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 8, 2014
Last verified: January 2014

June 7, 2013
January 8, 2014
June 2013
December 2013   (final data collection date for primary outcome measure)
Occurrence of adverse events [ Time Frame: up to 15 days postdose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01874483 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Cmax t,1 (maximum measured concentration of the analyte in plasma after administration of the first dose) [ Time Frame: up to 8 days postdose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 187004 in Patients With Type 2 Diabetes Mellitus
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo
    placebo
  • 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 1
    multiple dose given over 14 days
    Intervention: Drug: BI 187004
  • Experimental: BI 187004 dose 2
    multiple dose given over 14 days
    Intervention: Drug: BI 187004
  • Experimental: BI 187004 dose 3
    multiple dose given over 14 days
    Intervention: Drug: BI 187004
  • Experimental: BI 187004 dose 4
    multiple dose given over 14 days
    Intervention: Drug: BI 187004
  • Experimental: BI 187004 dose 5
    multiple dose given over 14 days
    Intervention: Drug: BI 187004
  • Experimental: BI 187004 dose 6
    multiple dose given over 14 days
    Intervention: Drug: BI 187004
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: Placebo
  • Experimental: BI 187004 dose 7
    multiple dose given over 14 days
    Intervention: Drug: BI 187004
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
December 2013
December 2013   (final data collection date for primary outcome measure)

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)
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01874483
1307.2, 2013-000312-21
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP