A Study to Test How SB756050 Affects Subjects With Type 2 Diabetes Mellitus After 6 Days of Dosing.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00733577
First received: August 12, 2008
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

This is an escalating dose study in subjects with T2DM, which will consist of four overlapping cohorts receiving 6 days of SB756050 to assess safety, pharmacokinetics, and pharmacodynamics.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: SB756050
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Single-blinded Randomized, Placebo-controlled, Staggered-parallel, Escalating-dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral SB756050 Administered for 6 Days to Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Safety measures including: AEs daily; laboratory testing: day -1,2,5,7 and follow up; ECG: day -1, 2, 5, 6, 7 and follow-up; vital signs: daily; PK parameters day -1,5, and 6. [ Time Frame: 6 days of dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacodynamic endpoints will include fasting and meal or OGTT-related weighted mean AUC for glucose, GLP-1 (total and active), glucagon, insulin, PYY (active) and C-peptide levels. [ Time Frame: 6 days of dosing ] [ Designated as safety issue: No ]
  • Safety and tolerability parameters including adverse events, clinical laboratory, ECGs and vital signs assessments. [ Time Frame: 6 days of dosing ] [ Designated as safety issue: Yes ]
  • Subject reports of hunger and craving as reported on the Hunger and Craving questionnaire [ Time Frame: 6 days of dosing ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
15 mg SB756050 or placebo
Drug: SB756050
doses are planned to be 15mg to 600mg doses may be altered based on plasma concentrations
Other Name: SB756050
Experimental: Cohort 2
Planned dose for Cohorts 2 50mg SB756050 or placebo
Drug: SB756050
doses are planned to be 15mg to 600mg doses may be altered based on plasma concentrations
Other Name: SB756050
Experimental: Cohort 3
Planned dose for Cohort 3 150mg SB756050 or placebo
Drug: SB756050
doses are planned to be 15mg to 600mg doses may be altered based on plasma concentrations
Other Name: SB756050
Experimental: Cohort 4
Planned dose for Cohort 4 600mg SB756050 or placebo
Drug: SB756050
doses are planned to be 15mg to 600mg doses may be altered based on plasma concentrations
Other Name: SB756050

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects, 18 - 60 years of age, inclusive, at the time of signing the informed consent
  • A female subject is eligible to participate if she is of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. FSH and estradiol levels will be checked at Screening for postmenopausal women. Simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory.
  • Except as noted elsewhere, subjects should have no significant known medical conditions other than T2DM, as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECGs. A subject with a clinical abnormality or laboratory parameters that meets exclusion criteria but is outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • BMI (body mass index) within the range 25-35 kg/m2, inclusive.
  • T2DM diagnosed at least 3 months prior to Screening
  • Subjects must be treating their T2DM using one of the following regimens: Diet and exercise therapy, Metformin as monotherapy, Sulfonylurea as monotherapy, Metformin and sulfonylurea in combination, DPP-IV inhibitors, either as monotherapy or in combination with other agent(s) on this list at half maximal dose or less, Exenatide, either as monotherapy or in combination with other agent(s) on this list All doses of anti-diabetic medication must have been stable for at least 3 months prior to Screening, and the subject must be willing to wash out from their antidiabetic medications from Day -7 through Day 7.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

  • Has positive pre-study Hepatitis B surface antigen or positive Hepatitis C, result within 3 months of screening. Positive test for HIV antibody. History of uncorrected thyroid dysfunction. ALT and/or AST > 2 times the upper limit of normal at screening. Fasting triglycerides > 450mg/dL at screening. Total Bilirubin > 1.5 times the upper limit of normal at screening. A positive pre-study drug/urine screen and tobacco screen.
  • Significant renal disease
  • Significant ECG abnormalities
  • Systolic pressure > 150 mmHg or <80 mmHg or diastolic blood pressure > 95 mmHg or <60 mmHg at screening.
  • Previous use of insulin as a treatment within 3 months of Screening, or for >2 weeks when used for acute illness in the last 12 months prior to Screening, or if used for more than 1 year when associated with GDM.
  • Has a history of gastrointestinal disease that could affect absorption within the past year, Gastrointestinal surgery, Chronic or acute pancreatitis.
  • History of regular alcohol consumption
  • Smoked or used tobacco or nicotine-containing products within the previous 6 months.
  • Has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Is taking prohibited medications.
  • Unwilling to abstain from caffeine-or xanthine-containing products for 24 hours prior to dosing until Day 7, Use of illicit drugs or nicotine-containing products, Alcohol for 24 hours prior to dosing until Day 7, Consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication until collection of the final pharmacokinetic blood samples
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. This includes sensitivity to heparin, if heparin will be used to maintain catheter patency.
  • Where participation in the study would result in donation of blood in excess of 500 mL within a 56 day period.
  • Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733577

Locations
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33169
GSK Investigational Site
Orlando, Florida, United States, 32809
United States, New Jersey
GSK Investigational Site
Hackensack, New Jersey, United States, 07601
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00733577     History of Changes
Other Study ID Numbers: 111829
Study First Received: August 12, 2008
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
diabetes
pharmacodynamics
safety
pharmacokinetics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 01, 2014