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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01874483
First received: June 7, 2013
Last updated: January 26, 2016
Last verified: January 2016
  Purpose
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004 following multiple dose administration over 14 days.

Condition Intervention Phase
Diabetes Mellitus, Type 2 Drug: Placebo Drug: BI 187004 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Occurrence of adverse events [ Time Frame: up to 15 days postdose ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 71
Study Start Date: June 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 187004 dose 1
multiple dose given over 14 days
Drug: BI 187004
BI 187004, dose 1
Experimental: BI 187004 dose 2
multiple dose given over 14 days
Drug: BI 187004
BI 187004, dose 2
Experimental: BI 187004 dose 3
multiple dose given over 14 days
Drug: BI 187004
BI 187004, dose 3
Experimental: BI 187004 dose 4
multiple dose given over 14 days
Drug: BI 187004
BI 187004, dose 4
Experimental: BI 187004 dose 5
multiple dose given over 14 days
Drug: BI 187004
BI 187004, dose 5
Experimental: BI 187004 dose 6
multiple dose given over 14 days
Drug: BI 187004
BI 187004, dose 6
Placebo Comparator: Placebo
placebo
Drug: Placebo
placebo
Experimental: BI 187004 dose 7
multiple dose given over 14 days
Drug: BI 187004
BI 187004, dose 7

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874483

Locations
Germany
1307.2.1 Boehringer Ingelheim Investigational Site
Neuss, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01874483     History of Changes
Other Study ID Numbers: 1307.2
2013-000312-21 ( EudraCT Number: EudraCT )
Study First Received: June 7, 2013
Last Updated: January 26, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 21, 2017