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
  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

Resource links provided by NLM:


Further study details as provided by Harras Pharma Curarina GmbH:

Primary Outcome Measures:
  • HbA1c values

Secondary Outcome Measures:
  • 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
Detailed 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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315718

Locations
Slovakia
Hospital of Trencin
Trencin, Slovakia, SK-91171
Sponsors and Collaborators
Harras Pharma Curarina GmbH
Investigators
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 September 18, 2014