Effects of PN2034 in Insulin-Dependent Patients With Type 2 Diabetes
Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, type 2
Eligibility Criteria
Inclusion Criteria: diagnosed with type 2 diabetes mellitus 21 to 65 years of age on stable doses of insulin (>/= 40 units/day) alone or with metformin for at least 3 months HbA1c level of >/=7.5% but </=10.0% fasting blood sugar level >/= 125 mg/dL but </= 279 mg/dL BMI 26-43 kg/m2 direct bilirubin < 1.5x the upper limit of normal (ULN) serum creatinine < 1.5 mg/dL (males) or < 1.4 mg/dL (females) blood urea nitrogen (BUN)</=40 mg/dL all other clinical laboratory parameters (hematology, serum chemistry, and urinalysis) within normal limits or not clinically significant ECG normal, or abnormalities not clinically significant surgically sterile,postmenopausal,or using adequate contraception and have a negative pregnancy test at Screening able to perform daily self-monitoring of blood glucose (SMBG) tests willing and able to sign an informed consent form Exclusion Criteria: diagnosed with type 1 diabetes mellitus or has a history of ketoacidosis treatment with TZDs or any other oral antidiabetic (excluding metformin) within 3 months prior to screening or during study treatment change in lipid-lowering medication within 2 months of screening taken systemic corticosteroids within 1 month prior to screening or during study treatment history of or current/active cardiovascular disease significant current pulmonary conditions significant thyroid disease CPK value > 3x ULN a female who is pregnant or lactating systolic BP > 160 mm Hg or a diastolic BP > 90 mm Hg at screening previous or current history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin, that has not been in remission within 5 years prior to randomization liver function tests (ALT, AST, ALP) > 2 times ULN, or active liver disease at screening history of positive HIV positive hepatitis B test at screening weight loss or gain >/= 15 lbs within 3 months of screening history of substance abuse (including alcohol abuse) within 2 years prior to screening donated and/or received any blood or blood products within 3 months prior to randomization taken an investigational study medication within 30 days prior to screening or during the study
Sites / Locations
- Phoenix Internal Medicine Associates
- Center for Diabetes and Endocrine Care
- Genesis Research International
- Baptist Diabetes Associates
- Andres Patron, DO PA
- CLIRECO,Inc.
- Endocrine Clinical Research
- PRN of Kansas
- Medical Research Associates of Charlotte
- Neem Research Group of Charlotte
- Unifour Medical Research Associates
- Neem Research Group of Raleigh
- Piedmont Medical Research Associates
- COR Clinical Research, LLC
- Clinical Research Institute of Southern Oregon, PC
- Camp Hill Clinical Research Center
- Neem Research Group
- Oaks Medical Center