Diabetes Mellitus Type IIPhase 3PUNiDIANCT02144948
Investigation of the Effect of E.-Coli-Nissle as Supporting Therapy to Standard Care of Diabetes Mellitus Type II
A Phase 3 study testing e.-coli-nissle in people with Diabetes Mellitus Type II, run by GWT-TUD GmbH at 1 site in Germany.
Trial summary
This is a pilot study to investigate the effect of e.-coli-nissle as supporting therapy to antidiabetic standard care in patients with diabetes mellitus type II Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Diabetes Mellitus Type II
- What is being tested?
- e.-coli-nissle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to Jan 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetes mellitus type 2;
- HbA1c >7 % (stable für 6 months, max. variation of 0,5%)
- stable oral antidiabetic therapy for 6 months with Metformin, Vildagliptin, Gliniden or without oral Antidiabetics
- age of 45 to <80 years (men and women)
Who cannot join
- Myocardial infarction or stroke within the last 5 years
- Therapy with acarbose
- Acute peripheral arterial disease within the last 12 months
- Instable metabolic situation
- Uncontrolled hypertension
- Body-Mass-Index ≥ 35 kg/m²
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Investigate the Effect of E-coli-nissle as Probiotic Adjuvant to Antidiabetic Standard Care in Patients With Diabetes Mellitus Type II
This is a pilot study to investigate the effect of e.-coli-nissle as supporting therapy to antidiabetic standard care in patients with diabetes mellitus type II
- Conditions
- Diabetes Mellitus Type II
- Being tested
- e.-coli-nissle
- Keywords
- diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e.-coli-nissleDrug
Also called Mutaflor
1 ml qd for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| E.-coli-Nissle | Experimental | 10 patients will be enrolled Intervention: E.-coli-Nissle (Mutaflor), oral suspension Dose: 1 ml / day frequency: qd Receives: Drug: e.-coli-nissle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in HbA1c levels
Measured: 24 weeks
Secondary outcomes (4)
change in insulin resistance/secretion
Measured: 24 weeks
change in lipid parameters
Measured: 24 weeks
change in parameters of oxidative stress
Measured: 24 weeks
change in gastrointestinal condition
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Ardeypharm GmbH
- Responsible party
- Sponsor
- Investigators
- Antje Bergmann, Prof.Dr.med., Principal investigator, Carus Hausarztpraxis on behalf of GWT-TUD GmbHStefan R. Bornstein, Prof.Dr.med, Study chair, Universitätsklinikum Dresden on behalf of GWT-TUD GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144948
- Sponsor's protocol ID
- PUNiDIA-2014
- Acronym
- PUNiDIA
- Status last verified
- Aug 2015
- First submitted
- 20 May 2014
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate the Effect of E-coli-nissle as Probiotic Adjuvant to Antidiabetic Standard Care in Patients With Diabetes Mellitus Type II
- ClinicalTrials.gov ID
- NCT02144948
- Acronym / sponsor ID
- PUNiDIA / PUNiDIA-2014
- Conditions
- Diabetes Mellitus Type II
- Keywords
- diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Collaborators
- Ardeypharm GmbH
- Study start
- Aug 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to investigate the effect of e.-coli-nissle as supporting therapy to antidiabetic standard care in patients with diabetes mellitus type II
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E.-coli-Nissle | Experimental | Drug: e.-coli-nissle10 patients will be enrolled Intervention: E.-coli-Nissle (Mutaflor), oral suspension Dose: 1 ml / day frequency: qd |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diabetes mellitus type 2;
- HbA1c >7 % (stable für 6 months, max. variation of 0,5%)
- stable oral antidiabetic therapy for 6 months with Metformin, Vildagliptin, Gliniden or without oral Antidiabetics
- age of 45 to <80 years (men and women)
Key exclusion criteria (14 listed)
- Myocardial infarction or stroke within the last 5 years
- Therapy with acarbose
- Acute peripheral arterial disease within the last 12 months
- Instable metabolic situation
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e.-coli-nissleAlso: Mutaflor1 ml qd for 24 weeks | Drug | E.-coli-Nissle |
Primary outcome
Decrease in HbA1c levels
Time frame: 24 weeks
4 secondary outcomes
change in insulin resistance/secretion
Time frame: 24 weeks
change in lipid parameters
Time frame: 24 weeks
change in parameters of oxidative stress
Time frame: 24 weeks
change in gastrointestinal condition
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antje Bergmann, Prof.Dr.med. principal investigator
Carus Hausarztpraxis on behalf of GWT-TUD GmbH
Stefan R. Bornstein, Prof.Dr.med study chair
Universitätsklinikum Dresden on behalf of GWT-TUD GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing e.-coli-nissle in people with Diabetes Mellitus Type II, run by GWT-TUD GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in HbA1c levels (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.