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

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ClinicalTrials.gov Identifier: NCT00315718
Recruitment Status : Completed
First Posted : April 19, 2006
Last Update Posted : April 19, 2006
Information provided by:
Harras Pharma Curarina GmbH

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Extract from Hintonia latiflora bark Phase 3

Detailed Description:


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.


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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2002
Estimated Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. HbA1c values

Secondary Outcome Measures :
  1. Postprandial blood glucose
  2. Fasting blood glucose
  3. General vegetative symptoms
  4. BMI
  5. Liver function tests (ALT, GGT, AP)
  6. Serum lipids (triglycerides, cholesterol, HDL cholesterol)
  7. Adverse drug reactions (narratives)
  8. Blood pressure (systolic/diastolic)

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315718

Hospital of Trencin
Trencin, Slovakia, SK-91171
Sponsors and Collaborators
Harras Pharma Curarina GmbH
Principal Investigator: Marta Korecova, Dr. med. Head of Diabetes Department, IDF President, Rc: 425201/734, Vel’komoravská 2, SK-91101 Trencin

ClinicalTrials.gov Identifier: NCT00315718     History of Changes
Other Study ID Numbers: HPC-02/1998
First Posted: April 19, 2006    Key Record Dates
Last Update Posted: April 19, 2006
Last Verified: April 2006

Keywords provided by Harras Pharma Curarina GmbH:
Hintonia latiflora extract
Diabetes mellitus type 2
Liver function tests

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases