Diabetes Mellitus, Type 2Phase 1NCT01874483
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 187004 in Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing BI 187004 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004 following multiple dose administration over 14 days. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- BI 187004
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2013to Dec 2013
- Phase
- Phase 1
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Current treatment with no more than one anti-diabetic drug (except for insulin and GLP-1 analogues)
- Males or post-menopausal or surgically sterilised females
- Age from 20 and to 70 years
- HbA1c less or equal to 8.5%
- BMI 28-40 kg/m2
- Subjects must be able to understand an comply with study requirements
Who cannot join
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal that the investigator considers to be of not acceptable clinical relevance
- Repeated measurement of systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 95 mm Hg
- Myocardial infarction, stroke or transient ischemic attack within 6 months prior to informed consent
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia or medically treated hypertension
- Surgery of the gastrointestinal tract that might affect absorption and elimination of the study drug
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy
- Chronic or relevant acute infections (e.g. HIV, hepatitis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 187004 CL in Patients With Type 2 Diabetes Mellitus (Randomized, Double-blind Placebo-controlled Within Dose Groups)
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004 following multiple dose administration over 14 days.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Placebo, BI 187004
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
placebo
BI 187004Drug
BI 187004, dose 2
BI 187004Drug
BI 187004, dose 4
BI 187004Drug
BI 187004, dose 5
BI 187004Drug
BI 187004, dose 6
BI 187004Drug
BI 187004, dose 7
BI 187004Drug
BI 187004, dose 1
BI 187004Drug
BI 187004, dose 3
| Study group | Role | What they receive |
|---|---|---|
| BI 187004 dose 1 | Experimental | multiple dose given over 14 days Receives: Drug: BI 187004 |
| BI 187004 dose 2 | Experimental | multiple dose given over 14 days Receives: Drug: BI 187004 |
| BI 187004 dose 3 | Experimental | multiple dose given over 14 days Receives: Drug: BI 187004 |
| BI 187004 dose 4 | Experimental | multiple dose given over 14 days Receives: Drug: BI 187004 |
| BI 187004 dose 5 | Experimental | multiple dose given over 14 days Receives: Drug: BI 187004 |
| BI 187004 dose 6 | Experimental | multiple dose given over 14 days Receives: Drug: BI 187004 |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
| BI 187004 dose 7 | Experimental | multiple dose given over 14 days Receives: Drug: BI 187004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events
Measured: up to 15 days postdose
Secondary outcomes (4)
AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)
Measured: up to 8 days postdose
Cmax t,1 (maximum measured concentration of the analyte in plasma after administration of the first dose)
Measured: up to 8 days postdose
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t)
Measured: up to 8 days postdose
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)
Measured: up to 8 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874483
- Sponsor's protocol ID
- 1307.2
- Other IDs
- 2013-000312-21
- Status last verified
- Jan 2016
- First submitted
- 7 Jun 2013
- Last updated
- 27 Jan 2016
- Results posted
- No
Publications
Bianzano S, Schepers C, Wolff M, Heise T, Plum-Moerschel L. Selective Inhibition of 11beta-Hydroxysteroiddehydrogenase-1 with BI 187004 in Patients with Type 2 Diabetes and Overweight or Obesity: Safety, Pharmacokinetics, and Pharmacodynamics After Multiple Dosing Over 14 Days. Exp Clin Endocrinol Diabetes. 2022 Dec;130(12):773-782. doi: 10.1055/a-1932-3136. Epub 2022 Nov 7.
PubMed 36343645
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 187004 CL in Patients With Type 2 Diabetes Mellitus (Randomized, Double-blind Placebo-controlled Within Dose Groups)
- ClinicalTrials.gov ID
- NCT01874483
- Acronym / sponsor ID
- 1307.2
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Jun 2013 (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.
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004 following multiple dose administration over 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| BI 187004 dose 1 | Experimental | Drug: BI 187004multiple dose given over 14 days |
| BI 187004 dose 2 | Experimental | Drug: BI 187004multiple dose given over 14 days |
| BI 187004 dose 3 | Experimental | Drug: BI 187004multiple dose given over 14 days |
| BI 187004 dose 4 | Experimental | Drug: BI 187004multiple dose given over 14 days |
| BI 187004 dose 5 | Experimental | Drug: BI 187004multiple dose given over 14 days |
| BI 187004 dose 6 | Experimental | Drug: BI 187004multiple dose given over 14 days |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
| BI 187004 dose 7 | Experimental | Drug: BI 187004multiple dose given over 14 days |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type 2 diabetes mellitus
- Current treatment with no more than one anti-diabetic drug (except for insulin and GLP-1 analogues)
- Males or post-menopausal or surgically sterilised females
- Age from 20 and to 70 years
- HbA1c less or equal to 8.5%
Key exclusion criteria (7 listed)
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal that the investigator considers to be of not acceptable clinical relevance
- Repeated measurement of systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 95 mm Hg
- Myocardial infarction, stroke or transient ischemic attack within 6 months prior to informed consent
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia or medically treated hypertension
- Surgery of the gastrointestinal tract that might affect absorption and elimination of the study drug
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 |
|---|---|---|
| Placeboplacebo | Drug | Placebo |
| BI 187004BI 187004, dose 2 | Drug | BI 187004 dose 2 |
| BI 187004BI 187004, dose 4 | Drug | BI 187004 dose 4 |
| BI 187004BI 187004, dose 5 | Drug | BI 187004 dose 5 |
| BI 187004BI 187004, dose 6 | Drug | BI 187004 dose 6 |
| BI 187004BI 187004, dose 7 | Drug | BI 187004 dose 7 |
| BI 187004BI 187004, dose 1 | Drug | BI 187004 dose 1 |
| BI 187004BI 187004, dose 3 | Drug | BI 187004 dose 3 |
Primary outcome
Occurrence of adverse events
Time frame: up to 15 days postdose
4 secondary outcomes
AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)
Time frame: up to 8 days postdose
Cmax t,1 (maximum measured concentration of the analyte in plasma after administration of the first dose)
Time frame: up to 8 days postdose
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t)
Time frame: up to 8 days postdose
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)
Time frame: up to 8 days postdose
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 27 Jan 2016.
- Derived from this study: PubMed 36343645Bianzano S, Schepers C, Wolff M, Heise T, Plum-Moerschel L. Selective Inhibition of 11beta-Hydroxysteroiddehydrogenase-1 with BI 187004 in Patients with Type 2 Diabetes and Overweight or Obesity: Safety, Pharmacokinetics, and Pharmacodynamics After Multiple Dosing Over 14 Days. Exp Clin Endocrinol Diabetes. 2022 Dec;130(12):773-782. doi: 10.1055/a-1932-3136. Epub 2022 Nov 7.
- Related InfoLink provided by the sponsor.
Related trials for Diabetes Mellitus, Type 2
RecruitingObservational study
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruiting
Enhancing Telemedicine for T2D
Type 2 Diabetes
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 187004 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim 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 7 inclusion and 7 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 27 Jan 2016. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Occurrence of adverse events (time frame: up to 15 days postdose). 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 NCT01874483, 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 27 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.