Type 2 DiabetesPhase 2NCT01103414

Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of Mitoglitazone in Type 2 Diabetic Patients

A Phase 2 study testing Mitoglitazone and Pioglitazone in people with Type 2 Diabetes, run by Metabolic Solutions Development Company at 24 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of three dose levels of Mitoglitazone™ (MSDC-0160) in patients with type 2 diabetes. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Mitoglitazone and Pioglitazone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 356 participants
Where: 24 sitesUnited States
Study dates: Sep 2010to Dec 2011
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females with Type 2 diabetes (fasting plasma glucose ≥126 mg/dL at screening, glycosylated hemoglobin [HbA1c] >7 and ≤10%, and Insulin C-peptide >1 ng/mL). Patients can be naïve to diabetes therapy or if taking metformin should be on a stable dose level for a period of at least 3 months prior to screening visit (no dose limit).
Between the ages of 18-75 years, inclusive.
Females should be either postmenopausal (at least 12 months since last menses) or surgically sterilized (bilateral tubal ligation or hysterectomy). Menopausal status will be verified by a follicle-stimulating hormone (FSH) test. If FSH levels are below 40 mIL/mL, some method of birth control must be used. Those with bilateral tubal ligation must also use a barrier method of birth control. In addition, all females must have a negative pregnancy test at Screen and Day 15 regardless of childbearing potential. Males with female partners of child-bearing potential must agree to use adequate contraceptive methods (including a condom, plus one other form of contraception) if engaging in sexual intercourse.
Body Mass Index (BMI) = 23 kg/m2 to 45 kg/m2 (inclusive).
Willing and able to make a screening visit to the clinic and seven visits over a 21 week period.
Willing and able to sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.

Who cannot join

Use of TZDs or diabetes medications other than metformin (generic or Glucophage®) 3 months prior to screening.
History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
Fasting plasma glucose in excess of 240 mg/dl at screening
History of heart failure (including CHF) or previous cardiovascular event (myocardial infarct, by-pass surgery, or PTCA) within the past 6 months prior to screening.
ALT and/or AST levels that are twice the upper limit of normal; bilirubin levels that exceed 2 mg/dL; serum creatinine >1.5 mg/dL in men or > 1.4 mg/dL in women.
History nephropathy, neuropathy, or retinopathy within 6 months of screening.

Show all 23Show fewer

Use of glucocorticoids (oral, injectible, intraarticular, or chronic inhaled) or weight-loss drugs within 3 months of randomization.
Current or recurrent disease that may affect the action, absorption or disposition of the study treatment, or clinical or laboratory assessments.
Current or history of severe or unstable disorder (medical or psychiatric) requiring treatment that may make the patient unlikely to complete the study.
Febrile illness within the 5 days prior to the first dose.
Known history of HIV, hepatitis B, or hepatitis C.
Clinically significant findings on physical examination, including BP, pulse rate and 12-lead ECG.
Blood pressure greater than 160/100 mmHg. Patients with elevated BP (<160/100 mmHg) with or without current treatment will be allowed at the discretion of the Principal Investigator (PI) and primary care physician. Individuals with hypertension must have been stabilized to the current treatment regimen for at least 6 weeks prior to screening.
Change in BP or lipid-lowering medication within 6 weeks or change in dose of metformin or thyroid replacement within 3 months prior to screening.
Known or suspected intolerance or hypersensitivity to the study drugs, closely related compounds or any of their stated ingredients.
History of alcohol or drug abuse within 6 months of Screening.
Have participated in an investigational study or received an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
Blood donation of 1 pint or more within 56 days of screening.
Plasmapheresis or plasma donation within 30 days of screening.
Single 12-lead ECG demonstrating a QTc >450 msec at Screening. A single repeat ECG may be done at the investigator's discretion.
Any surgical or medical condition which may significantly alter the absorption of any drug substance including, but not limited to, any of the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active inflammatory bowel syndrome.
Evidence of clinically relevant pathology that could interfere with the study results or put the patient's safety at risk.
Malignancy, including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

Study site
Chicago, Illinois
Study site
Chino, California
Study site
Cincinnati, Ohio
Study site
Corpus Christi, Texas
Study site
Eugene, Oregon
Study site
Grand Rapids, Michigan
Study site
Greer, South Carolina
Study site
Houston, Texas
Study site
Huntsville, Alabama
Study site
Indianapolis, Indiana
Study site
Kettering, Ohio
Study site
Los Angeles, California
Study site
Marietta, Georgia
Study site
Miami, Florida
Study site
Muscle Shoals, Alabama
Study site
New Port Richley, Florida
Study site
Oklahoma City, Oklahoma
Study site
Palm Harbor, Florida
Study site
Pembroke Pines, Florida
Study site
Portland, Oregon
Study site
San Antonio, Texas
Study site
Spring Valley, California
Study site
Tiffin, Ohio
Study site
Walnut Creek, California

Other trials in United States

About this study

Official title: Phase 2B, Randomized, Double-Blind, Comparator- & Placebo-Controlled, Dose Ranging Study to Evaluate Safety, Tolerability & Efficacy of 3 Dose Levels of Mitoglitazone in Type 2 Diabetic Patients

The purpose of this study is to evaluate the safety, tolerability and efficacy of three dose levels of Mitoglitazone™ (MSDC-0160) in patients with type 2 diabetes.

Read the detailed description

The primary study objectives are to characterize the reduction in fasting plasma glucose in response to three different doses of Mitoglitazone as compared to placebo following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes and to investigate the safety and tolerability of three different doses of Mitoglitazone following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.

Conditions: Type 2 Diabetes
Being tested: Mitoglitazone, Pioglitazone, Placebo
Keywords: Diabetes
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MitoglitazoneDrug
Also called MSDC-0160
50 mg capsules, once daily for 84 days
MitoglitazoneDrug
Also called MSDC-0160
Mitoglitazone 100 mg capsules, once daily for 84 days
MitoglitazoneDrug
Also called MSDC-0160
Mitoglitazone 150 mg capsules, once daily for 84 days
PioglitazoneDrug
Also called ACTOS
Pioglitazone 45 mg, once daily for 84 days
PlaceboDrug
Placebo, once daily for 84 days

Study groups in NCT01103414
Study group	Role	What they receive
Mitoglitazone 50 mg capsules	Experimental	Mitoglitazone 50 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. Receives: Drug: Mitoglitazone
Mitoglitazone 100 mg capsules	Experimental	Mitoglitazone 100 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. Receives: Drug: Mitoglitazone
Mitoglitazone 150 mg capsules	Experimental	Mitoglitazone 150 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. Receives: Drug: Mitoglitazone
Pioglitazone 45 mg capsules	Active comparator	Pioglitazone 45 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. Receives: Drug: Pioglitazone
Matching placebo	Placebo comparator	Placebo capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12.
Change from baseline in fasting plasma glucose in response to three different doses of Mitoglitazone as compared to pioglitazone following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.
Measured: Baseline, Week 12

Secondary outcomes (10)

Change From Baseline in HbA1c
Change from baseline in plasma glucose measured by hemoglobin A1c in response to three different doses of Mitoglitazone and pioglitazone as compared to placebo following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.
Measured: 12 weeks
Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin
Percent change from baseline to week 12 endpoint in high molecular weight adiponectin
Measured: 12 weeks
Change From Baseline to Week 12 Endpoint in Hematocrit
Change from baseline to week 12 endpoint in hematocrit as an indication of fluid retention
Measured: 12 weeks
Change From Baseline in Hemoglobin
Change from baseline at week 12 endpoint in hemoglobin concentration
Measured: 12 weeks
Change From Baseline in RBC
Change from baseline at week 12 endpoint in red blood cell concentration
Measured: 12 week
Change in Body Weight From Baseline to Week 12 Endpoint
Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on body weight following once-daily dosing for 12
Measured: 12 weeks
Change From Baseline in Waist Circumference at Week 12 Endpoint
Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on waist circumference following once-daily dosing for 12 weeks
Measured: 12 weeks
Presence of Edema Post Baseline During 12 Weeks Active Treatment
Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on presence of edema following once-daily dosing for 12 weeks
Measured: 12 weeks
Changes in HDL Particle Size Subfractions From Baseline to Week 12
Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on HDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks
Measured: 12 weeks
Changes in LDL Particle Size Subfractions From Baseline to Week 12
Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on LDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks
Measured: 12 week

Timeline

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

Sep 2010Dec 2011

First posted14 Apr 2010 (estimated)
Study startSep 2010
Primary completionNov 2011
Study completionDec 2011

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 DiabetesStudies 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: 356 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01103414
Sponsor's protocol ID: MSDC-C004
Status last verified: Apr 2013
First submitted: 7 Apr 2010
Last updated: 28 Apr 2015
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 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2B, Randomized, Double-Blind, Comparator- & Placebo-Controlled, Dose Ranging Study to Evaluate Safety, Tolerability & Efficacy of 3 Dose Levels of Mitoglitazone in Type 2 Diabetic Patients
ClinicalTrials.gov ID: NCT01103414
Acronym / sponsor ID: MSDC-C004
Conditions: Type 2 Diabetes
Keywords: Diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 356 participants (actual)
Lead sponsor: Metabolic Solutions Development CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Nov 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 14 Apr 2010 (estimated)
Results: Posted 22 Mar 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 evaluate the safety, tolerability and efficacy of three dose levels of Mitoglitazone™ (MSDC-0160) in patients with type 2 diabetes.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Mitoglitazone 50 mg capsules	Experimental	Drug: MitoglitazoneMitoglitazone 50 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Mitoglitazone 100 mg capsules	Experimental	Drug: MitoglitazoneMitoglitazone 100 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Mitoglitazone 150 mg capsules	Experimental	Drug: MitoglitazoneMitoglitazone 150 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Pioglitazone 45 mg capsules	Active comparator	Drug: PioglitazonePioglitazone 45 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Matching placebo	Placebo comparator	Drug: PlaceboPlacebo capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Males and females with Type 2 diabetes (fasting plasma glucose ≥126 mg/dL at screening, glycosylated hemoglobin [HbA1c] >7 and ≤10%, and Insulin C-peptide >1 ng/mL). Patients can be naïve to diabetes therapy or if taking metformin should be on a stable dose level for a period of at least 3 months prior to screening visit (no dose limit).
Between the ages of 18-75 years, inclusive.
Females should be either postmenopausal (at least 12 months since last menses) or surgically sterilized (bilateral tubal ligation or hysterectomy). Menopausal status will be verified by a follicle-stimulating hormone (FSH) test. If FSH levels are below 40 mIL/mL, some method of birth control must be used. Those with bilateral tubal ligation must also use a barrier method of birth control. In addition, all females must have a negative pregnancy test at Screen and Day 15 regardless of childbearing potential. Males with female partners of child-bearing potential must agree to use adequate contraceptive methods (including a condom, plus one other form of contraception) if engaging in sexual intercourse.
Body Mass Index (BMI) = 23 kg/m2 to 45 kg/m2 (inclusive).
Willing and able to make a screening visit to the clinic and seven visits over a 21 week period.

Key exclusion criteria (23 listed)

Use of TZDs or diabetes medications other than metformin (generic or Glucophage®) 3 months prior to screening.
History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
Fasting plasma glucose in excess of 240 mg/dl at screening
History of heart failure (including CHF) or previous cardiovascular event (myocardial infarct, by-pass surgery, or PTCA) within the past 6 months prior to screening.
ALT and/or AST levels that are twice the upper limit of normal; bilirubin levels that exceed 2 mg/dL; serum creatinine >1.5 mg/dL in men or > 1.4 mg/dL in women.

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
MitoglitazoneAlso: MSDC-016050 mg capsules, once daily for 84 days	Drug	Mitoglitazone 50 mg capsules
MitoglitazoneAlso: MSDC-0160Mitoglitazone 100 mg capsules, once daily for 84 days	Drug	Mitoglitazone 100 mg capsules
MitoglitazoneAlso: MSDC-0160Mitoglitazone 150 mg capsules, once daily for 84 days	Drug	Mitoglitazone 150 mg capsules
PioglitazoneAlso: ACTOSPioglitazone 45 mg, once daily for 84 days	Drug	Pioglitazone 45 mg capsules
PlaceboPlacebo, once daily for 84 days	Drug	Matching placebo

Primary outcome

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12.
Time frame: Baseline, Week 12
Change from baseline in fasting plasma glucose in response to three different doses of Mitoglitazone as compared to pioglitazone following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.

10 secondary outcomes

Change From Baseline in HbA1c
Time frame: 12 weeks
Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin
Time frame: 12 weeks
Change From Baseline to Week 12 Endpoint in Hematocrit
Time frame: 12 weeks
Change From Baseline in Hemoglobin
Time frame: 12 weeks
Change From Baseline in RBC
Time frame: 12 week
Change in Body Weight From Baseline to Week 12 Endpoint
Time frame: 12 weeks
Change From Baseline in Waist Circumference at Week 12 Endpoint
Time frame: 12 weeks
Presence of Edema Post Baseline During 12 Weeks Active Treatment
Time frame: 12 weeks
Changes in HDL Particle Size Subfractions From Baseline to Week 12
Time frame: 12 weeks
Changes in LDL Particle Size Subfractions From Baseline to Week 12
Time frame: 12 week

Results and safety

Results posted to the registry on 22 Mar 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
Mitoglitazone 50 mg Capsules	72	59
Mitoglitazone 100 mg Capsules	71	62
Mitoglitazone 150 mg Capsules	71	56
Pioglitazone 45 mg Capsules	71	64
Matching Placebo	71	56

Primary outcome: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12.

Time frame: Baseline, Week 12. Least squares mean (Standard Error). Unit: mg/dL

Measure	Mitoglitazone 50 mg Capsules n = 48	Mitoglitazone 100 mg Capsules n = 52	Mitoglitazone 150 mg Capsules n = 47	Pioglitazone 45 mg Capsules n = 55	Matching Placebo n = 56
Value	-5.3 (4.95)	-14.6 (4.74)	-25.1 (4.99)	-27.2 (4.61)	3.8 (4.59)

Mitoglitazone 50 mg Capsules vs Matching Placebo: Mean Difference (Net): -9.1 (95% CI -22.4 to 4.3), p = 0.1819, ANCOVA
Mitoglitazone 100 mg Capsules vs Matching Placebo: Mean Difference (Net): -18.4 (95% CI -31.4 to -5.4), p = 0.0057, ANCOVA
Mitoglitazone 150 mg Capsules vs Matching Placebo: Mean Difference (Net): -28.9 (95% CI -42.3 to -15.6), p <0.0001, ANCOVA

Population analysed: The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mitoglitazone 50 mg Capsules	0 of 71 (0%)	10 of 71 (14.1%)	Not reported
Mitoglitazone 100 mg Capsules	0 of 71 (0%)	5 of 71 (7%)	Not reported
Mitoglitazone 150 mg Capsules	1 of 70 (1.4%)	5 of 70 (7.1%)	Not reported
Pioglitazone 45 mg Capsules	3 of 71 (4.2%)	6 of 71 (8.5%)	Not reported
Matching Placebo	0 of 71 (0%)	6 of 71 (8.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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

MSDC

24 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 Mitoglitazone and Pioglitazone in people with Type 2 Diabetes, run by Metabolic Solutions Development Company at 24 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 6 inclusion and 23 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 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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 22 Mar 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 Fasting Plasma Glucose (FPG) at Week 12. (time frame: Baseline, Week 12). 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 NCT01103414.

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 28 Apr 2015.