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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PN2034
Insulin
Sponsored by
Wellstat Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, type 2

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix Internal Medicine Associates
  • Center for Diabetes and Endocrine Care
  • Genesis Research International
  • Baptist Diabetes Associates
  • Andres Patron, DO PA
  • CLIRECO,Inc.
  • Endocrine Clinical Research
  • PRN of Kansas
  • Medical Research Associates of Charlotte
  • Neem Research Group of Charlotte
  • Unifour Medical Research Associates
  • Neem Research Group of Raleigh
  • Piedmont Medical Research Associates
  • COR Clinical Research, LLC
  • Clinical Research Institute of Southern Oregon, PC
  • Camp Hill Clinical Research Center
  • Neem Research Group
  • Oaks Medical Center

Outcomes

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

Full Information

First Posted
May 13, 2005
Last Updated
August 21, 2007
Sponsor
Wellstat Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00110864
Brief Title
Effects of PN2034 in Insulin-Dependent Patients With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wellstat Therapeutics

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes, type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PN2034
Intervention Type
Drug
Intervention Name(s)
Insulin
Primary Outcome Measure Information:
Title
Safety
Title
Effect on change in average daily insulin dose
Secondary Outcome Measure Information:
Title
Effect on HbA1c levels
Title
Effect on FPG levels
Title
Effect on lipid levels

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Phoenix Internal Medicine Associates
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Center for Diabetes and Endocrine Care
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Genesis Research International
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Baptist Diabetes Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Andres Patron, DO PA
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
CLIRECO,Inc.
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Endocrine Clinical Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
PRN of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Medical Research Associates of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Neem Research Group of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
Unifour Medical Research Associates
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Neem Research Group of Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Piedmont Medical Research Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
COR Clinical Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, PC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Camp Hill Clinical Research Center
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Neem Research Group
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Oaks Medical Center
City
Spring
State/Province
Texas
ZIP/Postal Code
77386
Country
United States

12. IPD Sharing Statement

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

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