Subjects with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other symptomatic ischemic arterial diseases necessitating medical treatment
Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg)
History of renal and/or liver disease
History of or the presence of any clinical evidence of malignancies
Presence of exacerbation of chronic illnesses, severe and acute infections, complicated infections
Current treatment with systemic corticosteroids or herbal (alternative) medicines
Participation in any other intervention trial within 30 days prior to Screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Niven, MD
Organizational Affiliation
Laniado Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laniado Hospital, Diabetes Unit
City
Netanya
ZIP/Postal Code
42150
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Role of DbXell in the Treatment of Subjects With Mildly Uncontrolled Type 2 Diabetes Mellitus
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