Study In People With Type 2 Diabetes

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 2

In brief

This Phase 2 dose-ranging study will evaluate the efficacy, safety and tolerability of a range of doses of GW677954 compared with placebo over sixteen weeks of treatment in subjects with T2DM (Type 2 Diabetes Mellitus).

Key facts

Study ID

NCT00196989

Run by

GlaxoSmithKline

People needed

448

Starts

2005-09-01

Expected to finish

2007-04-01

Last updated by the study team

2017-03-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with T2DM as defined by the criteria of the ADA and/or recognized by WHO Expert Committee on the Diagnosis and Classification of Diabetes Mellitus [American Diabetes Association, 2004], for at least 3 months preceding screening (see Section 15.3, Appendix 3:, "Diagnosis and Classification of Diabetes Mellitus").
• To be eligible for Randomization into the trial, a subject must satisfy all of the following glycemic criteria:
• HbA1c level via central laboratory at the pre-screening visit
• If HbA1c ≥ 8.0% but ≤ 10.0%: subject may proceed to Randomization;
• If HbA1c ≥ 7.8% but < 8.0%, subject not eligible to proceed, but may be retested once to establish eligibility (or lack thereof). If HbA1c level ≥ 8.0% upon retest, subject is eligible to proceed; otherwise they should be withdrawn.
• If HbA1c < 7.8%, subject not eligible to proceed (no retest allowed).
• FPG level via central laboratory at the pre-screening visit must be < 270 mg/dL (15.0 mmol/L). FPG may be retested within a week to confirm eligibility (or lack thereof).
• Concurrent T2DM therapy:
• Diet and/or exercise treated: Must not have taken antidiabetic medication for at least 2 months prior to the pre-screening visit, OR
• Metformin monotherapy: Subjects entering the study on metformin must be on the same dose, formulation and regimen of metformin for at least 2 months prior to the pre-screening visit, AND
• TZDs and insulin are excluded in the 3 months prior to the Screening visit for all subjects.
• Males and females who are 18 to 70 years of age inclusive at the time of Screening.
• If female, eligible to enter and participate in this study:
• If of non-childbearing potential (i.e., physiologically incapable of becoming pregnant (tubal ligation), including any female who is post-menopausal [>1 year without menstrual period]); or,
• If of child-bearing potential, has a negative pregnancy test at Screening (serum), at Randomization (urine) and:
• Has a male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or
• Uses double-barrier methods of contraception; condoms with the use of caps (with spermicide) and IUDs are acceptable, or
• Uses hormonal contraceptives (oral, depots, patches etc) with double- barrier methods of contraception as outlined above, or
• Abstains from sexual intercourse, or
• Is with a same sex partner and does not participate in bisexual activities where there is any risk of pregnancy.
• Body Mass Index (BMI): ≥25 and ≤40 kg/m² and weigh at least 50 kg at Screening.
• If subject is a smoker, must be able to abstain while in clinic at each visit.
• Subject has given full written informed consent prior to any study related procedures are performed.

You may not qualify if…

• Exclusion Criteria:
• Metabolic Disease including:
• Diagnosis of Type 1 diabetes mellitus
• Uncorrected thyroid dysfunction. (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least 1 month prior to Screening, and who have a screening thyroid stimulating hormone (TSH) within the upper limit of normal may participate).
• Significant weight gain or loss (defined as > 5% of total body weight) within the 3 months prior to Screening.
• Previous use of insulin for treatment of hyperglycemia within 3 months of Screening.
• History of recent clinically significant cardiovascular disease including:
• History or ECG evidence of prior myocardial infarction within 6 months prior to Screening.
• Current unstable angina or history of unstable angina in past 6 months.
• Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery that is either planned or occurred in the 6 months prior to Screening.
• Clinically significant arrhythmia or valvular heart disease.
• Congestive heart failure (CHF) with New York Heart Association (NYHA) Class II-IV symptoms (see Section 15.4, Appendix 4).
• Blood pressure > 160/100 mmHg or resting heart rate > 100 bpm. Note: subjects using antihypertensives [e.g., beta blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin II antagonists, calcium channel blockers and diuretics] must be on stable doses during the 30 days prior to Screening and during the trial.
• Has a QTc interval (Bazett's) > 440 msec in males and > 450 msec in females at Screening.
• Clinically significant ECG abnormalities which, in the opinion of the Investigator, may affect the interpretation of safety data, or which otherwise, contraindicates participation in a clinical trial with a new chemical entity.
• History of chronic pancreatitis.
• Familial hypercholesterolemia.
• TGs ≥800 mg/dL (8.96 mmol/L) at Screening.
• Serum creatinine at screening > 1.4 mg/dL (124 µmol/L) for women, or > 1.5 mg/dL (133 µmol/L) for men.
• Clinically significant anemia defined by hemoglobin concentrations <12.0 g/dL or < 120.0 g/L for males and < 11.0 g/dL or < 110.0 g/L for females.
• History of significant co-morbid diseases (e.g., cholelithiasis, gastrointestinal disease, etc.) that would preclude participation in the study.
• Documented history of hepato-biliary disease including a history of, or positive laboratory results for hepatitis (hepatitis B surface antigen and/or hepatitis C antibody) at Screening, and/or clinically significant hepatic enzyme elevation including:
• Any one of the following enzymes greater than 2.5 times the upper limit of normal (ULN) value at Screening:
• Alanine aminotransferase (ALT)
• Aspartate aminotransferase (AST)

Where it is running

• GSK Investigational Site — Northport, Alabama, United States
• GSK Investigational Site — Chandler, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Alhambra, California, United States
• GSK Investigational Site — Artesia, California, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Inglewood, California, United States
• GSK Investigational Site — Irvine, California, United States
• GSK Investigational Site — La Jolla, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Northridge, California, United States
• GSK Investigational Site — Norwalk, California, United States
• GSK Investigational Site — Pasadena, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Santa Monica, California, United States
• GSK Investigational Site — Tustin, California, United States
• GSK Investigational Site — Vista, California, United States
• GSK Investigational Site — West Hills, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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