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

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: rosiglitazone (Drug); metformin (Drug); PN2034 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Wellstat Therapeutics

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).

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Effects of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet) Therapy

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Safety

Effect on HbA1c levels

Secondary outcome:

Effect on glucose control as measured by FPG

Effect on lipid levels

Minimum age: 21 Years. Maximum age: 72 Years. Gender(s): Both.

Criteria:

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

- fasting blood sugar level >/= 125 mg/dL but

- 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)

- 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

Phoenix Internal Medicine Associates, Waterbury, Connecticut 06708, United States

CLIRECO, Inc., Tamarac, Florida 33321, United States

University Clinical Research-DeLand, DeLand, Florida 32720, United States

Endocrine Clinical Research, Winter Park, Florida 32789,, United States

Genesis Research International, Longwood, Florida 32779, United States

Baptist Diabetes Associates, Miami, Florida 33156, United States

Center for Diabetes and Endocrine Care, Hollywood, Florida 33021, United States

Andres Patron, DO PA, Pembroke Pines, Florida 33028, United States

PRN of Kansas, Wichita, Kansas 67203, United States

Piedmont Medical Research Associates, Winston-Salem, North Carolina 27103, United States

Medical Research Associates of Charlotte, Charlotte, North Carolina 28211, United States

Unifour Medical Research Associates, Hickory, North Carolina 28601, United States

Neem Research Group of Raleigh, Raleigh, North Carolina 27609, United States

Neem Research Group of Charlotte, Charlotte, North Carolina 28262, United States

COR Clinical Research, LLC, Oklahoma City, Oklahoma 73103, United States

Clinical Research Institute of Southern Oregon, PC, Medford, Oregon 97504, United States

Camp Hill Clinical Research Center, Camp Hill, Pennsylvania 17011, United States

Neem Research Group, Columbia, South Carolina 29201, United States

Palmetto Medical Research Associates, Mt. Pleasant, South Carolina 29464, United States

Oaks Medical Center, Spring, Texas 77386, United States

Starting date: April 2005
Ending date: August 2007
Last updated: August 21, 2007