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The purpose of this study is to determine if MSDC-0160 is effective in the treatment of Type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Microcrystaline cellulose once daily |
|
| Pioglitazone | Active Comparator | Pioglitazone 45 mg once daily |
|
| MSDC-0160 90 mg | Experimental | MSDC-0160 90 mg once daily |
|
| MSDC-0160 220 mg | Experimental | MSDC-0160 220 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Once daily, oral |
| |
| Pioglitazone |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After four weeks of active therapy |
| Change From Baseline in FFAs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry R Colca, PhD | Metabolic Solutions Development Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
This was a Ph 2A, double-blind, randomized, comparator- & placebo-controlled study of Mitoglitazone in otherwise healthy adult patients with type 2 diabetes. The study consisted of a maximum 21-day screening period, a 2 week, single-blind, placebo lead-in period, a 4 week, double-blind treatment period and a 1 week posttreatment follow-up period.
The study was conducted in the United States by 10 investigators between 26 Sep 2008 and 02 Feb 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | MSDC-0160 90 mg | MSDC-0160 90 mg once daily |
| FG001 | MSDC-0160 220 mg | MSDC-0160 220 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Once daily, oral |
|
| MSDC-0160 90 mg | Drug | Once daily, oral |
|
| MSDC-0160 220 mg | Drug | Once daily, oral |
|
Change from baseline in Free Fatty Acids (FFAs)following 28 days of active therapy, as part of a lipid profile assessment |
| 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 | 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 | 28 days |
| Miami Gardens |
| Florida |
| United States |
| West Palm Beach | Florida | United States |
| Kalamazoo | Michigan | United States |
| Greenville | South Carolina | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Renton | Washington | United States |
| FG002 |
| Pioglitazone |
Pioglitazone 45 mg once daily |
| FG003 | Placebo | Microcrystaline cellulose once daily |
| Entered Drug Treatment Period |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MSDC-0160 90 mg | MSDC-0160 90 mg once daily |
| BG001 | MSDC-0160 220 mg | MSDC-0160 220 mg once daily |
| BG002 | Pioglitazone | Pioglitazone 45 mg once daily |
| BG003 | Placebo | Microcrystaline cellulose once daily |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | mmol/L | 28 days |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) 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. | Posted | Least Squares Mean | Standard Error | uIU/mL | After four weeks of active therapy |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 | All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) 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. | Posted | Least Squares Mean | Standard Error | mmol/L | After 28 days of active therapy |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Triglycerides | Change compared to baseline in triglycerides following 28 days of active therapy, as part of a lipid profile assessment | All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) 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. | Posted | Least Squares Mean | Standard Error | mmol/L | 28 days |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HDL | Change from baseline in HDL following 28 days of active therapy, as part of a lipid profile assessment | All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) 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. | Posted | Least Squares Mean | Standard Error | mmol/L | 28 days |
| ||||||||||||||||||||||||||||||||||||
| Post-Hoc | Change From Baseline in FPG | Change from baseline in fasting plasma glucose (FPG) following 28 days of active therapy | All patients who were compliant during the treatment period and who had Day 8 and Day 43 fasting plasma glucose values. 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. | Posted | Least Squares Mean | Standard Error | mmol/L | 28 days |
| ||||||||||||||||||||||||||||||||||||
| Post-Hoc | Change From Baseline in Insulin | Change from Baseline in insulin levels following 28 days of active therapy | All patients who were compliant during the treatment period and who had a Day 8 and Day 43 pre-dose 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. | Posted | Least Squares Mean | Standard Error | uIU/mL | 28 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MSDC-0160 90 mg | MSDC-0160 90 mg once daily | 0 | 22 | 4 | 22 | ||
| EG001 | Placebo | Microcrystaline cellulose once daily | 0 | 22 | 3 | 22 | ||
| EG002 | Pioglitazone | Pioglitazone 45 mg once daily | 0 | 21 | 2 | 21 | ||
| EG003 | MSDC-0160 220 mg | MSDC-0160 220 mg once daily | 0 | 21 | 2 | 21 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Peripheral Oedema | General disorders | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerry Colca, PhD | Metabolic Solutions Development Company | 269-343-6732 | jcolca@msdrx.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| C581095 | MSDC-0160 |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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