Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of Mitoglitazone in Type 2 Diabetic Patients (NCT NCT01103414)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

356 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2015-04-28

Participant Flow

The study was conducted at 26 investigational sites in the United States. Over the course of the study, 786 patients were screened, 356 patients were randomized, 297 patients completed the study, and 258 patients completed the study for the Modified Per Protocol Population which required compliance with taking the active medications.

The study consisted of a 14-day, placebo lead-in period \& an 84-day double-blind treatment period. At screening, patients were required to have FPG ≥126 mg/dL, HbA1c 7-10%, and insulin C-peptide \>1 ng/mL. At the end of the lead-in period, eligible patients were randomized based on a stratification criterion of current metformin use (yes, no).

Participant milestones

Participant milestones
Measure	Mitoglitazone 50 mg Capsules Over-encapsulated Mitoglitazone 50 mg tablet	Mitoglitazone 100 mg Capsules Over-encapsulated Mitoglitazone 100 mg tablet	Mitoglitazone 150 mg Capsules Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet	Pioglitazone 45 mg Capsules Over-encapsulated ACTOS three 15 mg tablets	Matching Placebo Over-encapsulated placebo tablet
Overall Study STARTED	72	71	71	71	71
Overall Study COMPLETED	59	62	56	64	56
Overall Study NOT COMPLETED	13	9	15	7	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mitoglitazone 50 mg Capsules n=72 Participants Over-encapsulated Mitoglitazone 50 mg tablet	Mitoglitazone 100 mg Capsules n=71 Participants Over-encapsulated Mitoglitazone 100 mg tablet	Mitoglitazone 150 mg Capsules n=71 Participants Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet	Pioglitazone 45 mg Capsules n=71 Participants Over-encapsulated ACTOS three 15 mg tablets	Matching Placebo n=71 Participants Over-encapsulated placebo tablet	Total n=356 Participants Total of all reporting groups
Age, Continuous	54.3 years STANDARD_DEVIATION 9.70 • n=5 Participants	55.5 years STANDARD_DEVIATION 10.19 • n=7 Participants	56.0 years STANDARD_DEVIATION 8.76 • n=5 Participants	54.2 years STANDARD_DEVIATION 9.90 • n=4 Participants	53.4 years STANDARD_DEVIATION 8.76 • n=21 Participants	54.7 years STANDARD_DEVIATION 9.47 • n=10 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	29 Participants n=7 Participants	26 Participants n=5 Participants	32 Participants n=4 Participants	37 Participants n=21 Participants	166 Participants n=10 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	42 Participants n=7 Participants	45 Participants n=5 Participants	39 Participants n=4 Participants	34 Participants n=21 Participants	190 Participants n=10 Participants
Region of Enrollment United States	72 participants n=5 Participants	71 participants n=7 Participants	71 participants n=5 Participants	71 participants n=4 Participants	71 participants n=21 Participants	356 participants n=10 Participants
Fasting plasma glucose	176.1 mg/dL STANDARD_DEVIATION 39.62 • n=5 Participants	173.7 mg/dL STANDARD_DEVIATION 36.73 • n=7 Participants	170.2 mg/dL STANDARD_DEVIATION 44.22 • n=5 Participants	172.3 mg/dL STANDARD_DEVIATION 33.96 • n=4 Participants	170.2 mg/dL STANDARD_DEVIATION 43.78 • n=21 Participants	172.5 mg/dL STANDARD_DEVIATION 39.70 • n=10 Participants
HbA1c	8.2 percent STANDARD_DEVIATION 0.862 • n=5 Participants	8.09 percent STANDARD_DEVIATION 0.816 • n=7 Participants	8.00 percent STANDARD_DEVIATION 0.809 • n=5 Participants	8.08 percent STANDARD_DEVIATION 0.852 • n=4 Participants	8.04 percent STANDARD_DEVIATION 0.845 • n=21 Participants	8.08 percent STANDARD_DEVIATION 0.835 • n=10 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Mitoglitazone 50 mg Capsules n=48 Participants Over-encapsulated Mitoglitazone 50 mg tablet	Mitoglitazone 100 mg Capsules n=52 Participants Over-encapsulated Mitoglitazone 100 mg tablet	Mitoglitazone 150 mg Capsules n=47 Participants Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet	Pioglitazone 45 mg Capsules n=55 Participants Over-encapsulated ACTOS three 15 mg tablets	Matching Placebo n=56 Participants Over-encapsulated placebo tablet
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12.	-5.3 mg/dL Standard Error 4.95	-14.6 mg/dL Standard Error 4.74	-25.1 mg/dL Standard Error 4.99	-27.2 mg/dL Standard Error 4.61	3.8 mg/dL Standard Error 4.59

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Mitoglitazone 50 mg Capsules n=48 Participants Over-encapsulated Mitoglitazone 50 mg tablet	Mitoglitazone 100 mg Capsules n=52 Participants Over-encapsulated Mitoglitazone 100 mg tablet	Mitoglitazone 150 mg Capsules n=47 Participants Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet	Pioglitazone 45 mg Capsules n=55 Participants Over-encapsulated ACTOS three 15 mg tablets	Matching Placebo n=56 Participants Over-encapsulated placebo tablet
Change From Baseline in HbA1c	-0.10 percentage of hemoglobin Standard Deviation 0.129	-0.49 percentage of hemoglobin Standard Deviation 0.123	-0.57 percentage of hemoglobin Standard Deviation 0.130	-0.69 percentage of hemoglobin Standard Deviation 0.120	0.29 percentage of hemoglobin Standard Deviation 0.119

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

Percent change from baseline to week 12 endpoint in high molecular weight adiponectin

Outcome measures

Outcome measures
Measure	Mitoglitazone 50 mg Capsules n=48 Participants Over-encapsulated Mitoglitazone 50 mg tablet	Mitoglitazone 100 mg Capsules n=52 Participants Over-encapsulated Mitoglitazone 100 mg tablet	Mitoglitazone 150 mg Capsules n=47 Participants Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet	Pioglitazone 45 mg Capsules n=55 Participants Over-encapsulated ACTOS three 15 mg tablets	Matching Placebo n=56 Participants Over-encapsulated placebo tablet
Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin	45.2 percentage of baseline values Standard Deviation 18.15	94.4 percentage of baseline values Standard Deviation 17.44	132.4 percentage of baseline values Standard Deviation 18.34	287.0 percentage of baseline values Standard Deviation 16.94	4.9 percentage of baseline values Standard Deviation 16.82

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

Change from baseline to week 12 endpoint in hematocrit as an indication of fluid retention

Outcome measures

Outcome measures
Measure	Mitoglitazone 50 mg Capsules n=48 Participants Over-encapsulated Mitoglitazone 50 mg tablet	Mitoglitazone 100 mg Capsules n=52 Participants Over-encapsulated Mitoglitazone 100 mg tablet	Mitoglitazone 150 mg Capsules n=47 Participants Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet	Pioglitazone 45 mg Capsules n=55 Participants Over-encapsulated ACTOS three 15 mg tablets	Matching Placebo n=56 Participants Over-encapsulated placebo tablet
Change From Baseline to Week 12 Endpoint in Hematocrit	0.0 percentage of volume Standard Error 0.34	-0.9 percentage of volume Standard Error 0.33	-1.0 percentage of volume Standard Error 0.34	-1.7 percentage of volume Standard Error 0.32	0.0 percentage of volume Standard Error 0.32

SECONDARY outcome

Timeframe: 12 weeks

Population: All randomized patients who received at least 1 dose of randomized study medication and who had both baseline and week 12 assessments.

Change from baseline at week 12 endpoint in hemoglobin concentration

Outcome measures

Outcome measures
Measure	Mitoglitazone 50 mg Capsules n=61 Participants Over-encapsulated Mitoglitazone 50 mg tablet	Mitoglitazone 100 mg Capsules n=62 Participants Over-encapsulated Mitoglitazone 100 mg tablet	Mitoglitazone 150 mg Capsules n=59 Participants Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet	Pioglitazone 45 mg Capsules n=64 Participants Over-encapsulated ACTOS three 15 mg tablets	Matching Placebo n=56 Participants Over-encapsulated placebo tablet
Change From Baseline in Hemoglobin	-0.07 g/dL Standard Deviation 0.729	-0.38 g/dL Standard Deviation 0.720	-0.33 g/dL Standard Deviation .676	-0.60 g/dL Standard Deviation 0.827	-0.07 g/dL Standard Deviation 0.670

SECONDARY outcome

Timeframe: 12 week

Population: All randomized patients who received at least 1 dose of randomized study medication and who had both baseline and week 12 assessments

Change from baseline at week 12 endpoint in red blood cell concentration

Outcome measures

Outcome measures
Measure	Mitoglitazone 50 mg Capsules n=61 Participants Over-encapsulated Mitoglitazone 50 mg tablet	Mitoglitazone 100 mg Capsules n=62 Participants Over-encapsulated Mitoglitazone 100 mg tablet	Mitoglitazone 150 mg Capsules n=59 Participants Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet	Pioglitazone 45 mg Capsules n=64 Participants Over-encapsulated ACTOS three 15 mg tablets	Matching Placebo n=56 Participants Over-encapsulated placebo tablet
Change From Baseline in RBC	-0.014 10e-6 cells per uL Standard Deviation 0.2073	-0.098 10e-6 cells per uL Standard Deviation 0.2332	-0.107 10e-6 cells per uL Standard Deviation 0.2499	-0.211 10e-6 cells per uL Standard Deviation 0.2878	0.035 10e-6 cells per uL Standard Deviation 0.2480

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on body weight following once-daily dosing for 12

Outcome measures

Outcome measures
Measure	Mitoglitazone 50 mg Capsules n=48 Participants Over-encapsulated Mitoglitazone 50 mg tablet	Mitoglitazone 100 mg Capsules n=52 Participants Over-encapsulated Mitoglitazone 100 mg tablet	Mitoglitazone 150 mg Capsules n=47 Participants Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet	Pioglitazone 45 mg Capsules n=55 Participants Over-encapsulated ACTOS three 15 mg tablets	Matching Placebo n=56 Participants Over-encapsulated placebo tablet
Change in Body Weight From Baseline to Week 12 Endpoint	0.23 kg Standard Deviation 0.318	0.56 kg Standard Deviation 0.306	1.15 kg Standard Deviation 0.323	1.53 kg Standard Deviation 0.297	-0.71 kg Standard Deviation 0.294

SECONDARY outcome

Timeframe: 12 weeks

Population: All randomized patients who received at least 1 dose of randomized study medication and had both baseline and week 12 waist circumference assessments

Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on waist circumference following once-daily dosing for 12 weeks

Outcome measures

Outcome measures
Measure	Mitoglitazone 50 mg Capsules n=61 Participants Over-encapsulated Mitoglitazone 50 mg tablet	Mitoglitazone 100 mg Capsules n=62 Participants Over-encapsulated Mitoglitazone 100 mg tablet	Mitoglitazone 150 mg Capsules n=59 Participants Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet	Pioglitazone 45 mg Capsules n=65 Participants Over-encapsulated ACTOS three 15 mg tablets	Matching Placebo n=56 Participants Over-encapsulated placebo tablet
Change From Baseline in Waist Circumference at Week 12 Endpoint	0.1 cm Standard Deviation 3.39	-0.2 cm Standard Deviation 2.13	-0.4 cm Standard Deviation 4.02	0.7 cm Standard Deviation 2.95	-0.9 cm Standard Deviation 3.21

SECONDARY outcome

Timeframe: 12 weeks

Population: All randomized patients who received at least 1 dose of randomized study medication and had both a baseline and post baseline edema assessment

Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on presence of edema following once-daily dosing for 12 weeks

Outcome measures

Outcome measures
Measure	Mitoglitazone 50 mg Capsules n=68 Participants Over-encapsulated Mitoglitazone 50 mg tablet	Mitoglitazone 100 mg Capsules n=69 Participants Over-encapsulated Mitoglitazone 100 mg tablet	Mitoglitazone 150 mg Capsules n=70 Participants Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet	Pioglitazone 45 mg Capsules n=71 Participants Over-encapsulated ACTOS three 15 mg tablets	Matching Placebo n=70 Participants Over-encapsulated placebo tablet
Presence of Edema Post Baseline During 12 Weeks Active Treatment	8 participants	9 participants	4 participants	6 participants	8 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: The Modified Per-Protocol Population included all ITT patients who completed the 12-week, double-blind treatment period with no major deviations from protocol procedures, without any study medication non-compliance issues based on their pharmacokinetic data, and with both baseline and post-baseline NMR analysis of lipoprotein particle subfractions.

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

Outcome measures

Outcome measures
Measure	Mitoglitazone 50 mg Capsules n=43 Participants Over-encapsulated Mitoglitazone 50 mg tablet	Mitoglitazone 100 mg Capsules n=48 Participants Over-encapsulated Mitoglitazone 100 mg tablet	Mitoglitazone 150 mg Capsules n=45 Participants Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet	Pioglitazone 45 mg Capsules n=51 Participants Over-encapsulated ACTOS three 15 mg tablets	Matching Placebo n=56 Participants Over-encapsulated placebo tablet
Changes in HDL Particle Size Subfractions From Baseline to Week 12	0.00 nM Standard Deviation 0.25	0.05 nM Standard Deviation 0.40	0.10 nM Standard Deviation 0.30	0.20 nM Standard Deviation 0.50	0.00 nM Standard Deviation 0.25

SECONDARY outcome

Timeframe: 12 week

Population: The Modified Per-Protocol Population included all ITT patients who completed the 12-week, double-blind treatment period with no major deviations from protocol procedures, without any study medication non-compliance issues based on their pharmacokinetic data, and with both baseline and post-baseline NMR analysis of lipoprotein particle subfractions.

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

Outcome measures

Outcome measures
Measure	Mitoglitazone 50 mg Capsules n=43 Participants Over-encapsulated Mitoglitazone 50 mg tablet	Mitoglitazone 100 mg Capsules n=48 Participants Over-encapsulated Mitoglitazone 100 mg tablet	Mitoglitazone 150 mg Capsules n=45 Participants Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet	Pioglitazone 45 mg Capsules n=51 Participants Over-encapsulated ACTOS three 15 mg tablets	Matching Placebo n=56 Participants Over-encapsulated placebo tablet
Changes in LDL Particle Size Subfractions From Baseline to Week 12	0.20 nM Standard Deviation 0.60	0.20 nM Standard Deviation 0.55	0.30 nM Standard Deviation 0.50	0.60 nM Standard Deviation 0.70	0.00 nM Standard Deviation 0.40

Adverse Events

Mitoglitazone 50 mg Capsules

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Mitoglitazone 100 mg Capsules

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Mitoglitazone 150 mg Capsules

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Pioglitazone 45 mg Capsules

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Matching Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mitoglitazone 50 mg Capsules n=71 participants at risk Over-encapsulated Mitoglitazone 50 mg tablet	Mitoglitazone 100 mg Capsules n=71 participants at risk Over-encapsulated Mitoglitazone 100 mg tablet	Mitoglitazone 150 mg Capsules n=70 participants at risk Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet	Pioglitazone 45 mg Capsules n=71 participants at risk Over-encapsulated ACTOS three 15 mg tablets	Matching Placebo n=71 participants at risk Over-encapsulated placebo tablet
Skin and subcutaneous tissue disorders skin laceration	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	1.4% 1/70 • Number of events 1 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.
Nervous system disorders Syncope	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/70 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	1.4% 1/71 • Number of events 1 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.
Skin and subcutaneous tissue disorders cellulitis	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/70 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	1.4% 1/71 • Number of events 1 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.
Renal and urinary disorders benign prostatic hyperplasia and calculus bladder	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/70 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	1.4% 1/71 • Number of events 1 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.

Other adverse events

Other adverse events
Measure	Mitoglitazone 50 mg Capsules n=71 participants at risk Over-encapsulated Mitoglitazone 50 mg tablet	Mitoglitazone 100 mg Capsules n=71 participants at risk Over-encapsulated Mitoglitazone 100 mg tablet	Mitoglitazone 150 mg Capsules n=70 participants at risk Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet	Pioglitazone 45 mg Capsules n=71 participants at risk Over-encapsulated ACTOS three 15 mg tablets	Matching Placebo n=71 participants at risk Over-encapsulated placebo tablet
Infections and infestations Urinary Tract Infection	2.8% 2/71 • Number of events 2 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	2.9% 2/70 • Number of events 2 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	2.8% 2/71 • Number of events 2 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	4.2% 3/71 • Number of events 3 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.
Infections and infestations Nasopharyngitis	5.6% 4/71 • Number of events 4 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	2.8% 2/71 • Number of events 2 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/70 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	1.4% 1/71 • Number of events 1 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.
Nervous system disorders Headache	2.8% 2/71 • Number of events 2 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	4.2% 3/71 • Number of events 3 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	1.4% 1/70 • Number of events 1 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	1.4% 1/71 • Number of events 1 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	1.4% 1/71 • Number of events 1 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.
Gastrointestinal disorders Diarrhea & Nausea	2.8% 2/71 • Number of events 2 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	0.00% 0/71 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	2.9% 2/70 • Number of events 2 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	4.2% 3/71 • Number of events 3 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.	1.4% 1/71 • Number of events 1 The Safety Population includes all randomized subjects who received at least one dose of randomized study medication. Two subjects withdrew from the study during the placebo lead-in period.

Additional Information

Dr. Jerry Colca, President & CSO

Mstabolic Solutions Company. LLC

Phone: 269.343.6732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60