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

This study has been completed.
Sponsor:
Information provided by:
Harras Pharma Curarina GmbH
ClinicalTrials.gov Identifier:
NCT00315718
First received: April 18, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted

April 18, 2006
April 18, 2006
June 2002
Not Provided
HbA1c values
Same as current
No Changes Posted
  • 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)
Same as current
Not Provided
Not Provided
 
Long-Term Effects of Sucontral(TM) on Mild and Moderate Cases of Diabetes Mellitus (Type 2)
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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: Extract from Hintonia latiflora bark
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2005
Not Provided

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
Both
45 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Slovakia
 
NCT00315718
HPC-02/1998
Not Provided
Not Provided
Harras Pharma Curarina GmbH
Not Provided
Principal Investigator: Marta Korecova, Dr. med. Head of Diabetes Department, IDF President, Rc: 425201/734, Vel’komoravská 2, SK-91101 Trencin
Harras Pharma Curarina GmbH
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP