NCT00315718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2006

Completed
Last Updated

April 19, 2006

Status Verified

April 1, 2006

First QC Date

April 18, 2006

Last Update Submit

April 18, 2006

Conditions

Diabetes Mellitus, Type 2

Keywords

Hintonia latiflora extractDiabetes mellitus type 2HbA1cSafetyLiver function tests

Outcome Measures

Primary Outcomes (1)

  • HbA1c values

Secondary Outcomes (8)

  • Postprandial blood glucose

  • Fasting blood glucose

  • General vegetative symptoms

  • BMI

  • Liver function tests (ALT, GGT, AP)

  • +3 more secondary outcomes

Interventions

Extract from Hintonia latiflora barkDRUG

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hepatic impairment
  • Renal impairment
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Trencin

Trenčín, SK-91171, Slovakia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Marta Korecova, Dr. med.

    Head of Diabetes Department, IDF President, Rc: 425201/734, Vel'komoravská 2, SK-91101 Trencin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 19, 2006

Study Start

June 1, 2002

Study Completion

June 1, 2005

Last Updated

April 19, 2006

Record last verified: 2006-04

Locations

SL(1)