Trial Outcomes & Findings for A Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSDC-0602 in Type 2 Diabetic Patients (NCT NCT01280695)

NCT ID: NCT01280695

Last Updated: 2014-04-14

Results Overview

To characterize the reduction in fasting plasma glucose in response to three different doses of MSDC-0602 Tablets as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

129 participants

Primary outcome timeframe

Baseline and 28 days

Results posted on

2014-04-14

Participant Flow

The study was conducted at 15 investigational sites between February 15, 2011 and July 6, 2011.

This study consisted of a 14-day placebo lead-in period and a 28-day double-blind treatment period. Eligible patients were randomized following the lead-in period based on a stratification criterion of current metformin use (yes, no) to one of the 5 treatments: MSDC 0602 100 mg, MSDC-0602 250 mg, MSDC-0602 500 mg, pioglitazone 45 mg, or placebo.

Participant milestones

Participant milestones
Measure	Placebo Placebo capsule once daily	MSDC-0602 100 mg MSDC-0602 capsule 100 mg once daily	MSDC-0602 250 mg MSDC-0602 capsule 250 mg once daily	MSDC-0602 500 mg MSDC-0602 capsule 500 mg once daily	Pioglitazone 45 mg Pioglitazone capsule 45 mg once daily
Overall Study STARTED	26	25	26	26	26
Overall Study COMPLETED	26	24	21	22	24
Overall Study NOT COMPLETED	0	1	5	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized, Double-Blind, Comparator- and Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSDC-0602 in Type 2 Diabetic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=26 Participants Placebo capsule once daily	MSDC-0602 100 mg n=25 Participants MSDC-0602 capsule 100 mg once daily	MSDC-0602 250 mg n=26 Participants MSDC-0602 capsule 250 mg once daily	MSDC-0602 500 mg n=26 Participants MSDC-0602 capsule 500 mg once daily	Pioglitazone 45 mg n=26 Participants Pioglitazone capsule 45 mg once daily	Total n=129 Participants Total of all reporting groups
Age, Continuous	57.2 years STANDARD_DEVIATION 8.87 • n=5 Participants	57.6 years STANDARD_DEVIATION 8.07 • n=7 Participants	57.7 years STANDARD_DEVIATION 7.35 • n=5 Participants	55.5 years STANDARD_DEVIATION 8.59 • n=4 Participants	55.7 years STANDARD_DEVIATION 8.01 • n=21 Participants	56.7 years STANDARD_DEVIATION 8.12 • n=8 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	10 Participants n=4 Participants	14 Participants n=21 Participants	52 Participants n=8 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	16 Participants n=7 Participants	13 Participants n=5 Participants	16 Participants n=4 Participants	12 Participants n=21 Participants	77 Participants n=8 Participants
Region of Enrollment United States	26 participants n=5 Participants	25 participants n=7 Participants	26 participants n=5 Participants	26 participants n=4 Participants	26 participants n=21 Participants	129 participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline and 28 days

Population: Per-Protocol Population:Included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures. The Per-Protocol Population was used for all efficacy measurements.

To characterize the reduction in fasting plasma glucose in response to three different doses of MSDC-0602 Tablets as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Placebo capsule once daily	MSDC-0602 100 mg n=22 Participants MSDC-0602 capsule 100 mg once daily	MSDC-0602 250 mg n=21 Participants MSDC-0602 capsule 250 mg once daily	MSDC-0602 500 mg n=22 Participants MSDC-0602 capsule 500 mg once daily	Pioglitazone 45 mg n=23 Participants Pioglitazone capsule 45 mg once daily
Change From Baseline in Fasting Plasma Glucose	6.0 mg/dL Inter-Quartile Range 8.90 • Interval -12.0 to 26.0	-0.5 mg/dL Inter-Quartile Range 9.77 • Interval -34.0 to 19.0	-20.0 mg/dL Inter-Quartile Range 10.06 • Interval -32.0 to 20.0	-16.0 mg/dL Inter-Quartile Range 9.68 • Interval -37.0 to 10.0	-22.0 mg/dL Inter-Quartile Range 9.38 • Interval -47.0 to -4.0

SECONDARY outcome

Timeframe: Baseline and 28 days

Population: The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.

To explore the drug effect difference in the reduction in hemoglobin A1c in response to three different doses of MSDC-0602 and pioglitazone (45 mg Actos®) as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Placebo capsule once daily	MSDC-0602 100 mg n=22 Participants MSDC-0602 capsule 100 mg once daily	MSDC-0602 250 mg n=21 Participants MSDC-0602 capsule 250 mg once daily	MSDC-0602 500 mg n=22 Participants MSDC-0602 capsule 500 mg once daily	Pioglitazone 45 mg n=23 Participants Pioglitazone capsule 45 mg once daily
Change From Baseline in HbA1c	0.14 percentage of hemoglobin Standard Error 0.081	0.09 percentage of hemoglobin Standard Error 0.088	-0.10 percentage of hemoglobin Standard Error 0.090	-0.17 percentage of hemoglobin Standard Error 0.088	-0.14 percentage of hemoglobin Standard Error 0.086

SECONDARY outcome

Timeframe: Baseline and 28 days

Population: The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.

To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on hematocrit, body weight, and edema following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Placebo capsule once daily	MSDC-0602 100 mg n=22 Participants MSDC-0602 capsule 100 mg once daily	MSDC-0602 250 mg n=21 Participants MSDC-0602 capsule 250 mg once daily	MSDC-0602 500 mg n=22 Participants MSDC-0602 capsule 500 mg once daily	Pioglitazone 45 mg n=23 Participants Pioglitazone capsule 45 mg once daily
Change From Baseline in Body Weight	0.12 kg Standard Error 0.267	0.25 kg Standard Error 0.291	-0.07 kg Standard Error 0.297	0.17 kg Standard Error 0.290	0.54 kg Standard Error 0.284

SECONDARY outcome

Timeframe: Baseline and 28 days

Population: The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.

To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo in hematocrit following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Placebo capsule once daily	MSDC-0602 100 mg n=22 Participants MSDC-0602 capsule 100 mg once daily	MSDC-0602 250 mg n=21 Participants MSDC-0602 capsule 250 mg once daily	MSDC-0602 500 mg n=22 Participants MSDC-0602 capsule 500 mg once daily	Pioglitazone 45 mg n=23 Participants Pioglitazone capsule 45 mg once daily
Change From Baseline in Hematocrit	-0.9 Change from baseline Standard Error 0.36	-0.9 Change from baseline Standard Error 0.39	-1.2 Change from baseline Standard Error 0.40	-1.7 Change from baseline Standard Error 0.39	-1.4 Change from baseline Standard Error 0.38

SECONDARY outcome

Timeframe: Baseline and 28 days

Population: The Per-Protocol population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.

To characterize the effects of 3 different doses of MSDC-0602 and pioglitazone as compared to placebo on insulin following once-daily dosing for 28 consecutive days

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Placebo capsule once daily	MSDC-0602 100 mg n=22 Participants MSDC-0602 capsule 100 mg once daily	MSDC-0602 250 mg n=21 Participants MSDC-0602 capsule 250 mg once daily	MSDC-0602 500 mg n=22 Participants MSDC-0602 capsule 500 mg once daily	Pioglitazone 45 mg n=23 Participants Pioglitazone capsule 45 mg once daily
Change in Fasting Plasma Insulin	3.06 µIU/mL Standard Deviation 1.434	-1.70 µIU/mL Standard Deviation 1.561	-1.11 µIU/mL Standard Deviation 1.601	-2.13 µIU/mL Standard Deviation 1.564	-3.21 µIU/mL Standard Deviation 1.523

SECONDARY outcome

Timeframe: Baseline and 28 days

Population: The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.

To evaluate the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on biomarkers of inflammatory status (high molecular weight adiponectin) following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Placebo capsule once daily	MSDC-0602 100 mg n=22 Participants MSDC-0602 capsule 100 mg once daily	MSDC-0602 250 mg n=21 Participants MSDC-0602 capsule 250 mg once daily	MSDC-0602 500 mg n=22 Participants MSDC-0602 capsule 500 mg once daily	Pioglitazone 45 mg n=23 Participants Pioglitazone capsule 45 mg once daily
Change From Baseline in High Molecular Weight Adiponectin	3.6 ng/mL Standard Error 15.28	44.1 ng/mL Standard Error 17.30	101.6 ng/mL Standard Error 17.00	139.2 ng/mL Standard Error 16.62	206.0 ng/mL Standard Error 16.35

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

MSDC-0602 100 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MSDC-0602 250 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

MSDC-0602 500 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Pioglitazone 45 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=26 participants at risk Placebo capsule once daily	MSDC-0602 100 mg n=25 participants at risk MSDC-0602 capsule 100 mg once daily	MSDC-0602 250 mg n=26 participants at risk MSDC-0602 capsule 250 mg once daily	MSDC-0602 500 mg n=26 participants at risk MSDC-0602 capsule 500 mg once daily	Pioglitazone 45 mg n=26 participants at risk Pioglitazone capsule 45 mg once daily
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	0.00% 0/26	0.00% 0/25	0.00% 0/26	0.00% 0/25	7.7% 2/26 • Number of events 2
General disorders Edema peripheral	7.7% 2/26 • Number of events 2	0.00% 0/25	0.00% 0/25	11.5% 3/26 • Number of events 3	7.7% 2/26 • Number of events 2
Nervous system disorders Headache	0.00% 0/26	0.00% 0/25	3.8% 1/26 • Number of events 1	7.7% 2/26 • Number of events 2	0.00% 0/26

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