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

• ClinicalTrials.gov Identifier: NCT00354536
• Recruitment Status: Completed
• First Posted: July 20, 2006
• Last Update Posted: October 26, 2016
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: July 18, 2006
• First Posted Date: July 20, 2006
• Last Update Posted Date: October 26, 2016
• Study Start Date: February 2006
• Actual Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 4, 2007): blood plasma levels of GSK716155 [ Time Frame: on days 2 & 9 ]
• Original Primary Outcome Measures (submitted: July 18, 2006): Pharmacodynamic measurements during 7 days of dosing.
• Current Secondary Outcome Measures (submitted: September 4, 2007): blood plasma levels of GSK716155 [ Time Frame: on days 2 & 9 ]
• Original Secondary Outcome Measures (submitted: July 18, 2006): Pharmacokinetic measurements during 7 days of dosing.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus
• 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Diabetes Mellitus, Type 2

Intervention

• Drug: GSK716155 subcutaneous injections
  albiglutide subcutaneous injection
• Biological: placebo injection
  placebo injection
  Other Name: placebo

Study Arms

• Active Comparator: albiglutide
  albiglutide injection
  Intervention: Drug: GSK716155 subcutaneous injections
• Placebo Comparator: albiglutide placebo
  placebo injection
  Intervention: Biological: placebo injection

• Publications *: Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836. Review.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 18, 2006): 60
• Original Enrollment: Same as current
• Actual Study Completion Date: September 2006
• Actual Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00354536
• Other Study ID Numbers: GLP106073
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

• Responsible Party: GlaxoSmithKline
• Study Sponsor: GlaxoSmithKline
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: October 2016