| Trial ID: | L2220 |
| Source ID: | NCT02144948
|
| Associated Drug: |
E.-Coli-Nissle
|
| Title: |
Investigation of the Effect of E.-Coli-Nissle as Supporting Therapy to Standard Care of Diabetes Mellitus Type II
|
| Acronym: |
PUNiDIA
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type II
|
| Interventions: |
DRUG: e.-coli-nissle
|
| Outcome Measures: |
Primary: Decrease in HbA1c levels, 24 weeks | Secondary: change in insulin resistance/secretion, 24 weeks|change in lipid parameters, 24 weeks|change in parameters of oxidative stress, 24 weeks|change in gastrointestinal condition, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: GWT-TUD GmbH | Collaborators: Ardeypharm GmbH
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
10
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-08
|
| Completion Date: |
2016-01
|
| Results First Posted: |
|
| Last Update Posted: |
2017-02-14
|
| Locations: |
Carus-Hausarztpraxis, Dresden, 01307, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02144948
|
