Trial Outcomes & Findings for A Placebo Controlled Safety and Efficacy Study of MSDC-0160 in Type 2 Diabetes With Active Comparator (NCT NCT00760578)

Results Overview

Change from baseline of averaged postprandial glucose (mmol/L) in response to a Mixed-meal tolerance (MMT) test.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

86 participants

Primary outcome timeframe

28 days

Results posted on

2013-05-03

Participant Flow

The study was conducted in the United States by 10 investigators between 26 Sep 2008 and 02 Feb 2009.

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.

Participant milestones

Participant milestones
Measure	MSDC-0160 90 mg MSDC-0160 90 mg once daily	MSDC-0160 220 mg MSDC-0160 220 mg once daily	Pioglitazone Pioglitazone 45 mg once daily	Placebo Microcrystaline cellulose once daily
Overall Study STARTED	22	21	21	22
Overall Study Entered Drug Treatment Period	21	20	19	22
Overall Study COMPLETED	19	19	16	18
Overall Study NOT COMPLETED	3	2	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MSDC-0160 90 mg n=22 Participants MSDC-0160 90 mg once daily	MSDC-0160 220 mg n=21 Participants MSDC-0160 220 mg once daily	Pioglitazone n=21 Participants Pioglitazone 45 mg once daily	Placebo n=22 Participants Microcrystaline cellulose once daily	Total n=86 Participants Total of all reporting groups
Age Continuous	56.3 years STANDARD_DEVIATION 8.20 • n=5 Participants	53.7 years STANDARD_DEVIATION 9.22 • n=7 Participants	57.7 years STANDARD_DEVIATION 6.38 • n=5 Participants	54.5 years STANDARD_DEVIATION 8.79 • n=4 Participants	55.5 years STANDARD_DEVIATION 8.15 • n=21 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants	13 Participants n=4 Participants	46 Participants n=21 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	7 Participants n=5 Participants	9 Participants n=4 Participants	40 Participants n=21 Participants
Region of Enrollment United States	22 participants n=5 Participants	21 participants n=7 Participants	21 participants n=5 Participants	22 participants n=4 Participants	86 participants n=21 Participants

PRIMARY outcome

Timeframe: 28 days

Population: 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.

Change from baseline of averaged postprandial glucose (mmol/L) in response to a Mixed-meal tolerance (MMT) test.

Outcome measures

Outcome measures
Measure	Mitoglitazone 90 mg n=20 Participants Mitoglitazone 90 mg taken once daily for 28 days	Mitoglitazone 220 mg n=19 Participants Mitaglitazone 220 mg taken once daily for 28 days	Pioglitazone 45 mg n=16 Participants Pioglitazone 45 mg taken once daily for 28 days	Placebo n=21 Participants Placebo (microcrystalline cellulose) taken once daily for 28 days
Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test	0.16 mmol/L Standard Error 0.349	-0.44 mmol/L Standard Error 0.358	-1.10 mmol/L Standard Error 0.390	0.51 mmol/L Standard Error 0.340

SECONDARY outcome

Timeframe: After four weeks of active therapy

Population: 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.

Change from baseline in averaged post prandial insulin levels in response to a mixed-meal tolerance test.

Outcome measures

Outcome measures
Measure	Mitoglitazone 90 mg n=20 Participants Mitoglitazone 90 mg taken once daily for 28 days	Mitoglitazone 220 mg n=19 Participants Mitaglitazone 220 mg taken once daily for 28 days	Pioglitazone 45 mg n=16 Participants Pioglitazone 45 mg taken once daily for 28 days	Placebo n=21 Participants Placebo (microcrystalline cellulose) taken once daily for 28 days
Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test	0.74 uIU/mL Standard Error 4.664	-9.77 uIU/mL Standard Error 4.785	-12.24 uIU/mL Standard Error 5.215	-1.60 uIU/mL Standard Error 4.552

SECONDARY outcome

Timeframe: After 28 days of active therapy

Population: 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.

Change from baseline in Free Fatty Acids (FFAs)following 28 days of active therapy, as part of a lipid profile assessment

Outcome measures

Outcome measures
Measure	Mitoglitazone 90 mg n=20 Participants Mitoglitazone 90 mg taken once daily for 28 days	Mitoglitazone 220 mg n=19 Participants Mitaglitazone 220 mg taken once daily for 28 days	Pioglitazone 45 mg n=16 Participants Pioglitazone 45 mg taken once daily for 28 days	Placebo n=21 Participants Placebo (microcrystalline cellulose) taken once daily for 28 days
Change From Baseline in FFAs	-0.05 mmol/L Standard Error 0.051	-0.15 mmol/L Standard Error 0.052	-0.19 mmol/L Standard Error 0.057	-0.01 mmol/L Standard Error 0.050

SECONDARY outcome

Timeframe: 28 days

Population: 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.

Change compared to baseline in triglycerides following 28 days of active therapy, as part of a lipid profile assessment

Outcome measures

Outcome measures
Measure	Mitoglitazone 90 mg n=20 Participants Mitoglitazone 90 mg taken once daily for 28 days	Mitoglitazone 220 mg n=19 Participants Mitaglitazone 220 mg taken once daily for 28 days	Pioglitazone 45 mg n=16 Participants Pioglitazone 45 mg taken once daily for 28 days	Placebo n=21 Participants Placebo (microcrystalline cellulose) taken once daily for 28 days
Change From Baseline in Triglycerides	0.12 mmol/L Standard Error 0.160	-0.21 mmol/L Standard Error 0.164	-0.49 mmol/L Standard Error 0.179	0.15 mmol/L Standard Error 0.156

SECONDARY outcome

Timeframe: 28 days

Population: 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.

Change from baseline in HDL following 28 days of active therapy, as part of a lipid profile assessment

Outcome measures

Outcome measures
Measure	Mitoglitazone 90 mg n=20 Participants Mitoglitazone 90 mg taken once daily for 28 days	Mitoglitazone 220 mg n=19 Participants Mitaglitazone 220 mg taken once daily for 28 days	Pioglitazone 45 mg n=16 Participants Pioglitazone 45 mg taken once daily for 28 days	Placebo n=21 Participants Placebo (microcrystalline cellulose) taken once daily for 28 days
Change From Baseline in HDL	0.00 mmol/L Standard Error 0.034	0.11 mmol/L Standard Error 0.034	0.09 mmol/L Standard Error 0.038	-0.03 mmol/L Standard Error 0.033

POST_HOC outcome

Timeframe: 28 days

Population: 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.

Change from baseline in fasting plasma glucose (FPG) following 28 days of active therapy

Outcome measures

Outcome measures
Measure	Mitoglitazone 90 mg n=20 Participants Mitoglitazone 90 mg taken once daily for 28 days	Mitoglitazone 220 mg n=19 Participants Mitaglitazone 220 mg taken once daily for 28 days	Pioglitazone 45 mg n=16 Participants Pioglitazone 45 mg taken once daily for 28 days	Placebo n=21 Participants Placebo (microcrystalline cellulose) taken once daily for 28 days
Change From Baseline in FPG	-0.20 mmol/L Standard Error 0.263	-0.97 mmol/L Standard Error 0.270	-1.38 mmol/L Standard Error 0.294	-0.04 mmol/L Standard Error 0.257

POST_HOC outcome

Timeframe: 28 days

Population: 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.

Change from Baseline in insulin levels following 28 days of active therapy

Outcome measures

Outcome measures
Measure	Mitoglitazone 90 mg n=20 Participants Mitoglitazone 90 mg taken once daily for 28 days	Mitoglitazone 220 mg n=19 Participants Mitaglitazone 220 mg taken once daily for 28 days	Pioglitazone 45 mg n=16 Participants Pioglitazone 45 mg taken once daily for 28 days	Placebo n=21 Participants Placebo (microcrystalline cellulose) taken once daily for 28 days
Change From Baseline in Insulin	-5.01 uIU/mL Standard Error 1.820	-2.91 uIU/mL Standard Error 1.867	-6.58 uIU/mL Standard Error 2.034	-0.70 uIU/mL Standard Error 1.776

Adverse Events

MSDC-0160 90 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Pioglitazone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

MSDC-0160 220 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MSDC-0160 90 mg n=22 participants at risk MSDC-0160 90 mg once daily	Placebo n=22 participants at risk Microcrystaline cellulose once daily	Pioglitazone n=21 participants at risk Pioglitazone 45 mg once daily	MSDC-0160 220 mg n=21 participants at risk MSDC-0160 220 mg once daily
Gastrointestinal disorders Diarrhoea	9.1% 2/22 • Number of events 2	9.1% 2/22 • Number of events 2	0.00% 0/21	0.00% 0/21
General disorders Peripheral Oedema	9.1% 2/22 • Number of events 2	4.5% 1/22 • Number of events 1	9.5% 2/21 • Number of events 2	9.5% 2/21 • Number of events 2

Additional Information

Jerry Colca, PhD

Metabolic Solutions Development Company

Phone: 269-343-6732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60