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OpenTrials
Completed

NCT Number: NCT01874483

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

To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004 following multiple dose administration over 14 days.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1307.2.1 Boehringer Ingelheim Investigational Site

Neuss, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Placebo

Drug

placebo

BI 187004

Drug

BI 187004, dose 2

Primary outcomes

  1. Occurrence of adverse events

    Time frame: up to 15 days postdose

Secondary outcomes

  1. 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

  2. Cmax t,1 (maximum measured concentration of the analyte in plasma after administration of the first dose)

    Time frame: up to 8 days postdose

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2013
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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