Diabetes Mellitus, Type 2Phase 3NCT00315718
Long-Term Effects of Sucontral(TM) on Mild and Moderate Cases of Diabetes Mellitus (Type 2)
A Phase 3 study testing Extract from Hintonia latiflora bark in people with Diabetes Mellitus, Type 2, run by Harras Pharma Curarina GmbH at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Extract from Hintonia latiflora bark
- How many people
- 10 participants
- Where
- 1 siteSlovakia
- Study dates
- Jun 2002to Jun 2005
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hepatic impairment
- Renal impairment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Clinical Trial on Long Term Effects of Hintonia Latiflora Extract in Mild to Moderate Type 2 Diabetes
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Extract from Hintonia latiflora bark
- Keywords
- Hintonia latiflora extract, Diabetes mellitus type 2, HbA1c, Safety, Liver function tests
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extract from Hintonia latiflora barkDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c values
Secondary outcomes (8)
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study startJun 2002
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Harras Pharma Curarina GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marta Korecova, Dr. med., Principal investigator, Head of Diabetes Department, IDF President, Rc: 425201/734, Vel'komoravská 2, SK-91101 Trencin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315718
- Sponsor's protocol ID
- HPC-02/1998
- Status last verified
- Apr 2006
- First submitted
- 18 Apr 2006
- Last updated
- 19 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Clinical Trial on Long Term Effects of Hintonia Latiflora Extract in Mild to Moderate Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00315718
- Acronym / sponsor ID
- HPC-02/1998
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Hintonia latiflora extract, Diabetes mellitus type 2, HbA1c, Safety, Liver function tests
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- Harras Pharma Curarina GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Study completion
- Jun 2005
- First posted
- 19 Apr 2006 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Hepatic impairment
- Renal impairment
- Pregnancy
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 |
|---|---|---|
| Extract from Hintonia latiflora bark | Drug | – |
Primary outcome
HbA1c values
8 secondary outcomes
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)
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 19 Apr 2006.
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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.
Marta Korecova, Dr. med. principal investigator
Head of Diabetes Department, IDF President, Rc: 425201/734, Vel'komoravská 2, SK-91101 Trencin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Extract from Hintonia latiflora bark in people with Diabetes Mellitus, Type 2, run by Harras Pharma Curarina GmbH at 1 site in Slovakia.
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 5 inclusion and 3 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 19 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. 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. 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?
HbA1c values. 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 19 Apr 2006.