Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)

Wellstat Therapeutics

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: PN2034

Drug: metformin

Drug: rosiglitazone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00110851

PN2034.05.001

Details and patient eligibility

About

This study is designed to evaluate the safety and efficacy of PN2034 administered to type 2 diabetics on concomitant rosiglitazone and metformin (or Avandamet) therapy as measured by change in glycosylated hemoglobin (HbA1c) levels from baseline to Week 12. Also the study will evaluate the effect of PN2034 on glucose control as measured by fasting plasma glucose (FPG) and on fasting lipid levels: triglycerides, total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), and very low-density lipoproteins (VLDL).

Enrollment

90 estimated patients

Sex

All

Ages

21 to 72 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

diagnosed with type 2 diabetes mellitus
21 to 72 years of age
taking rosiglitazone and metformin (or Avandamet) for at least 3 months, and on a stable dose of rosiglitazone (or Avandamet) for at least 2 months
glycosylated hemoglobin (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
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 insulin, TZDs (excluding rosiglitazone) or any other oral or injected antidiabetic (excluding metformin or Avandamet) 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