Type 2 Diabetes MellitusPhase 2NCT00760578

A Placebo Controlled Safety and Efficacy Study of MSDC-0160 in Type 2 Diabetes With Active Comparator

A Phase 2 study testing Pioglitazone, MSDC-0160 90 mg and MSDC-0160 220 mg in people with Type 2 Diabetes Mellitus, run by Metabolic Solutions Development Company at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if MSDC-0160 is effective in the treatment of Type 2 diabetes. 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?: Pioglitazone, MSDC-0160 90 mg and MSDC-0160 220 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 86 participants
Where: 8 sitesUnited States
Study dates: Sep 2008to Feb 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Diagnosis of Type 2 Diabetes naive or on metformin
Male and female (postmenopausal or surgically sterilized), 18 to 70 years of age.

Who cannot join

Use of diabetes medications other than metformin.
History of heart failure or previous myocardial infarction.
Blood pressure great than 160/100 mmHg.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Study site
Dallas, Texas
Study site
Greenville, South Carolina
Study site
Kalamazoo, Michigan
Study site
Los Angeles, California
Study site
Miami Gardens, Florida
Study site
Renton, Washington
Study site
San Antonio, Texas
Study site
West Palm Beach, Florida

Other trials in United States

About this study

Official title: A Phase 2A, Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Two Dose Levels of Mitoglitazone™ in Type 2 Diabetic Patients

The purpose of this study is to determine if MSDC-0160 is effective in the treatment of Type 2 diabetes.

Conditions: Type 2 Diabetes Mellitus
Being tested: Placebo, Pioglitazone, MSDC-0160 90 mg, MSDC-0160 220 mg
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.

PlaceboDrug
Once daily, oral
PioglitazoneDrug
Once daily, oral
MSDC-0160 90 mgDrug
Once daily, oral
MSDC-0160 220 mgDrug
Once daily, oral

Study groups in NCT00760578
Study group	Role	What they receive
Placebo	Placebo comparator	Microcrystaline cellulose once daily Receives: Drug: Placebo
Pioglitazone	Active comparator	Pioglitazone 45 mg once daily Receives: Drug: Pioglitazone
MSDC-0160 90 mg	Experimental	MSDC-0160 90 mg once daily Receives: Drug: MSDC-0160 90 mg
MSDC-0160 220 mg	Experimental	MSDC-0160 220 mg once daily Receives: Drug: MSDC-0160 220 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test
Change from baseline of averaged postprandial glucose (mmol/L) in response to a Mixed-meal tolerance (MMT) test.
Measured: 28 days

Secondary outcomes (4)

Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test
Change from baseline in averaged post prandial insulin levels in response to a mixed-meal tolerance test.
Measured: After four weeks of active therapy
Change From Baseline in FFAs
Change from baseline in Free Fatty Acids (FFAs)following 28 days of active therapy, as part of a lipid profile assessment
Measured: After 28 days of active therapy
Change From Baseline in Triglycerides
Change compared to baseline in triglycerides following 28 days of active therapy, as part of a lipid profile assessment
Measured: 28 days
Change From Baseline in HDL
Change from baseline in HDL following 28 days of active therapy, as part of a lipid profile assessment
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Feb 2009

First posted26 Sep 2008 (estimated)
Study startSep 2008
Primary completionJan 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00760578
Sponsor's protocol ID: MSDC-C003
Status last verified: Mar 2013
First submitted: 25 Sep 2008
Last updated: 3 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2A, Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Two Dose Levels of Mitoglitazone™ in Type 2 Diabetic Patients
ClinicalTrials.gov ID: NCT00760578
Acronym / sponsor ID: MSDC-C003
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Metabolic Solutions Development CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Jan 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 26 Sep 2008 (estimated)
Results: Posted 3 May 2013

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 determine if MSDC-0160 is effective in the treatment of Type 2 diabetes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboMicrocrystaline cellulose once daily
Pioglitazone	Active comparator	Drug: PioglitazonePioglitazone 45 mg once daily
MSDC-0160 90 mg	Experimental	Drug: MSDC-0160 90 mgMSDC-0160 90 mg once daily
MSDC-0160 220 mg	Experimental	Drug: MSDC-0160 220 mgMSDC-0160 220 mg once daily

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of Type 2 Diabetes naive or on metformin
Male and female (postmenopausal or surgically sterilized), 18 to 70 years of age.

Key exclusion criteria (3 listed)

Use of diabetes medications other than metformin.
History of heart failure or previous myocardial infarction.
Blood pressure great than 160/100 mmHg.

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
PlaceboOnce daily, oral	Drug	Placebo
PioglitazoneOnce daily, oral	Drug	Pioglitazone
MSDC-0160 90 mgOnce daily, oral	Drug	MSDC-0160 90 mg
MSDC-0160 220 mgOnce daily, oral	Drug	MSDC-0160 220 mg

Primary outcome

Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test
Time frame: 28 days
Change from baseline of averaged postprandial glucose (mmol/L) in response to a Mixed-meal tolerance (MMT) test.

4 secondary outcomes

Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test
Time frame: After four weeks of active therapy
Change From Baseline in FFAs
Time frame: After 28 days of active therapy
Change From Baseline in Triglycerides
Time frame: 28 days
Change From Baseline in HDL
Time frame: 28 days

Results and safety

Results posted to the registry on 3 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MSDC-0160 90 mg	22	19
MSDC-0160 220 mg	21	19
Pioglitazone	21	16
Placebo	22	18

Primary outcome: Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test

Time frame: 28 days. Least squares mean (Standard Error). Unit: mmol/L

Measure	Mitoglitazone 90 mg n = 20	Mitoglitazone 220 mg n = 19	Pioglitazone 45 mg n = 16	Placebo n = 21
Value	0.16 (0.349)	-0.44 (0.358)	-1.10 (0.390)	0.51 (0.340)

Population analysed: All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MSDC-0160 90 mg	0 of 22 (0%)	4 of 22 (18.2%)	Not reported
Placebo	0 of 22 (0%)	3 of 22 (13.6%)	Not reported
Pioglitazone	0 of 21 (0%)	2 of 21 (9.5%)	Not reported
MSDC-0160 220 mg	0 of 21 (0%)	2 of 21 (9.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Jerry R Colca, PhD study director

Metabolic Solutions Development Company

8 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 Pioglitazone, MSDC-0160 90 mg and MSDC-0160 220 mg in people with Type 2 Diabetes Mellitus, run by Metabolic Solutions Development Company at 8 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 2 inclusion and 3 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 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

Yes. Results are posted in the registry (first posted 3 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00760578.

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 May 2013.