A Study of GSK256073 in Subjects With Type 2 Diabetes Mellitus Who Are Being Treated With Metformin

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The aim of this combined, two part study is to evaluate the safety and glucose lowering effects of GSK256073 when administered to diabetic subjects for 12 weeks.

Key facts

Study ID: NCT01376323
Run by: GlaxoSmithKline
People needed: 92
Starts: 2011-07-13
Expected to finish: 2012-09-17
Last updated by the study team: 2017-10-11

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

A diagnosis of T2DM as determined by a responsible physician based on a medical evaluation including medical history, physical examination, and laboratory tests, with onset at least 6 months prior to Screening. Subjects may be entered if they have stable hypertension or dyslipidemia on therapy. Subjects with other conditions except as noted in the Exclusion criteria may be included only if the investigator and GSK medical monitor agree that the condition is unlikely to introduce additional risk factors and will not interfere with study procedures
HbA1c levels greater than or equal to 7.0 % and less than or equal to 9.5% at Screening
On monotherapy with metformin at the time of screening, and at a maximum tolerated dose greater than or equal to 1000 mg for at least 2 months prior to dosing.
Fasting plasma glucose level less than 13.3 mmol/L (240 mg/dL) at Screening
Male or female between 20 and 70 years of age, inclusive, at the time of signing the informed consent
Fasting Triglycerides lower than 4.52 mmol/L (400 mg/dL)
A female subject is able to participate is she if of non-child bearing potential
Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 3 days after last dose of the study medication
Overweight with BMI greater than or equal to 25 kg/m2 for non-Asian Indians and greater than or equal to 24 kg/m2 for Asian-Indian, and less than 40 kg/m2
The subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Subjects in France will be eligible only if they are affiliated to or a beneficiary of a social security category
Subjects in other countries must meet all local and/or country-specific requirements for registration and reimbursement, as applicable

You may not qualify if…

Requiring insulin therapy or use of combination oral antidiabetic medications or use of monotherapy other than metformin within the 3 months prior to screening
Past or present disease (other than type 2 diabetes mellitus) that in the opinion of the Investigator may affect the outcome of this study
A positive pre-study Hepatitis B surface antigen, or positive Hepatitis C result within 3 months of screening
Renal impairment as defined by a calculated GFR less than 60 mL/min
Any concurrent serious illness (e.g., severe COPD, history of malignancy other than skin cancer within 5 years of initial diagnosis or with evidence of recurrence) that may interfere with a subject completing the study
Laboratory values as defined per protocol
ECG criteria as defined per protocol
Systolic blood pressure greater than 160 mmHg, or diastolic blood pressure greater than 100 mmHg at Screening
History of uric acid kidney stone, and being treated with drugs for hyperuricemia including Allopurinol or Probenecid
History of peptic ulcer disease (PUD) and/or other gastrointestinal bleeding within the 12 months prior to screening
Use of certain blood pressure medications or certain other medications that are renally excreted as defined per protocol
History of myopathy or CPK value greater than 3 times upper limit of normal at screening
The subject has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives or twice the biological effect (whichever is longer)
Exposure to more than four new chemical entities within 12 months prior to the first dosing day
Any change in diet, exercise habits or smoking status within six weeks prior to screening. Any subject that cannot refrain from smoking while in the unit must be excluded
History of sensitivity to any of the study medications, including sitagliptin or metformin, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation
The subject has a positive pre-study drug screen
History of regular alcohol consumption within 6 months of the study as defined per protocol
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
Pregnant females as determined by positive serum and/or urine hCG test at screening and prior to dosing
Lactating females
Subjects who are unwilling or unable to follow the procedures outlined in the protocol
Subject is mentally or legally incapacitated

Where it is running

GSK Investigational Site — Anniston, Alabama, United States
GSK Investigational Site — Miami, Florida, United States
GSK Investigational Site — Miramar, Florida, United States
GSK Investigational Site — Nantes, France
GSK Investigational Site — Pierre-Bénite, France
GSK Investigational Site — Rennes, France
GSK Investigational Site — Rueil-Malmaison, France
GSK Investigational Site — Alicante, Spain
GSK Investigational Site — Badalona, Spain
GSK Investigational Site — Granada, Spain
GSK Investigational Site — Madrid, Spain
GSK Investigational Site — Edinburgh, Midlothian, United Kingdom
GSK Investigational Site — Cambridge, United Kingdom
GSK Investigational Site — Coventry, United Kingdom
GSK Investigational Site — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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