Effects of PN2034 in Insulin-Dependent Patients With Type 2 Diabetes

Completed · Phase 2

Conditions studied: Type 2 Diabetes Mellitus

In brief

This study is designed to evaluate the safety and efficacy of PN2034 in insulin-dependent type 2 diabetics as measured by the change in average daily insulin dose from baseline to week 12. The effects of PN2034 on HbA1c, fasting plasma glucose (FPG), and lipid levels will also be measured.

Key facts

Study ID

NCT00110864

Run by

Wellstat Therapeutics

People needed

90

Starts

2005-05-01

Expected to finish

2007-04-01

Last updated by the study team

2007-08-23

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Phoenix Internal Medicine Associates — Waterbury, Connecticut, United States
• Center for Diabetes and Endocrine Care — Hollywood, Florida, United States
• Genesis Research International — Longwood, Florida, United States
• Baptist Diabetes Associates — Miami, Florida, United States
• Andres Patron, DO PA — Pembroke Pines, Florida, United States
• CLIRECO,Inc. — Tamarac, Florida, United States
• Endocrine Clinical Research — Winter Park, Florida, United States
• PRN of Kansas — Wichita, Kansas, United States
• Medical Research Associates of Charlotte — Charlotte, North Carolina, United States
• Neem Research Group of Charlotte — Charlotte, North Carolina, United States
• Unifour Medical Research Associates — Hickory, North Carolina, United States
• Neem Research Group of Raleigh — Raleigh, North Carolina, United States
• Piedmont Medical Research Associates — Winston-Salem, North Carolina, United States
• COR Clinical Research, LLC — Oklahoma City, Oklahoma, United States
• Clinical Research Institute of Southern Oregon, PC — Medford, Oregon, United States
• Camp Hill Clinical Research Center — Camp Hill, Pennsylvania, United States
• Neem Research Group — Columbia, South Carolina, United States
• Oaks Medical Center — Spring, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.