Effects of PN2034 in Insulin-Dependent Patients With Type 2 Diabetes
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Effects of PN2034 in Insulin-Dependent Patients With Type 2 Diabetes
1 other identifier
interventional
90
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes-mellitus
Started May 2005
Typical duration for phase_2 type-2-diabetes-mellitus
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 13, 2005
CompletedFirst Posted
Study publicly available on registry
May 16, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedAugust 23, 2007
August 1, 2007
May 13, 2005
August 21, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety
Effect on change in average daily insulin dose
Secondary Outcomes (3)
Effect on HbA1c levels
Effect on FPG levels
Effect on lipid levels
Interventions
Eligibility Criteria
You may qualify if:
- diagnosed with type 2 diabetes mellitus
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Phoenix Internal Medicine Associates
Waterbury, Connecticut, 06708, United States
Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021, United States
Genesis Research International
Longwood, Florida, 32779, United States
Baptist Diabetes Associates
Miami, Florida, 33156, United States
Andres Patron, DO PA
Pembroke Pines, Florida, 33028, United States
CLIRECO,Inc.
Tamarac, Florida, 33321, United States
Endocrine Clinical Research
Winter Park, Florida, 32789, United States
PRN of Kansas
Wichita, Kansas, 67203, United States
Medical Research Associates of Charlotte
Charlotte, North Carolina, 28211, United States
Neem Research Group of Charlotte
Charlotte, North Carolina, 28262, United States
Unifour Medical Research Associates
Hickory, North Carolina, 28601, United States
Neem Research Group of Raleigh
Raleigh, North Carolina, 27609, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504, United States
Camp Hill Clinical Research Center
Camp Hill, Pennsylvania, 17011, United States
Neem Research Group
Columbia, South Carolina, 29201, United States
Oaks Medical Center
Spring, Texas, 77386, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 13, 2005
First Posted
May 16, 2005
Study Start
May 1, 2005
Study Completion
April 1, 2007
Last Updated
August 23, 2007
Record last verified: 2007-08