Type 2 Diabetes MellitusPhase 2NCT00110851
Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)
A Phase 2 study testing rosiglitazone, metformin and PN2034 in people with Type 2 Diabetes Mellitus, run by Wellstat Therapeutics at 20 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 72 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- rosiglitazone, metformin and PN2034
- How many people
- 90 participants
- Where
- 20 sitesUnited States
- Study dates
- Apr 2005to Aug 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Camp Hill Clinical Research Center
Camp Hill, Pennsylvania, 17011
Medical Research Associates of Charlotte
Charlotte, North Carolina, 28211
Neem Research Group of Charlotte
Charlotte, North Carolina, 28262
Neem Research Group
Columbia, South Carolina, 29201
University Clinical Research-DeLand
DeLand, Florida, 32720
Unifour Medical Research Associates
Hickory, North Carolina, 28601
Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021
Genesis Research International
Longwood, Florida, 32779
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504
Baptist Diabetes Associates
Miami, Florida, 33156
Palmetto Medical Research Associates
Mt. Pleasant, South Carolina, 29464
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103
Andres Patron, DO PA
Pembroke Pines, Florida, 33028
Neem Research Group of Raleigh
Raleigh, North Carolina, 27609
Oaks Medical Center
Spring, Texas, 77386
CLIRECO, Inc.
Tamarac, Florida, 33321
Phoenix Internal Medicine Associates
Waterbury, Connecticut, 06708
PRN of Kansas
Wichita, Kansas, 67203
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
Endocrine Clinical Research
Winter Park, Florida, 32789,
About this study
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
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).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- rosiglitazone, metformin, PN2034
- Keywords
- diabetes, type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazoneDrug
metforminDrug
PN2034Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Effect on HbA1c levels
Secondary outcomes (2)
Effect on glucose control as measured by FPG
Effect on lipid levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2005 (estimated)
- Study startApr 2005
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wellstat Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110851
- Sponsor's protocol ID
- PN2034.05.001
- Status last verified
- Aug 2007
- First submitted
- 13 May 2005
- Last updated
- 23 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00110851
- Acronym / sponsor ID
- PN2034.05.001
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Wellstat TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Aug 2007 (actual)
- First posted
- 16 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosiglitazone | Drug | – |
| metformin | Drug | – |
| PN2034 | Drug | – |
Primary outcome
Safety
Effect on HbA1c levels
2 secondary outcomes
Effect on glucose control as measured by FPG
Effect on lipid levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rosiglitazone, metformin and PN2034 in people with Type 2 Diabetes Mellitus, run by Wellstat Therapeutics at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2007.