Clinical trial NCT00315718: Long-Term Effects of Sucontral(TM) on Mild and Moderate Cases of Diabetes Mellitus (Type 2)
Official title: Controlled Clinical Trial on Long Term Effects of Hintonia Latiflora Extract in Mild to Moderate Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Hintonia latiflora extract
Diabetes mellitus type 2
HbA1c
Safety
Liver function tests
Lead sponsor: Harras Pharma Curarina GmbH
Sponsor class: INDUSTRY
First posted: 2006-04-19
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: HbA1c values
Secondary outcomes:
measure: Postprandial blood glucose
measure: Fasting blood glucose
measure: General vegetative symptoms
measure: BMI
measure: Liver function tests (ALT, GGT, AP)
measure: Serum lipids (triglycerides, cholesterol, HDL cholesterol)
measure: Adverse drug reactions (narratives)
measure: Blood pressure (systolic/diastolic)
Other outcomes:
Locations:
city: Trencin
country: Slovakia
facility: Hospital of Trencin
Study officials:
affiliation: Head of Diabetes Department, IDF President, Rc: 425201/734, Vel'komoravská 2, SK-91101 Trencin
name: Marta Korecova, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: