Long-Term Effects of Sucontral(TM) on Mild and Moderate Cases of Diabetes Mellitus (Type 2)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
Slovakia
Study Type
Interventional
Intervention
Extract from Hintonia latiflora bark
Sponsored by

About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Hintonia latiflora extract, Diabetes mellitus type 2, HbA1c, Safety, Liver function tests
Eligibility Criteria
Inclusion Criteria: Mild to moderate Diabetes mellitus type 2 stable adjusted to diet Minimum duration of diabetic complaints 1 year Fasting serum glucose 7-14 mmol/l HbA1c max. 12% Written consent Exclusion Criteria: Hepatic impairment Renal impairment Pregnancy
Sites / Locations
- Hospital of Trencin
Outcomes
Primary Outcome Measures
HbA1c values
Secondary Outcome Measures
Postprandial blood glucose
Fasting blood glucose
General vegetative symptoms
BMI
Liver function tests (ALT, GGT, AP)
Serum lipids (triglycerides, cholesterol, HDL cholesterol)
Adverse drug reactions (narratives)
Blood pressure (systolic/diastolic)
Full Information
NCT ID
NCT00315718
First Posted
April 18, 2006
Last Updated
April 18, 2006
Sponsor
Harras Pharma Curarina GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00315718
Brief Title
Long-Term Effects of Sucontral(TM) on Mild and Moderate Cases of Diabetes Mellitus (Type 2)
Official Title
Controlled Clinical Trial on Long Term Effects of Hintonia Latiflora Extract in Mild to Moderate Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Harras Pharma Curarina GmbH
4. Oversight
5. Study Description
Brief Summary
In patients with diabetes mellitus type 2 stably adjusted to diet long-term intake of aqueous-ethanolic extract from Hintonia latiflora over more than 12 months leads to a statstically significant amelioration of parameters of glycaemic control (HbA1c, postprandial and fasting glucose) not acchievable with diet alone.
As safety parameters, liver function tests and cardiovascular parameters are to be monitored. Adverse events are to be monitored.
Detailed Description
Objective:
To evaluate the long term effects of an aqueous-ethanolic extract from the bark of Hintonia latiflora (1:4.5, extraction medium 32% ethanol) in mild to moderate cases of type II diabetes, especially on parameters of glycaemic control and safety.
Research Design and Methods:
The trial was carried out as a controlled single-centre open study. 30 patients stably adjusted to diet were treated with the study medication (3 x 2 ml/day before meals) for up to 36 months. Efficacy parameters were HbA1c and fasting and postprandial serum glucose. As parameters for safety, liver function tests, cardiac functions and adverse events were assessed.
Results:
All three efficacy parameters improved significantly, and the parameters of glycaemic control remained stable for the study duration of 36 months. As compared to baseline, after 6 months and 18 months of therapy mean fasting glucose was reduced by 23.9 and 21.9 % (1.8 mmol and 2.0 mmol in absolute values). Mean postprandial glucose was reduced by 24.4 and 16.5 % (2.4 and 2.0 mmol in absolute values), and the mean HbA1c was decreased by 10.4 and 12.4 % (0.76 and 1.04% in absolute figures). Improvement was maintained after 18 months. Tolerability was excellent. No hypoglycaemic reactions occurred. No adverse effects or change in cardiac and liver function tests were observed. There was a tendency towards decreasing triglyceride and total cholesterol levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Hintonia latiflora extract, Diabetes mellitus type 2, HbA1c, Safety, Liver function tests
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Extract from Hintonia latiflora bark
Primary Outcome Measure Information:
Title
HbA1c values
Secondary Outcome Measure Information:
Title
Postprandial blood glucose
Title
Fasting blood glucose
Title
General vegetative symptoms
Title
BMI
Title
Liver function tests (ALT, GGT, AP)
Title
Serum lipids (triglycerides, cholesterol, HDL cholesterol)
Title
Adverse drug reactions (narratives)
Title
Blood pressure (systolic/diastolic)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild to moderate Diabetes mellitus type 2 stable adjusted to diet
Minimum duration of diabetic complaints 1 year
Fasting serum glucose 7-14 mmol/l
HbA1c max. 12%
Written consent
Exclusion Criteria:
Hepatic impairment
Renal impairment
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Korecova, Dr. med.
Organizational Affiliation
Head of Diabetes Department, IDF President, Rc: 425201/734, Vel'komoravská 2, SK-91101 Trencin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Trencin
City
Trencin
ZIP/Postal Code
SK-91171
Country
Slovakia
12. IPD Sharing Statement
Learn more about this trial
Long-Term Effects of Sucontral(TM) on Mild and Moderate Cases of Diabetes Mellitus (Type 2)
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