Status:
COMPLETED
Effects of PN2034 in Insulin-Dependent Patients With Type 2 Diabetes
Lead Sponsor:
Wellstat Therapeutics
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00110864
Start Date
May 1 2005
End Date
April 1 2007
Last Update
August 23 2007
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Phoenix Internal Medicine Associates
Waterbury, Connecticut, United States, 06708
2
Center for Diabetes and Endocrine Care
Hollywood, Florida, United States, 33021
3
Genesis Research International
Longwood, Florida, United States, 32779
4
Baptist Diabetes Associates
Miami, Florida, United States, 33156