Long-Term Effects of Sucontral(TM) on Mild and Moderate Cases of Diabetes Mellitus (Type 2)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Controlled Clinical Trial on Long Term Effects of Hintonia Latiflora Extract in Mild to Moderate Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Extract from Hintonia latiflora bark


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Extract from Hintonia latiflora bark|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c values |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hintonia latiflora extract, Diabetes mellitus type 2, HbA1c, Safety, Liver function tests