None listed
Conditions
Brief summary
Not mandatory
Interventions
This study will test a 4-week treatment course of the investigational drug, PHX1149, at doses of 100mg, 200mg or 400mg, orally once daily, in patients with Type 2 diabetes mellitus.
Sponsors
Phenomix Corporation, USA
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Body mass index (BMI) 25 to 40 kg/m2, inclusive; Type 2 diabetes mellitus; current treatment of Type 2 diabetes mellitus = 1500 mg/day of metformin or highest tolerated dose for at least 4 weeks prior to Screening visit; fasting plasma glucose of 118 – 220 mg/dL, inclusive; HbA1c (which reflects average blood glucose level over the past 2-3 months) 7.5% - 9.5%, inclusive; and a fasting plasma C-peptide greater than 0.26 nmol/L at screening; no Type 1 diabetes mellitus or marked diabetic long-term complications.
Exclusion criteria
MODY (Mature Onset Diabetes of the Young), insulin dependent type 2 diabetes mellitus, or other unusual or rare forms of diabetes Mellitus; epilepsy; history of diabetic coma or severe hypoglycemic episode during the 6 months prior to screening; history of stroke, myocardial infarction, symptomatic coronary artery disease, angina, congestive heart failure, or arrhythmia during the 12 months prior to screening; inadequately controlled hypertension; gastrointestinal surgery for obesity; current efforts to lose weight; current administration of anti-psychotic medications, products intended to stimulate appetite, central stimulants, androgens, or growth hormone; administration within the past 2 weeks of systemic glucocorticoids; uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, immunosuppressive, psychiatric, or urogenital disorder; diseases of the skin and its appendages, the eyes, ears, nose, or throat; malignancy within the past 5 years; HIV, Hepatitis B, or Hepatitis C; history of alcohol or substance abuse in the past 2 years or an eating disorder in the past 5 years; use of any investigational drug or participation in any investigational study within 30 days prior to screening; relevant laboratory abnormalities.
Outcome results
None listed