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

This study has been completed.
Sponsor:
Information provided by:
Wellstat Therapeutics
ClinicalTrials.gov Identifier:
NCT00110864
First received: May 13, 2005
Last updated: August 21, 2007
Last verified: August 2007
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: PN2034
Drug: Insulin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Effects of PN2034 in Insulin-Dependent Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Wellstat Therapeutics:

Primary Outcome Measures:
  • Safety
  • Effect on change in average daily insulin dose

Secondary Outcome Measures:
  • Effect on HbA1c levels
  • Effect on FPG levels
  • Effect on lipid levels

Estimated Enrollment: 90
Study Start Date: May 2005
Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110864

Locations
United States, Connecticut
Phoenix Internal Medicine Associates
Waterbury, Connecticut, United States, 06708
United States, Florida
Center for Diabetes and Endocrine Care
Hollywood, Florida, United States, 33021
Genesis Research International
Longwood, Florida, United States, 32779
Baptist Diabetes Associates
Miami, Florida, United States, 33156
Andres Patron, DO PA
Pembroke Pines, Florida, United States, 33028
CLIRECO,Inc.
Tamarac, Florida, United States, 33321
Endocrine Clinical Research
Winter Park, Florida, United States, 32789
United States, Kansas
PRN of Kansas
Wichita, Kansas, United States, 67203
United States, North Carolina
Medical Research Associates of Charlotte
Charlotte, North Carolina, United States, 28211
Neem Research Group of Charlotte
Charlotte, North Carolina, United States, 28262
Unifour Medical Research Associates
Hickory, North Carolina, United States, 28601
Neem Research Group of Raleigh
Raleigh, North Carolina, United States, 27609
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
COR Clinical Research, LLC
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States, 97504
United States, Pennsylvania
Camp Hill Clinical Research Center
Camp Hill, Pennsylvania, United States, 17011
United States, South Carolina
Neem Research Group
Columbia, South Carolina, United States, 29201
United States, Texas
Oaks Medical Center
Spring, Texas, United States, 77386
Sponsors and Collaborators
Wellstat Therapeutics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00110864     History of Changes
Other Study ID Numbers: PN2034.05.002
Study First Received: May 13, 2005
Last Updated: August 21, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Wellstat Therapeutics:
diabetes, type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014