Type 2 Diabetes MellitusPhase 2NCT01547897
NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
A Phase 2 study testing NOX-E36 in people with Type 2 Diabetes Mellitus and Albuminuria, run by TME Pharma AG at 24 sites in 5 countries.
Trial summary
Primary objective: To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (ACR) in patients with type 2 diabetes and albuminuria Secondary objectives: To characterize the effect of study drug on glycosylated hemoglobin fraction (HbA1c) To evaluate the effect of study drug on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Albuminuria
- What is being tested?
- NOX-E36
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 24 sitesin 5 countries
- Study dates
- Mar 2012to Dec 2013
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus according to American Diabetes Association (ADA) definition
- Age ≥ 18
- HbA1c between 6.0% and 10.5%, inclusive
- ACR > 100 mg/g calculated 3 times in first morning void urine, at least 2 of the measurements > 100 mg/g
- Patients on stable (unchanged medication for at least 3 months) treatment to control hypertension, hyperglycemia and (if applicable) dyslipidemia
- Stable treatment with angiotensin-converting enzyme inhibitors (ACEi) and/or Angiotensin II receptor blockers (ARBs) (renin-angiotensin system [RAS] blockade)
- Willing and able to understand and sign an approved Informed Consent form
- Men must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment. Women must be of non-childbearing potential.
Who cannot join
- Type 1 diabetes mellitus
- Estimated Glomerular Filtration Rate (eGFR) ≤25 mL/min/1.73m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
- Recent cardiovascular events (3 months)
- Uncontrolled hypertension (upper limits 180/110 mmHg)
- Dialysis and/or acute kidney injury within 3 months before screening
- Significant edema, infectious diseases, leg ulcers
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- Severe concurrent disease which, in the judgment of the investigator, would interfere significantly with the assessments of safety and efficacy during this study
- Treatment with any other investigational agent, or participation in another clinical study within 90 days prior to baseline visit
- Patient with known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
- In the judgment of the clinical investigator, clinically significant abnormal laboratory values at the screening visit
- Use of thiazolidinedione class drugs, immune suppressants, steroid therapy (except for topical use or inhalation), chronic use of non-steroidal anti-inflammatory drug (NSAIDs), cyclooxygenase type 2 (COX-2) inhibitors, two or more diuretic drugs and/or aliskiren
- In the judgment of the clinical investigator, patients who are likely to be non-compliant or uncooperative during the study.
- Previous participation in this study.
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
Germany10 sites
Study site
Aschaffenburg
Study site
Dortmund
Study site
Düsseldorf
Study site
Hanover
Study site
Kronberg
Study site
Mainz
Study site
Mannheim
Study site
Offenbach
Study site
Schwabenheim
Study site
Witten
Hungary6 sites
Study site
Balatonfüred
Study site
Budapest
Study site
Gyula
Study site
Miskolc
Study site
Pécs
Study site
Szeged
Poland4 sites
Study site
Bialystok
Study site
Grodzisk Mazowiecki
Study site
Katowice
Study site
Warsaw
About this study
Official title: A Phase IIa Study to Characterize the Effects of CCL2 Inhibition With the Spiegelmer® NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
Primary objective:
- To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (ACR) in patients with type 2 diabetes and albuminuria
Secondary objectives:
- To characterize the effect of study drug on glycosylated hemoglobin fraction (HbA1c)
- To evaluate the effect of study drug on markers of glycemic disorders, systemic inflammation, renal and liver disease and cardiovascular function
- To assess the safety and tolerability of study drug
- To determine the population pharmacokinetics (PK) of study drug
- Conditions
- Type 2 Diabetes Mellitus, Albuminuria
- Being tested
- NOX-E36
- Medical subject headings
- Diabetes Mellitus, Type 2, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOX-E36Drug
0.5 mg/kg study drug or placebo as SC injections twice a week
| Study group | Role | What they receive |
|---|---|---|
| NOX-E36 | Active comparator | Not described Receives: Drug: NOX-E36 |
| Placebo | Placebo comparator | Not described Receives: Drug: NOX-E36 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of NOX-E36 on albuminuria as measured by ACR (albumin to creatinine ratio; mg/g)
ACR calculated in first morning void urine; comparison of patients treated with NOX-E36 versus placebo
Measured: Change versus baseline after 12 weeks treatment
Secondary outcomes (4)
Effect of NOX-E36 on hsCRP
Comparison of patients treated with NOX-E36 versus placebo
Measured: Change versus baseline after 12 weeks treatment
Effect of NOX-E36 on HbA1C
Comparison of patients treated with NOX-E36 versus placebo
Measured: Change versus baseline after 12 weeks treatment
Effect of NOX-E36 on HOMA-IR
Comparison of patients treated with NOX-E36 versus placebo
Measured: Change versus baseline after 12 weeks treatment
Effect of NOX-E36 on eGFR
eGFR will be calculated by the CKD-EPI equation using creatinine and cystatin C
Comparison of patients treated with NOX-E36 versus placebo
Measured: Change versus baseline after 12 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- TME Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kai Riecke, MD, Study director, Noxxon AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547897
- Sponsor's protocol ID
- SNOXE36C301
- Other IDs
- 2011-005710-11
- Status last verified
- Sep 2013
- First submitted
- 27 Feb 2012
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
PubMed 30957581
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Study to Characterize the Effects of CCL2 Inhibition With the Spiegelmer® NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
- ClinicalTrials.gov ID
- NCT01547897
- Acronym / sponsor ID
- SNOXE36C301
- Conditions
- Type 2 Diabetes Mellitus, Albuminuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- TME Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Mar 2012 (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.
Primary objective:
- To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (ACR) in patients with type 2 diabetes and albuminuria
Secondary objectives:
- To characterize the effect of study drug on glycosylated hemoglobin fraction (HbA1c)
- To evaluate the effect of study drug on markers of glycemic disorders, systemic inflammation, renal and liver disease and cardiovascular function
- To assess the safety and tolerability of study drug
- To determine the population pharmacokinetics (PK) of study drug
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOX-E36 | Active comparator | Drug: NOX-E36 |
| Placebo | Placebo comparator | Drug: NOX-E36 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetes mellitus according to American Diabetes Association (ADA) definition
- Age ≥ 18
- HbA1c between 6.0% and 10.5%, inclusive
- ACR > 100 mg/g calculated 3 times in first morning void urine, at least 2 of the measurements > 100 mg/g
- Patients on stable (unchanged medication for at least 3 months) treatment to control hypertension, hyperglycemia and (if applicable) dyslipidemia
Key exclusion criteria (13 listed)
- Type 1 diabetes mellitus
- Estimated Glomerular Filtration Rate (eGFR) ≤25 mL/min/1.73m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula)
- Recent cardiovascular events (3 months)
- Uncontrolled hypertension (upper limits 180/110 mmHg)
- Dialysis and/or acute kidney injury within 3 months before screening
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 |
|---|---|---|
| NOX-E360.5 mg/kg study drug or placebo as SC injections twice a week | Drug | NOX-E36, Placebo |
Primary outcome
Effect of NOX-E36 on albuminuria as measured by ACR (albumin to creatinine ratio; mg/g)
Time frame: Change versus baseline after 12 weeks treatment
ACR calculated in first morning void urine; comparison of patients treated with NOX-E36 versus placebo
4 secondary outcomes
Effect of NOX-E36 on hsCRP
Time frame: Change versus baseline after 12 weeks treatment
Effect of NOX-E36 on HbA1C
Time frame: Change versus baseline after 12 weeks treatment
Effect of NOX-E36 on HOMA-IR
Time frame: Change versus baseline after 12 weeks treatment
Effect of NOX-E36 on eGFR
Time frame: Change versus baseline after 12 weeks treatment
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 24 Feb 2014.
- Derived from this study: PubMed 30957581Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
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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.
Kai Riecke, MD study director
Noxxon AG
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NOX-E36 in people with Type 2 Diabetes Mellitus and Albuminuria, run by TME Pharma AG at 24 sites in 5 countries.
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 8 inclusion and 13 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 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, Hungary, Poland, Romania, Czechia. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Effect of NOX-E36 on albuminuria as measured by ACR (albumin to creatinine ratio; mg/g) (time frame: Change versus baseline after 12 weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01547897, which also lists 1 linked publication.
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 24 Feb 2014.