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

Wellstat Therapeutics

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: PN2034

Drug: Insulin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00110864

PN2034.05.002

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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