Investigation of the effect of E.-coli-Nissle as supporting therapy to antidiabetic standard care in patients with diabetes mellitus type 2

Phase 1

Conditions: Diabetes mellitus type 2
MedDRA version: 17.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2014-000936-40-DE

Lead Sponsor: GWT-TUD GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Diabetes mellitus type 2
- HbA1c >7% (stable for 6 months)
- oral antidiabetic therapie for 6 months with Metformin, Vildagliptin, Gliniden or without Oral antidiabetic medication
- age between 45 and 80 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

-Myocardial infarction or stroke within the last 5 years
- insulin therapy
-Therapy with arcabose
-Acute periphere arterial disease within the last 12 months
-Insable metabolic situation
-Uncontrolled hypertension
-Body-Mass-Index = 35 kg/m²
-Smokers
-Daily consumption of probiotic food
-Malignant disease within the last 5 years
-Status post transplantation
-Immunosuppressive therapy within the last 3 months
-Therapy with antibiotics
-Macroalbuminuria
-Severe liver disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Decrease in HbA1c levels within baseline and end of treatment;Secondary Objective: -change in insulin resistance/secretion<br>- change in lipid parameters<br>- change in parameters of oxidative stress<br>- change in parameters of inflammation<br>- change in gastrointestinal condition<br>- tolerance of therapy;Primary end point(s): Decrease in HbA1c levels within baseline and end of treatment;Timepoint(s) of evaluation of this end point: for patients: 26 weeks (2 weeks screening phase + 24 weeks treatment phase)<br><br>for trial: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -change in insulin resistance/secretion<br>- change in lipid parameters<br>- change in parameters of oxidative stress<br>- change in parameters of inflammation<br>- change in gastrointestinal condition<br>- tolerance of treatment;Timepoint(s) of evaluation of this end point: for patients: 26 weeks (2 weeks screening phase + 24 weeks treatment phase)<br><br>for trial: 12 months