In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: GSK716155 subcutaneous injections
* Biological: placebo injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: albiglutide<br>albiglutide injection | Drug: GSK716155 subcutaneous injections<br>* albiglutide subcutaneous injection<br>|
| Placebo Comparator: albiglutide placebo<br>placebo injection | Biological: placebo injection<br>* placebo injection<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood plasma levels of GSK716155 |  | on days 2 & 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood plasma levels of GSK716155 |  | on days 2 & 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GSK716155, albiglutide, pharmacodynamics, pharmacokinetics