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

August 21, 2007 updated by: Wellstat Therapeutics

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Effects of PN2034 in Insulin-Dependent Patients With Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Effect on change in average daily insulin dose

Secondary Outcome Measures

Outcome Measure
Effect on HbA1c levels
Effect on lipid levels
Effect on FPG levels

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wellstat Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

May 13, 2005

First Submitted That Met QC Criteria

May 13, 2005

First Posted (Estimate)

May 16, 2005

Study Record Updates

Last Update Posted (Estimate)

August 23, 2007

Last Update Submitted That Met QC Criteria

August 21, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PN2034.05.002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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