- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02150824
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
August 12, 2015 updated by: Boehringer Ingelheim
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany
- 1307.4.49003 Boehringer Ingelheim Investigational Site
-
Mainz, Germany
- 1307.4.49002 Boehringer Ingelheim Investigational Site
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Neuss, Germany
- 1307.4.49001 Boehringer Ingelheim Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- 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:
a. 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
- 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
Exclusion criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BI 187004 low dose mono QD
patient to receive one tablet containing low dose of BI 187004 or matching placebo
|
BI 187004 high dose matching placebo once daily
BI 187004 medium dose matching placebo once daily
BI 187004 high dose matching placebo once daily add on to background metformin
BI 187004 high dose once daily add on to background metformin
BI 187004 low dose matching placebo once daily
BI 187004 medium dose once daily
BI 187004 low dose once daily
BI 187004 high dose once daily
|
Experimental: BI 187004 medium dose mono QD
patient to receive one tablet containing medium dose mg of BI 187004 or matching placebo
|
BI 187004 high dose matching placebo once daily
BI 187004 medium dose matching placebo once daily
BI 187004 high dose matching placebo once daily add on to background metformin
BI 187004 high dose once daily add on to background metformin
BI 187004 low dose matching placebo once daily
BI 187004 medium dose once daily
BI 187004 low dose once daily
BI 187004 high dose once daily
|
Experimental: BI 187004 high dose mono QD
patient to receive one tablet containing high dose of BI 187004 or matching placebo
|
BI 187004 high dose matching placebo once daily
BI 187004 medium dose matching placebo once daily
BI 187004 high dose matching placebo once daily add on to background metformin
BI 187004 high dose once daily add on to background metformin
BI 187004 low dose matching placebo once daily
BI 187004 medium dose once daily
BI 187004 low dose once daily
BI 187004 high dose once daily
|
Experimental: BI 187004 high dose QD add on
patient to receive one tablet containing high dose of BI 187004 or matching placebo add on to metformin background dose
|
BI 187004 high dose matching placebo once daily
BI 187004 medium dose matching placebo once daily
BI 187004 high dose matching placebo once daily add on to background metformin
BI 187004 high dose once daily add on to background metformin
BI 187004 low dose matching placebo once daily
BI 187004 medium dose once daily
BI 187004 low dose once daily
BI 187004 high dose once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The percentage of patients with drug- related adverse events
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in fasting plasma glucose (FPG) after 28 days of treatment
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
May 28, 2014
First Submitted That Met QC Criteria
May 29, 2014
First Posted (Estimate)
May 30, 2014
Study Record Updates
Last Update Posted (Estimate)
August 14, 2015
Last Update Submitted That Met QC Criteria
August 12, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1307.4
- 2013-003646-16 (EudraCT Number: EudraCT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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