Type 2 Diabetes MellitusPhase 2NCT00458016
Safety, Tolerability, and Efficacy Study of MB07803 Administered to Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing MB07803 in people with Type 2 Diabetes Mellitus, run by Ligand Pharmaceuticals at 25 sites in United States.
Trial summary
The purpose of this study is to collect important information regarding the safety, tolerability, and efficacy of MB07803 when administered for 28 days in patients with type 2 diabetes mellitus Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- MB07803
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 25 sitesUnited States
- Study dates
- Mar 2007to Mar 2008
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting plasma glucose between 120 - 270 mg/dL at screening
- HbA1c measurements between 6.0 - 10% at screening
- Females who are surgically sterile (i.e. women who have had a hysterectomy or tubal ligation). Females who are postmenopausal for at least 12 consecutive months and documented by blood follicular stimulating hormone (FSH) greater than or equal to 40 mlU/mL.Females of childbearing potential must be willing to use an approved double-barrier method of birth control (e.g. condom plus spermicide ;IUD plus spermicide) from the time of signing the informed consent form through 4 weeks following the last dose of study drug.
- Body mass index (BMI) in the range of 18.5 - 37 kg/m2 Patients with a BMI in the range of 37.5 - 40 kg/m2 who in the Investigator's opinion, are in good health and satisfy the eligibility criteria, will be considered on a case-by case basis
- Written informed consent
Who cannot join
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus with a history of diabetic ketoacidosis or ketosis-prone
- Use of thiazolidinediones (TZDs)
- Currently on more than two oral hypoglycemic agent
- History of outpatient insulin use
- Clinically significant history of cardiac disease within 6 months of informed consent
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Study site
Bristol, Tennessee, 37620
Study site
Butte, Montana, 59701
Study site
Charleston, South Carolina, 29407
Study site
Charlotte, North Carolina, 28209
Study site
Chicago, Illinois, 60607
Study site
Chicago, Illinois, 60611
Study site
Cincinnati, Ohio, 45246
Study site
Corpus Christi, Texas, 78404
Study site
Dallas, Texas, 75231
Study site
Delaware, Ohio, 43015
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46254
Study site
Indianapolis, Indiana, 46260
Study site
Las Vegas, Nevada, 89123
Study site
Los Angeles, California, 90057
Study site
Marion, Ohio, 43302
Study site
Miami, Florida, 33169
Study site
Miami Gardens, Florida, 33169
Study site
Richmond, Virginia, 23249
Study site
San Antonio, Texas, 78229
Study site
Statesville, North Carolina, 28677
Study site
Tulsa, Oklahoma, 74104
Study site
Walnut Creek, California, 94598
Study site
Willoughby Hills, Ohio, 44094
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2, 28-day, Multicenter, Double-Blind,Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability and Efficacy of MB07803 in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to collect important information regarding the safety, tolerability, and efficacy of MB07803 when administered for 28 days in patients with type 2 diabetes mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- MB07803, Placebo
- 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.
MB07803Drug
Daily oral administration
PlaceboDrug
Daily oral administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: MB07803 |
| 2 | Experimental | Not described Receives: Drug: MB07803 |
| 3 | Experimental | Not described Receives: Drug: MB07803 |
| 4 | Experimental | Not described Receives: Drug: MB07803 |
| 5 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Plasma Glucose Concentration
Measured: Change from baseline to Day 28
Secondary outcomes (1)
Fasting serum triglycerides and free fatty acids, fasting serum insulin.
Measured: Change from baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2008
- Study completionMar 2008
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ligand Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458016
- Sponsor's protocol ID
- MB07803-202
- Status last verified
- Sep 2011
- First submitted
- 5 Apr 2007
- Last updated
- 3 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, 28-day, Multicenter, Double-Blind,Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability and Efficacy of MB07803 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00458016
- Acronym / sponsor ID
- MB07803-202
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Ligand PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 9 Apr 2007 (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.
The purpose of this study is to collect important information regarding the safety, tolerability, and efficacy of MB07803 when administered for 28 days in patients with type 2 diabetes mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MB07803 |
| 2 | Experimental | Drug: MB07803 |
| 3 | Experimental | Drug: MB07803 |
| 4 | Experimental | Drug: MB07803 |
| 5 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fasting plasma glucose between 120 - 270 mg/dL at screening
- HbA1c measurements between 6.0 - 10% at screening
- Females who are surgically sterile (i.e. women who have had a hysterectomy or tubal ligation). Females who are postmenopausal for at least 12 consecutive months and documented by blood follicular stimulating hormone (FSH) greater than or equal to 40 mlU/mL.Females of childbearing potential must be willing to use an approved double-barrier method of birth control (e.g. condom plus spermicide ;IUD plus spermicide) from the time of signing the informed consent form through 4 weeks following the last dose of study drug.
- Body mass index (BMI) in the range of 18.5 - 37 kg/m2 Patients with a BMI in the range of 37.5 - 40 kg/m2 who in the Investigator's opinion, are in good health and satisfy the eligibility criteria, will be considered on a case-by case basis
- Written informed consent
Key exclusion criteria (6 listed)
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus with a history of diabetic ketoacidosis or ketosis-prone
- Use of thiazolidinediones (TZDs)
- Currently on more than two oral hypoglycemic agent
- History of outpatient insulin use
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 |
|---|---|---|
| MB07803Daily oral administration | Drug | 1, 2, 3, 4 |
| PlaceboDaily oral administration | Drug | 5 |
Primary outcome
Fasting Plasma Glucose Concentration
Time frame: Change from baseline to Day 28
1 secondary outcome
Fasting serum triglycerides and free fatty acids, fasting serum insulin.
Time frame: Change from baseline to Day 28
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 3 Oct 2011.
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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.
25 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 MB07803 in people with Type 2 Diabetes Mellitus, run by Ligand Pharmaceuticals at 25 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 5 inclusion and 6 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 3 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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. Some participants in this study may receive a placebo. 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?
Fasting Plasma Glucose Concentration (time frame: Change from baseline to Day 28). 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 3 Oct 2011.