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A Study to Assess the Safety of Single Doses of GSK189075 in Subjects With Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00575159
First Posted: December 18, 2007
Last Update Posted: May 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
The purpose of this research study is to look at concentrations of GSK189075 in blood when single doses of the drug are taken by mouth in combination with basal insulin. The clinical effects of the drug in combination with insulin on the body will also be studied. The results will help determine doses of GSK189075 can be studied in the future in the type I diabetes mellitus population.

Condition Intervention Phase
Diabetes Mellitus, Type 1 Type 1 Diabetes Mellitus Drug: GSK189075 Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Single Ascending Dose Escalation, Placebo-controlled, Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK189075 Administered to Subjects With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • blood & urine samples: [ Time Frame: day 1 ]

Secondary Outcome Measures:
  • Adverse events, heart rate, blood pressure, ECG, clinical laboratory tests: [ Time Frame: screening, check-in, day 1,follow-up ]

Enrollment: 14
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm a
GSK189075
Drug: GSK189075
investigational drug
Placebo Comparator: Arm b
Placebo
Drug: placebo
placebo comparator
Other Name: GSK189075

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male/female, 18 to 55 years old
  • Diagnosis of type 1 diabetes mellitus for at least 6 months; and using a continuous insulin pump
  • Willing and able to follow all study-related instructions provided by the site staff.
  • Willing to provide signed informed consent.

Exclusion Criteria:

  • Pregnant or a nursing female.
  • Have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.
  • Have HIV or hepatitis, or have alcohol or drugs in your system at the screening visit.
  • Have a history of alcohol abuse or have an eating disorder
  • Have been in another research study in the last month or have taken certain medications in the 1 week before study drug would be taken.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575159


Locations
United States, California
GSK Investigational Site
San Diego, California, United States, 92161
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00575159     History of Changes
Other Study ID Numbers: KGI107465
First Submitted: December 14, 2007
First Posted: December 18, 2007
Last Update Posted: May 21, 2013
Last Verified: May 2013

Keywords provided by GlaxoSmithKline:
Adult male and females,
type 1 Diabetes mellitus, pharmacokinetics,
pharmacodynamics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases


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