Last updated: 11/04/2018 07:57:55
Clinical assessment of GSK716155 for Type 2 Diabetes Mellitus
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: A Phase I/II study to investigate the safety, pharmacokinetics and pharmacodynamics of GSK716155 in Japanese subjects with type 2 diabetes mellitus
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Plasma concentrations and PD parameters over time and at the end of study
Timeframe: Up to Week 9
Secondary outcomes:
Other metabolic parameters at the end of study
Timeframe: Up to Week 9
Interventions:
Drug: GSK716155 for injection
Drug: Placebo
Enrollment:
40
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Yutaka Seino, Hiromu Nakajima, Hajima Miyahara, Takashi Kurita, Mark Bush, Fred Yang, and Murray Stewart for the Albiglutide Study Group.Safety, tolerability, pharmacokinetics and pharmacodynamics of albiglutide, a long-acting GLP 1-receptor agonist in Japanese subjects with type 2 diabetes mellitus.Current Medical Research and Opinion; Published online 29th October 2009; doi:10.1185/03007990903372999.2009;29(12):3049–3057;
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Not applicable
Study date(s)
August 2007 to April 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
20 - 70 years
Accepts healthy volunteers
No
- 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.
- Positive test result for either syphilis, HBs antigen, HCV antibody, HIV antigen/antibody, or HTLV-1 antibody.
- Clinically significant hepatic enzyme elevation.
Inclusion and exclusion criteria
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-17-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study GLP107865 can be found on the GSK Clinical Study Register.
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