Last updated: 11/07/2018 17:13:09
In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A single-blinded randomized, placebo-controlled, staggered-parallel, escalating-dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in Subjects with type 2 Diabetes Mellitus
Trial description: This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is given at the same dose 7 days apart, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
blood plasma levels of GSK716155
Timeframe: on days 2 & 9
Secondary outcomes:
blood plasma levels of GSK716155
Timeframe: on days 2 & 9
Interventions:
Drug: GSK716155 subcutaneous injections
Biological/vaccine: placebo injection
Enrollment:
60
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Jessica E. Matthews, Murray W. Stewart, Erika H. De Boever, Robert L. Dobbins, Rebecca J. Hodge, Susan E. Walker, M. Claire Holland, Mark A. Bush, for the Albiglutide Study Group . Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Albiglutide, a Long-Acting Glucagon-Like Peptide-1 Mimetic, in Patients with Type 2 Diabetes. The Journal of Clinical Endocrinology & Metabolism. 2008;93(12):4810-4817.
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Not applicable
Study date(s)
February 2006 to September 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
No
- Subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months.
- Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea.
- Laboratory values that meet certain criteria (for example, total cholesterol > 240 mg/dL).
- Clinically significant hepatic enzyme elevation.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months.
- Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea.
- Subjects must be willing to wash-out of these medications for 14 days prior to the start of the study.
- Subjects must have a BMII between 25 and 40 kg/m² and weigh at leas 50kg.
- Women must be of non-childbearing potential.
Exclusion criteria:
- Laboratory values that meet certain criteria (for example, total cholesterol > 240 mg/dL).
- Clinically significant hepatic enzyme elevation.
- Fasting plasma glucose greater than 240mg/dL.
- Positive test result for Hepatitis B surface antigen, positive Hepatitis C or HIV.
- Any major illness other than diabetes.
- Previous use of insulin as treatment for diabetes.
- Significant renal disease as defined by screening lab tests.
- History of drug or other allergy, which in the opinion of the investigator contradicts subject participation.
- Smoking or use of nicotine-containing products within the previous 6 months.
- History of alcohol or drug abuse.
- Unwilling to abstain from alcohol during the study.
- Unwilling to abstain from caffeine- or xanthine-containing products during the study.
- Use of St. John's Wort during the study.
- Has donated 500 nL or more blood within 56 days of dosing or plans to donate blood in the month following study participation.
- Previously received any GLP-1 mimetic that has moe than 70% sequence homology to GLP-1.
Trial location(s)
Location
GSK Investigational Site
Portland, Oregon, United States, 97239
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Orlando, Florida, United States, 32809
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96814-4224
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Miramar, Florida, United States, 33025
Status
Terminated/Withdrawn
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
2006-25-09
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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