Trial Outcomes & Findings for Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults (NCT NCT00737633)

NCT ID: NCT00737633

Last Updated: 2012-09-10

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

101 participants

Primary outcome timeframe

Baseline to 72 weeks

Results posted on

2012-09-10

Participant Flow

This is an extension study to OB-202 (NCT00486291) and DM-230 (NCT00600067)

Participant milestones

Participant milestones
Measure	16-week Population Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)	72-week Population Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
Overall Study STARTED	44	57
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	44	57

Reasons for withdrawal

Reasons for withdrawal
Measure	16-week Population Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)	72-week Population Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
Overall Study Study terminated by sponsor	44	55
Overall Study Lost to Follow-up	0	1
Overall Study protocol non-compliance	0	1

Baseline Characteristics

Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	72-week Population n=57 Participants subjects who were randomized to active during previous study	Total n=101 Participants Total of all reporting groups	16-week Population n=44 Participants subjects who were randomized to placebo in previous study
Age Continuous	49.5 years STANDARD_DEVIATION 7.0 • n=7 Participants	49.8 years STANDARD_DEVIATION 7.7 • n=5 Participants	50.2 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	48 Participants n=7 Participants	73 Participants n=5 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=7 Participants	28 Participants n=5 Participants	19 Participants n=5 Participants
Region of Enrollment United States	57 participants n=7 Participants	101 participants n=5 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 72 weeks

Population: Intent-to-treat (ITT)

Outcome measures

Outcome measures
Measure	16-week Population n=44 Participants Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)	72-week Population n=57 Participants Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
Change in HbA1c From Baseline to Week 72	-0.5 percent change Standard Deviation 0.79	-1.4 percent change Standard Deviation 1.34

SECONDARY outcome

Timeframe: Baseline to 72 weeks

Population: Intent-to-treat (ITT)

Outcome measures

Outcome measures
Measure	16-week Population n=44 Participants Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)	72-week Population n=57 Participants Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
Percent Weight Change From Baseline to Week 72	-5.7 percent change Standard Deviation 4.64	-10.1 percent change Standard Deviation 8.7

Adverse Events

16-week Population

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

72-week Population

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	16-week Population n=44 participants at risk subjects who were randomized to placebo in previous study	72-week Population n=57 participants at risk subjects who were randomized to active during previous study
Cardiac disorders Coronary Artery Disease	2.3% 1/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.

Other adverse events

Additional Information

Wesley W Day, PhD

Vivus, Inc

Phone: 650-934-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After Sponsor's written notification that publication of results is no longer planned or 12 months after termination of the study at all sites, Institution \& PI may publish, upon written approval from Sponsor, results of the Study. Sponsor will be given the opportunity to review any proposed publication at least 60 days prior to submission for publication or disclosure. Upon Sponsor's written request, Institution and PI shall not publish or disclose information related to the Study.
Publication restrictions are in place

Restriction type: OTHER

Measure	16-week Population n=44 participants at risk subjects who were randomized to placebo in previous study	72-week Population n=57 participants at risk subjects who were randomized to active during previous study
Infections and infestations upper respiratory tract infection	6.8% 3/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	3.5% 2/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Infections and infestations gastroenteritis	4.5% 2/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	3.5% 2/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Infections and infestations sinusitis	4.5% 2/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	3.5% 2/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Infections and infestations nasopharyngitis	0.00% 0/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	5.3% 3/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Infections and infestations influenza	2.3% 1/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	3.5% 2/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders parasthesia	4.5% 2/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	5.3% 3/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders dizziness	15.9% 7/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders headache	6.8% 3/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.8% 1/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders dysgeusia	13.6% 6/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders nausea	9.1% 4/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	5.3% 3/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders diarrhea	2.3% 1/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	5.3% 3/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders constipation	15.9% 7/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders gastritis	0.00% 0/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	3.5% 2/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders dyspepsia	2.3% 1/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	3.5% 2/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders dry mouth	11.4% 5/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.8% 1/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders abdominal distension	4.5% 2/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.8% 1/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Metabolism and nutrition disorders hypoglycemia	13.6% 6/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	14.0% 8/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Psychiatric disorders insomnia	13.6% 6/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	3.5% 2/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Psychiatric disorders anxiety	4.5% 2/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	3.5% 2/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
General disorders fatigue	13.6% 6/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.8% 1/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
General disorders irritability	4.5% 2/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.8% 1/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Injury, poisoning and procedural complications back injury	4.5% 2/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Eye disorders eye pain	4.5% 2/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.8% 1/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Eye disorders lacrimation increased	4.5% 2/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Eye disorders chromatopsia	4.5% 2/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Respiratory, thoracic and mediastinal disorders nasal congestion	2.3% 1/44 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	3.5% 2/57 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.