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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 135585 XX in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01282970
First received: January 24, 2011
Last updated: January 11, 2012
Last verified: January 2012
History of Changes
  Purpose

The objective of this study is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 135585 XX following multiple dose administration over 14 days


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: BI 135585
Drug: Placebo to BI 135585
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses (5 to 100 mg q.d. for 14 Days) of BI 135585 XX in Patients With Type 2 Diabetes Mellitus (Randomized, Double-blind Placebo-controlled Within Dose Groups)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Safety and tolerability of BI 135585 will be assessed in a descriptive way using physical examinations (occurence of findings), vital signs, electrocardiograms, laboratory tests, and incidence and severity of adverse events. [ Time Frame: up to 16 days post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterization of the pharmacokinetics of BI 135585 in plasma and urine following single and multiple dose oral administration [ Time Frame: up to 10 days post treatment ] [ Designated as safety issue: No ]
  • Exploratory evaluation of the pharmacodynamics of BI 135585 by determination of 11beta-hydroxysteroid dehydrogenase type 1 activity in adipose tissue (ex vivo) [ Time Frame: up to 24 hours post treatment ] [ Designated as safety issue: No ]
  • Exploratory evaluation of the pharmacodynamics of BI 135585 by measuring of cortisol and cortisone and their metabolites in urine [ Time Frame: up to 24 hours post treatment ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: February 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 135585
once daily doses as oral solution or tablet formulation over 14 days
 Drug: BI 135585
oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days
Placebo Comparator: Placebo to BI 135585
once daily doses as oral solution or tablet formulation over 14 days
 Drug: Placebo to BI 135585
oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Type 2 diabetes mellitus, current treatment with no more than one anti-diabetic drug, male or post-menopausal or surgically sterilised female, Body Mass Index 25-40 kg/m2

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282970

Locations
Germany
1283.2.1 Boehringer Ingelheim Investigational Site
Neuss, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01282970     History of Changes
Other Study ID Numbers: 1283.2, 2010-022698-32
Study First Received: January 24, 2011
Last Updated: January 11, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 19, 2013