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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110851
• Other study ID #: PN2034.05.001
• Status: Completed
• Phase: Phase 2
• First received: May 13, 2005
• Last updated: August 21, 2007
• Start date: April 2005
• Est. completion date: August 2007

Study information

• Verified date: August 2007
• Source: Wellstat Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 72 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• rosiglitazone

• metformin

• PN2034

Locations

Country	Name	City	State
United States	Camp Hill Clinical Research Center	Camp Hill	Pennsylvania
United States	Medical Research Associates of Charlotte	Charlotte	North Carolina
United States	Neem Research Group of Charlotte	Charlotte	North Carolina
United States	Neem Research Group	Columbia	South Carolina
United States	University Clinical Research-DeLand	DeLand	Florida
United States	Unifour Medical Research Associates	Hickory	North Carolina
United States	Center for Diabetes and Endocrine Care	Hollywood	Florida
United States	Genesis Research International	Longwood	Florida
United States	Clinical Research Institute of Southern Oregon, PC	Medford	Oregon
United States	Baptist Diabetes Associates	Miami	Florida
United States	Palmetto Medical Research Associates	Mt. Pleasant	South Carolina
United States	COR Clinical Research, LLC	Oklahoma City	Oklahoma
United States	Andres Patron, DO PA	Pembroke Pines	Florida
United States	Neem Research Group of Raleigh	Raleigh	North Carolina
United States	Oaks Medical Center	Spring	Texas
United States	CLIRECO, Inc.	Tamarac	Florida
United States	Phoenix Internal Medicine Associates	Waterbury	Connecticut
United States	PRN of Kansas	Wichita	Kansas
United States	Piedmont Medical Research Associates	Winston-Salem	North Carolina
United States	Endocrine Clinical Research	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Wellstat Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Primary	Effect on HbA1c levels
Secondary	Effect on glucose control as measured by FPG
Secondary	Effect on lipid levels