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

• Sponsor: VIVUS LLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00737633
• Collaborator: Synteract, Inc. (Industry), Sentrx (Industry)
• Enrollment: 101
• Locations: 9
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 11.2
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

This study is an extension of a study that has been ongoing for 1 year. The purpose of this open label study is to see the how well type 2 diabetics respond to VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an extended period of time. All subjects eligible to enroll into this study will receive study drug.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Drug: VI-0521	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Non-Randomized Multicenter Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 16-Week population Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)	Drug: VI-0521; Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks
Experimental: 72-Week population Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)	Drug: VI-0521; Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c From Baseline to Week 72 [Baseline to 72 weeks]

Secondary Outcome Measures

1. Percent Weight Change From Baseline to Week 72 [Baseline to 72 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have completed the qualifying DM-230 trial

• If females of child-bearing potential, subjects must be using adequate contraception

• Provide written informed consent

• Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures

• Be greater than 80% compliant in study medication use during the last three visits for DM-230

Exclusion Criteria:

• Subjects who have developed one or more morbidities during the DM-230 trial that would pose a safety concern

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Birmingham	Alabama	United States
2	Research Site	Los Angeles	California	United States
3	Research Site	San Francisco	California	United States
4	Research Site	Spring Valley	California	United States
5	Research Site	Walnut Creek	California	United States
6	Research Site	Bethesda	Maryland	United States
7	Research Site	Austin	Texas	United States
8	Research Site	San Antonio	Texas	United States
9	Research Site	Richmond	Virginia	United States

Sponsors and Collaborators

• VIVUS LLC
• Synteract, Inc.
• Sentrx

Investigators

• Study Director: Barbara Troupin, MD, MBA, VIVUS LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VIVUS LLC
• ClinicalTrials.gov Identifier: NCT00737633
• Other Study ID Numbers: DM-231
• First Posted: Aug 19, 2008
• Last Update Posted: Sep 10, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by VIVUS LLC: Diabetes; Type 2 Diabetes; Diabetes Mellitus; Metabolic Diseases; Glucose Metabolism Disorders; Glycemic Control

Study Results

Participant Flow

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

Arm/Group Title	16-week Population	72-week Population
Arm/Group Description	Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)	Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
Period Title: Overall Study
STARTED	44	57
COMPLETED	0	0
NOT COMPLETED	44	57

Baseline Characteristics

Arm/Group Title	16-week Population	72-week Population	Total
Arm/Group Description	subjects who were randomized to placebo in previous study	subjects who were randomized to active during previous study	Total of all reporting groups
Overall Participants	44	57	101
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.2 (8.6)	49.5 (7.0)	49.8 (7.7)
Sex: Female, Male (Count of Participants)
Female	25 56.8%	48 84.2%	73 72.3%
Male	19 43.2%	9 15.8%	28 27.7%
Region of Enrollment (participants) [Number]
United States	44 100%	57 100%	101 100%

Outcome Measures

1. Primary Outcome

Title	Change in HbA1c From Baseline to Week 72
Time Frame	Baseline to 72 weeks

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT)

Arm/Group Title	16-week Population	72-week Population
Arm/Group Description	Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)	Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
Measure Participants	44	57
Mean (Standard Deviation) [percent change]	-0.5 (0.79)	-1.4 (1.34)

2. Secondary Outcome

Title	Percent Weight Change From Baseline to Week 72
Time Frame	Baseline to 72 weeks

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT)

Arm/Group Title	16-week Population	72-week Population
Arm/Group Description	Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)	Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
Measure Participants	44	57
Mean (Standard Deviation) [percent change]	-5.7 (4.64)	-10.1 (8.7)

Adverse Events

Time Frame	AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Arm/Group Title	16-week Population		72-week Population
Arm/Group Description	subjects who were randomized to placebo in previous study		subjects who were randomized to active during previous study
All Cause Mortality
	16-week Population		72-week Population
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	16-week Population		72-week Population
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/44 (2.3%)		0/57 (0%)
Cardiac disorders
Coronary Artery Disease	1/44 (2.3%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	16-week Population		72-week Population
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/44 (75%)		34/57 (59.6%)
Eye disorders
eye pain	2/44 (4.5%)		1/57 (1.8%)
lacrimation increased	2/44 (4.5%)		0/57 (0%)
chromatopsia	2/44 (4.5%)		0/57 (0%)
Gastrointestinal disorders
nausea	4/44 (9.1%)		3/57 (5.3%)
diarrhea	1/44 (2.3%)		3/57 (5.3%)
constipation	7/44 (15.9%)		0/57 (0%)
gastritis	0/44 (0%)		2/57 (3.5%)
dyspepsia	1/44 (2.3%)		2/57 (3.5%)
dry mouth	5/44 (11.4%)		1/57 (1.8%)
abdominal distension	2/44 (4.5%)		1/57 (1.8%)
General disorders
fatigue	6/44 (13.6%)		1/57 (1.8%)
irritability	2/44 (4.5%)		1/57 (1.8%)
Infections and infestations
upper respiratory tract infection	3/44 (6.8%)		2/57 (3.5%)
gastroenteritis	2/44 (4.5%)		2/57 (3.5%)
sinusitis	2/44 (4.5%)		2/57 (3.5%)
nasopharyngitis	0/44 (0%)		3/57 (5.3%)
influenza	1/44 (2.3%)		2/57 (3.5%)
Injury, poisoning and procedural complications
back injury	2/44 (4.5%)		0/57 (0%)
Metabolism and nutrition disorders
hypoglycemia	6/44 (13.6%)		8/57 (14%)
Nervous system disorders
parasthesia	2/44 (4.5%)		3/57 (5.3%)
dizziness	7/44 (15.9%)		0/57 (0%)
headache	3/44 (6.8%)		1/57 (1.8%)
dysgeusia	6/44 (13.6%)		0/57 (0%)
Psychiatric disorders
insomnia	6/44 (13.6%)		2/57 (3.5%)
anxiety	2/44 (4.5%)		2/57 (3.5%)
Respiratory, thoracic and mediastinal disorders
nasal congestion	1/44 (2.3%)		2/57 (3.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.