Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 187004 in Patients With Type 2 Diabetes Mellitus

January 26, 2016 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 1

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

  • Germany
      • Neuss, Germany
        • 1307.2.1 Boehringer Ingelheim Investigational Site

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Type 2 diabetes mellitus
  2. Current treatment with no more than one anti-diabetic drug (except for insulin and GLP-1 analogues)
  3. Males or post-menopausal or surgically sterilised females
  4. Age from 20 and to 70 years
  5. HbA1c less or equal to 8.5%
  6. BMI 28-40 kg/m2
  7. Subjects must be able to understand an comply with study requirements

Exclusion criteria:

  1. 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
  2. Repeated measurement of systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 95 mm Hg
  3. Myocardial infarction, stroke or transient ischemic attack within 6 months prior to informed consent
  4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia or medically treated hypertension
  5. Surgery of the gastrointestinal tract that might affect absorption and elimination of the study drug
  6. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy
  7. Chronic or relevant acute infections (e.g. HIV, hepatitis)

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
Placebo Comparator: Placebo
placebo
Drug: Placebo
placebo
Experimental: BI 187004 dose 1
multiple dose given over 14 days
Drug: BI 187004
BI 187004, dose 2
Drug: BI 187004
BI 187004, dose 4
Drug: BI 187004
BI 187004, dose 5
Drug: BI 187004
BI 187004, dose 6
Drug: BI 187004
BI 187004, dose 7
Drug: BI 187004
BI 187004, dose 1
Drug: BI 187004
BI 187004, dose 3
Experimental: BI 187004 dose 2
multiple dose given over 14 days
Drug: BI 187004
BI 187004, dose 2
Drug: BI 187004
BI 187004, dose 4
Drug: BI 187004
BI 187004, dose 5
Drug: BI 187004
BI 187004, dose 6
Drug: BI 187004
BI 187004, dose 7
Drug: BI 187004
BI 187004, dose 1
Drug: BI 187004
BI 187004, dose 3
Experimental: BI 187004 dose 3
multiple dose given over 14 days
Drug: BI 187004
BI 187004, dose 2
Drug: BI 187004
BI 187004, dose 4
Drug: BI 187004
BI 187004, dose 5
Drug: BI 187004
BI 187004, dose 6
Drug: BI 187004
BI 187004, dose 7
Drug: BI 187004
BI 187004, dose 1
Drug: BI 187004
BI 187004, dose 3
Experimental: BI 187004 dose 4
multiple dose given over 14 days
Drug: BI 187004
BI 187004, dose 2
Drug: BI 187004
BI 187004, dose 4
Drug: BI 187004
BI 187004, dose 5
Drug: BI 187004
BI 187004, dose 6
Drug: BI 187004
BI 187004, dose 7
Drug: BI 187004
BI 187004, dose 1
Drug: BI 187004
BI 187004, dose 3
Experimental: BI 187004 dose 5
multiple dose given over 14 days
Drug: BI 187004
BI 187004, dose 2
Drug: BI 187004
BI 187004, dose 4
Drug: BI 187004
BI 187004, dose 5
Drug: BI 187004
BI 187004, dose 6
Drug: BI 187004
BI 187004, dose 7
Drug: BI 187004
BI 187004, dose 1
Drug: BI 187004
BI 187004, dose 3
Experimental: BI 187004 dose 6
multiple dose given over 14 days
Drug: BI 187004
BI 187004, dose 2
Drug: BI 187004
BI 187004, dose 4
Drug: BI 187004
BI 187004, dose 5
Drug: BI 187004
BI 187004, dose 6
Drug: BI 187004
BI 187004, dose 7
Drug: BI 187004
BI 187004, dose 1
Drug: BI 187004
BI 187004, dose 3
Experimental: BI 187004 dose 7
multiple dose given over 14 days
Drug: BI 187004
BI 187004, dose 2
Drug: BI 187004
BI 187004, dose 4
Drug: BI 187004
BI 187004, dose 5
Drug: BI 187004
BI 187004, dose 6
Drug: BI 187004
BI 187004, dose 7
Drug: BI 187004
BI 187004, dose 1
Drug: BI 187004
BI 187004, dose 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of adverse events
Time Frame: up to 15 days postdose
up to 15 days postdose

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
up to 8 days postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

June 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 7, 2013

First Submitted That Met QC Criteria

June 7, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1307.2
  • 2013-000312-21 (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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