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4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00558571
First received: November 14, 2007
Last updated: October 6, 2009
Last verified: October 2009
History of Changes
  Purpose

Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: BI 10773
Drug: placebo to BI 10773
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 4 Weeks Treatment With Three Oral Doses of BI 10773 as Tablets in Female and Male Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Safety and tolerability will be assessed [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Pharmacokinetic and pharmacodynamic endpoints will be determined on Day 1 and on Day 28 [ Time Frame: 4 weeks ]

Enrollment: 78
Study Start Date: January 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients with type 2 diabetes
  • Age >18 and < 70 years
  • BMI <18.5 and <40 kg/m2

Exclusion Criteria:

  • Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent;
  • Fasted blood glucose > 240 mg/dl (>13.3 mmol/L) or a blood glucose level above 400 mg/dl (22.2 mmol/L) postprandially;
  • HbA1c > 8.5 %
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558571

Locations
Germany
1245.4.49003 Boehringer Ingelheim Investigational Site
Berlin, Germany
1245.4.49002 Boehringer Ingelheim Investigational Site
Mainz, Germany
1245.4.49001 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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00558571     History of Changes
Other Study ID Numbers: 1245.4, EudraCT No 2007-002685-36
Study First Received: November 14, 2007
Last Updated: October 6, 2009
Health Authority: Germany: BfArM (Bundesagentur fuer Arzneimittel und Medizinalprodukte)

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 21, 2013