Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315718
Status:
COMPLETED
Last Update Posted:
2006-04-19
First Post:
2006-04-18
Brief Title:
Long-Term Effects of SucontralTM on Mild and Moderate Cases of Diabetes Mellitus Type 2
Sponsor:
Harras Pharma Curarina GmbH
Organization:
Harras Pharma Curarina GmbH
Study Overview
Official Title:
Controlled Clinical Trial on Long Term Effects of Hintonia Latiflora Extract in Mild to Moderate Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 145 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 mlday 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 239 and 219 18 mmol and 20 mmol in absolute values Mean postprandial glucose was reduced by 244 and 165 24 and 20 mmol in absolute values and the mean HbA1c was decreased by 104 and 124 076 and 104 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
To evaluate the long term effects of an aqueous-ethanolic extract from the bark of Hintonia latiflora 145 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 mlday 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 239 and 219 18 mmol and 20 mmol in absolute values Mean postprandial glucose was reduced by 244 and 165 24 and 20 mmol in absolute values and the mean HbA1c was decreased by 104 and 124 076 and 104 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None