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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315718
• Other study ID #: HPC-02/1998
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2006
• Last updated: April 18, 2006
• Start date: June 2002
• Est. completion date: June 2005

Study information

• Verified date: April 2006
• Source: Harras Pharma Curarina GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovak Republic: State Institute for Drug Control (SUKL)Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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.

As safety parameters, liver function tests and cardiovascular parameters are to be monitored. Adverse events are to be monitored.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Extract from Hintonia latiflora bark

Locations

Country	Name	City	State
Slovakia	Hospital of Trencin	Trencin

Sponsors (1)

Lead Sponsor	Collaborator
Harras Pharma Curarina GmbH

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c values
Secondary	Postprandial blood glucose
Secondary	Fasting blood glucose
Secondary	General vegetative symptoms
Secondary	BMI
Secondary	Liver function tests (ALT, GGT, AP)
Secondary	Serum lipids (triglycerides, cholesterol, HDL cholesterol)
Secondary	Adverse drug reactions (narratives)
Secondary	Blood pressure (systolic/diastolic)