Diabetes Mellitus, Type 2Phase 2NCT02150824
Safety and Tolerability, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Three Doses of BI 187004 Over 28 Days in Patients With Type 2 Diabetes Mellitus With and Without Metformin
A Phase 2 study testing BI 187004 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 3 sites in Germany.
Trial summary
Assess the safety and tolerability of once daily oral doses of BI 187004 in patients with type 2 diabetes mellitus without oral antidiabetic treatment and in patients on a stable metformin background treatment over 28 days. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- BI 187004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 3 sitesGermany
- Study dates
- Jul 2014to Aug 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or postmenopausal or hysterectomised female patients with diagnosis of Type 2 Diabetes Mellitus (T2DM) before informed consent
- To be eligible for Arm 1
- Oral antidiabetic mono-therapy for the last 12 weeks prior to Informed Consent AND Glycosylated haemoglobin (HbA1c) >= 6.5% and <= 8.5% at Visit 1a
- Therapy-naïve patients or no antidiabetic treatment within 4 weeks prior to Informed Consent AND HbA1c >= 7.0% and <= 9.5% at Visit 1a.
- To be eligible for Arm 2:
- Antidiabetic treatment with metformin with an unchanged daily dose for 12 weeks prior to Informed Consent AND patient´s willingness to keep this therapy stable during the course of the trial AND HbA1c >= 7.0% and <= 9.5% at Visit 1a
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- Age >=18 and <=80 years for female hysterectomised and male patients at Visit 1a
- Age >=55 and <=80 years for female postmenopausal (defined by the absence of menses for at least 2 years) patients at Visit 1a
- Body mass index (BMI) >= 28 and <= 40 kg/m2 at Visit 1a
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Who cannot join
- Treatment with a non-oral antidiabetic therapy or with more than one oral antidiabetic medication within 12 weeks prior to visit 1a.
- Fasted plasma glucose > 240 mg/dl (>13.3 mmol/l) on two consecutive days after screening (Visit 1a) confirmed by a fasted laboratory blood glucose test until first administration of the trial drug
- Any laboratory value more than 3 times above upper limit normal (ULN) at screening (visit 1a) or any other laboratory value outside the reference range and clinically relevant in the investigator judgment
- Any known clinically relevant concomitant diseases or chronic diseases other than type 2 diabetes, hyperlipidaemia or medically treated hypertension
- Medical history of cancer or treatment for cancer in the last five years prior to the Visit 1a.
- History of Cushing syndrome, Addison´s disease, congenital adrenal hyperplasia or polycystic ovary syndrome
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- Treatment with systemic, inhalatory or ophthalmologic steroids within 12 weeks prior to first administration of the trial drug.
- Treatment compliance during the run-in period is outside the per protocol range defined range, between 80%-120% treatment compliance.
- Use of any other concomitant medication within 5 half-lives before the first administration of the trial drug except for allowed co-medication.
- Surgery or trauma with significant blood loss (more than 500 ml) within the last 3 months prior to informed consent or blood donation (more than 100 ml) within four weeks prior to first administration of study medication or planned during the trial
- Any other medical condition that would interfere with trial participation based on investigator´s judgement or any on-going clinical condition that would jeopardize patient´s or site personnel´s safety or study compliance based on investigator judgement. Smoking habits interfering with hospitalization. Patients not willing to abstain from alcoholic beverages during inpatient visits
- Male patients not willing to use adequate contraception (sexual abstinence, condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until three months after the last intake
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
1307.4.49003 Boehringer Ingelheim Investigational Site
Berlin
1307.4.49002 Boehringer Ingelheim Investigational Site
Mainz
1307.4.49001 Boehringer Ingelheim Investigational Site
Neuss
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Groups Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Three BI 187004 Doses Given Once Daily as Mono-therapy and of the Highest BI 187004 Dose Given Once Daily as Add on Treatment to Metformin Over 28 Days in Patients With Type 2 Diabetes Mellitus
Assess the safety and tolerability of once daily oral doses of BI 187004 in patients with type 2 diabetes mellitus without oral antidiabetic treatment and in patients on a stable metformin background treatment over 28 days. Assess the effect on fasting plasma glucose after 28 days of treatment and to investigate the pharmacokinetics and pharmacodynamics of BI 187004.
- 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
BI 187004 high dose matching placebo once daily
PlaceboDrug
BI 187004 medium dose matching placebo once daily
PlaceboDrug
BI 187004 high dose matching placebo once daily add on to background metformin
BI 187004Drug
BI 187004 high dose once daily add on to background metformin
PlaceboDrug
BI 187004 low dose matching placebo once daily
BI 187004Drug
BI 187004 medium dose once daily
BI 187004Drug
BI 187004 low dose once daily
BI 187004Drug
BI 187004 high dose once daily
| Study group | Role | What they receive |
|---|---|---|
| BI 187004 low dose mono QD | Experimental | patient to receive one tablet containing low dose of BI 187004 or matching placebo Receives: Drug: Placebo; Drug: BI 187004 |
| BI 187004 medium dose mono QD | Experimental | patient to receive one tablet containing medium dose mg of BI 187004 or matching placebo Receives: Drug: Placebo; Drug: BI 187004 |
| BI 187004 high dose mono QD | Experimental | patient to receive one tablet containing high dose of BI 187004 or matching placebo Receives: Drug: Placebo; Drug: BI 187004 |
| BI 187004 high dose QD add on | Experimental | patient to receive one tablet containing high dose of BI 187004 or matching placebo add on to metformin background dose Receives: Drug: Placebo; Drug: BI 187004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with drug- related adverse events
Measured: 6 weeks
Secondary outcomes (1)
Change from baseline in fasting plasma glucose (FPG) after 28 days of treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 103 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
- NCT02150824
- Sponsor's protocol ID
- 1307.4
- Other IDs
- 2013-003646-16
- Status last verified
- Aug 2015
- First submitted
- 28 May 2014
- Last updated
- 14 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Groups Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Three BI 187004 Doses Given Once Daily as Mono-therapy and of the Highest BI 187004 Dose Given Once Daily as Add on Treatment to Metformin Over 28 Days in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02150824
- Acronym / sponsor ID
- 1307.4
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 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.
Assess the safety and tolerability of once daily oral doses of BI 187004 in patients with type 2 diabetes mellitus without oral antidiabetic treatment and in patients on a stable metformin background treatment over 28 days. Assess the effect on fasting plasma glucose after 28 days of treatment and to investigate the pharmacokinetics and pharmacodynamics of BI 187004.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BI 187004 low dose mono QD | Experimental | Drug: Placebo, Drug: BI 187004patient to receive one tablet containing low dose of BI 187004 or matching placebo |
| BI 187004 medium dose mono QD | Experimental | Drug: Placebo, Drug: BI 187004patient to receive one tablet containing medium dose mg of BI 187004 or matching placebo |
| BI 187004 high dose mono QD | Experimental | Drug: Placebo, Drug: BI 187004patient to receive one tablet containing high dose of BI 187004 or matching placebo |
| BI 187004 high dose QD add on | Experimental | Drug: Placebo, Drug: BI 187004patient to receive one tablet containing high dose of BI 187004 or matching placebo add on to metformin background dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or postmenopausal or hysterectomised female patients with diagnosis of Type 2 Diabetes Mellitus (T2DM) before informed consent
- To be eligible for Arm 1
- To be eligible for Arm 2:
- Age >=18 and <=80 years for female hysterectomised and male patients at Visit 1a
- Age >=55 and <=80 years for female postmenopausal (defined by the absence of menses for at least 2 years) patients at Visit 1a
Key exclusion criteria (12 listed)
- Treatment with a non-oral antidiabetic therapy or with more than one oral antidiabetic medication within 12 weeks prior to visit 1a.
- Fasted plasma glucose > 240 mg/dl (>13.3 mmol/l) on two consecutive days after screening (Visit 1a) confirmed by a fasted laboratory blood glucose test until first administration of the trial drug
- Any laboratory value more than 3 times above upper limit normal (ULN) at screening (visit 1a) or any other laboratory value outside the reference range and clinically relevant in the investigator judgment
- Any known clinically relevant concomitant diseases or chronic diseases other than type 2 diabetes, hyperlipidaemia or medically treated hypertension
- Medical history of cancer or treatment for cancer in the last five years prior to the Visit 1a.
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 |
|---|---|---|
| PlaceboBI 187004 high dose matching placebo once daily | Drug | BI 187004 high dose mono QD |
| PlaceboBI 187004 medium dose matching placebo once daily | Drug | BI 187004 medium dose mono QD |
| PlaceboBI 187004 high dose matching placebo once daily add on to background metformin | Drug | BI 187004 high dose QD add on |
| BI 187004BI 187004 high dose once daily add on to background metformin | Drug | BI 187004 high dose QD add on |
| PlaceboBI 187004 low dose matching placebo once daily | Drug | BI 187004 low dose mono QD |
| BI 187004BI 187004 medium dose once daily | Drug | BI 187004 medium dose mono QD |
| BI 187004BI 187004 low dose once daily | Drug | BI 187004 low dose mono QD |
| BI 187004BI 187004 high dose once daily | Drug | BI 187004 high dose mono QD |
Primary outcome
The percentage of patients with drug- related adverse events
Time frame: 6 weeks
1 secondary outcome
Change from baseline in fasting plasma glucose (FPG) after 28 days of treatment
Time frame: 4 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 Aug 2015.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 187004 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 3 sites 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 10 inclusion and 12 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 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
The percentage of patients with drug- related adverse events (time frame: 6 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 Aug 2015.