Long-Term Effects of Sucontral(TM) on Mild and Moderate Cases of Diabetes Mellitus (Type 2)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Extract from Hintonia latiflora bark |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Controlled Clinical Trial on Long Term Effects of Hintonia Latiflora Extract in Mild to Moderate Type 2 Diabetes |
- HbA1c values
- 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)
| Estimated Enrollment: | 10 |
| Study Start Date: | June 2002 |
| Estimated Study Completion Date: | June 2005 |
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.
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Slovakia | |
| Hospital of Trencin | |
| Trencin, Slovakia, SK-91171 | |
| Principal Investigator: | Marta Korecova, Dr. med. | Head of Diabetes Department, IDF President, Rc: 425201/734, Vel’komoravská 2, SK-91101 Trencin |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00315718 History of Changes |
| Other Study ID Numbers: | HPC-02/1998 |
| Study First Received: | April 18, 2006 |
| Last Updated: | April 18, 2006 |
| Health Authority: | Slovak Republic: State Institute for Drug Control (SUKL) Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Harras Pharma Curarina GmbH:
|
Hintonia latiflora extract Diabetes mellitus type 2 HbA1c Safety Liver function tests |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013