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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00530309 |
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Date of registration:
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14/09/2007 |
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Primary sponsor: |
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Public title:
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Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus
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Scientific title:
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Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus -A Phase I/II Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of GSK716155 in Japanese Subjects With Type 2 Diabetes Mellitus- |
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Date of first enrolment:
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August 2007 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00530309 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Type 2 diabetes mellitus diagnosed at least 3 months with FPG level <=240mg/dL and
HbA1c between 6.5% and 10% inclusive.
- Must be diet controlled - OR - taking a single oral antidiabetic agent (other than
thiazolidinediones) and willing to withdraw from this treatment from 2 weeks prior to
the study.
- Must have a BMI:<=35kg/m2, 20 to 70 years of age inclusive.
- Woman must be of non-childbearing potential.
Exclusion criteria:
- Positive test result for either syphilis, HBs antigen, HCV antibody, HIV
antigen/antibody, or HTLV-1 antibody.
- Clinically significant hepatic enzyme elevation.
- History of metabolic disease other than T2DM.
- Previous use of insulin as a treatment for diabetes within 3 months.
- History of severe gastrointestinal disease.
- Clinically significant cardiovascular disease.
- Significant renal disease as defined by screening lab test.
- History of drug (including albumin or albumin containing agents) allergy.
- History of alcohol or drug abuse.
- Donation of blood in excess of 400mL within previous 4 months.
- Previously received any GLP-1 mimetic or any other albumin-containing products.
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Type 2 Diabetes Mellitus
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Intervention(s)
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Drug: GSK716155 for injection
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Primary Outcome(s)
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Plasma concentrations and PD parameters over time and at the end of study
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Secondary Outcome(s)
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Other metabolic parameters at the end of study
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Secondary ID(s)
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GLP107865
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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