Clinical trial NCT00110851: Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes, type 2
Lead sponsor: Wellstat Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-05-16
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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 \</=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

Primary outcomes:
measure: Safety
measure: Effect on HbA1c levels
Secondary outcomes:
measure: Effect on glucose control as measured by FPG
measure: Effect on lipid levels
Other outcomes:
Locations:
city: Waterbury
country: United States
facility: Phoenix Internal Medicine Associates
state: Connecticut
city: DeLand
country: United States
facility: University Clinical Research-DeLand
state: Florida
city: Hollywood
country: United States
facility: Center for Diabetes and Endocrine Care
state: Florida
city: Longwood
country: United States
facility: Genesis Research International
state: Florida
city: Miami
country: United States
facility: Baptist Diabetes Associates
state: Florida
city: Pembroke Pines
country: United States
facility: Andres Patron, DO PA
state: Florida
city: Tamarac
country: United States
facility: CLIRECO, Inc.
state: Florida
city: Winter Park
country: United States
facility: Endocrine Clinical Research
state: Florida
city: Wichita
country: United States
facility: PRN of Kansas
state: Kansas
city: Charlotte
country: United States
facility: Medical Research Associates of Charlotte
state: North Carolina
city: Charlotte
country: United States
facility: Neem Research Group of Charlotte
state: North Carolina
city: Hickory
country: United States
facility: Unifour Medical Research Associates
state: North Carolina
city: Raleigh
country: United States
facility: Neem Research Group of Raleigh
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Oklahoma City
country: United States
facility: COR Clinical Research, LLC
state: Oklahoma
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, PC
state: Oregon
city: Camp Hill
country: United States
facility: Camp Hill Clinical Research Center
state: Pennsylvania
city: Columbia
country: United States
facility: Neem Research Group
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Palmetto Medical Research Associates
state: South Carolina
city: Spring
country: United States
facility: Oaks Medical Center
state: Texas
Study officials:
References: