- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00563004
The Effect of DBcare, a Food Supplement on Diabetes Control
A Double-blind Placebo Controlled Study Studying the Efficacy of DBCARE in Improving Diabetes Control
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study design: prospective, randomized, single-blind, placebo-controlled trial
Inclusion criteria:
Men and women (older than 18 years old) with type 2 diabetes and inadequate glycemic control, defined by HbA1C 8% ³ £10%.
Previous medications include any oral hypoglycemic agents, as monotherapy or in combination.
Concurrent lipid-lowering, anti-hypertensive and other medications are allowed
Exclusion criteria (before the study):
Type 1 diabetes mellitus Pregnant or lactating women Insulin treatment 3 months prior to study entry Creatinine >2 mg/dL Abnormal liver function tests GOT>X2 or GPT>X2 the upper normal limit Unstable anginal syndrome Congestive heart failure (NYHA class I-IV) Inability to follow study instructions including low compliance
Exclusion criteria (during the study):
Severe hypoglycemia (less than 50 mg%) or any hypoglycemic event requiring intravenous glucose infusion
Number of patients: 30 patients (drug) 30 patients (placebo)
Design:
Four out-patient visits, at enrollment and every month thereafter At enrollment (visit 1) physical examination will be performed and a full set of blood tests will be withdrawn At 1 week (visit 2) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken At 6 weeks (visit 3) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken At 12 weeks (visit 4), the end of the study, physical examination will be performed and a full set of blood tests will be withdrawn On the 2nd 3rd and 4th visits pill-count will be performed Glucose monitoring: patients will be asked to monitor fasting glucose levels at home, in the morning, on a daily basis
Drugs: identical drug containing/ placebo capsules Drugs for a month will be given in each monthly visit
Dose: 2 tablets three times daily
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kfar-saba, Israel, 44281
- Meir Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults >18y
- With type 2 diabetes mellitus and inadequate glycemic control
- HBA1C >8 <10
- Previous medications include oral hypoglycemic medications,as monotherapy or in combination
Exclusion Criteria:
- Type 1 diabetes mellitus
- Pregnant or lactating women
- Insulin treatment 3 months prior to study entry
- Creatinine >2
- Abnormal liver function test GOT>2 or GPT>2 the upper limit of norm
- Unstable anginal syndrome
- Congestive heart failure NYHA 1-4
- Inability to follow study instructions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
Patients receive the herbal medication DBCARE for 3 months
|
Patients receive dbcare 2 tablets TID for 3 months
PLACEBO PILLS 2 TABLETS TID FOR 3 MONTHS
|
Placebo Comparator: B
PATIENTS RECEIVE PLACEBO PILLS
|
Patients receive dbcare 2 tablets TID for 3 months
PLACEBO PILLS 2 TABLETS TID FOR 3 MONTHS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of more than 0.5% GBA1C in the treatment group compared to placebo
Time Frame: 3 months
|
3 months
|
Reduction in fasting plasma glucose of more than 20% in the treatment group compared to placebo
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction by half in the daily dose of oral hypoglycemic agents compared to baseline
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pnina ROTMAN-PIKELNY, MD, Meir Medical Center
Publications and helpful links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- DBcare1
- DBCARE01
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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