A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults

• Sponsor: VIVUS LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00600067
• Collaborator: Synteract, Inc. (Industry), Sentrx (Industry)
• Enrollment: 130
• Locations: 9
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 14.4
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Drug: Phentermine/Topiramate; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double Blind Multicenter Study to Evaluate the Long-term Safety and Efficacy of VI-0521 Relative to Placebo in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Phentermine/Topiramate; phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks
Placebo Comparator: 2	Drug: Placebo; Oral placebo capsules, once daily, 28 weeks

Outcome Measures

Primary Outcome Measures

1. HbA1c Change From Baseline Week 0 to Week 56 [Baseline to 56 weeks]

Secondary Outcome Measures

1. Percent Weight Loss From Baseline to Week 56 [Baseline to 56 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have completed the qualifying OB-202 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

Exclusion Criteria:

• Subjects who have developed one or more morbidities during the OB-202 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: NCT00600067
• Other Study ID Numbers: DM-230
• First Posted: Jan 24, 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
• Additional relevant MeSH terms: Topiramate; Phentermine

Study Results

Participant Flow

Recruitment Details	Subject recruitment occurred in 10 investigative sites in the U.S. between January 2008 and October 2008

Arm/Group Title	Placebo	VI-0521
Arm/Group Description	phentermine 15 mg/topiramate 92 mg
Period Title: Overall Study
STARTED	55	75
COMPLETED	52	68
NOT COMPLETED	3	7

Baseline Characteristics

Arm/Group Title	Placebo	Active	Total
Arm/Group Description	PHEN/TPM 15/92	Total of all reporting groups
Overall Participants	55	75	130
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.5 (8.58)	49.7 (7.51)	49.6 (7.95)
Sex: Female, Male (Count of Participants)
Female	32 58.2%	58 77.3%	90 69.2%
Male	23 41.8%	17 22.7%	40 30.8%
Region of Enrollment (participants) [Number]
United States	55 100%	75 100%	130 100%

Outcome Measures

1. Primary Outcome

Title	HbA1c Change From Baseline Week 0 to Week 56
Time Frame	Baseline to 56 weeks

Outcome Measure Data

Analysis Population Description

Intent-to-treat Last-observation-carried-forward (ITT-LOCF)

Arm/Group Title	Placebo	VI-0521
Arm/Group Description	phentermine 15mg/topiramate 92 mg
Measure Participants	55	75
Least Squares Mean (Standard Error) [percent change]	-1.2 (0.13)	-1.56 (0.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, VI-0521
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0381
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.36
	Confidence Interval	(2-Sided) 95%; -0.69 to -0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.17
	Estimation Comments

2. Secondary Outcome

Title	Percent Weight Loss From Baseline to Week 56
Time Frame	Baseline to 56 weeks

Outcome Measure Data

Analysis Population Description

Intent-to-treat Last-observation-carried-forward (ITT-LOCF)

Arm/Group Title	Placebo	VI-0521
Arm/Group Description	phentermine 15mg/topiramate 92mg
Measure Participants	55	75
Least Squares Mean (Standard Error) [percent change]	-2.71 (0.95)	-9.41 (0.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, VI-0521
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.70
	Confidence Interval	(2-Sided) 95%; -9.18 to -4.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.26
	Estimation Comments

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	Placebo		Active
Arm/Group Description	PHEN/TPM 15/92
All Cause Mortality
	Placebo		Active
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Active
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/55 (1.8%)		2/75 (2.7%)
Hepatobiliary disorders
cholelithiasis	1/55 (1.8%)		0/75 (0%)
Musculoskeletal and connective tissue disorders
costochondritis	0/55 (0%)		1/75 (1.3%)
intervertebral disc protrusion	0/55 (0%)		1/75 (1.3%)
Other (Not Including Serious) Adverse Events
	Placebo		Active
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/55 (61.8%)		48/75 (64%)
Eye disorders
vision blurred	2/55 (3.6%)		0/75 (0%)
Gastrointestinal disorders
constipation	1/55 (1.8%)		4/75 (5.3%)
diarrhea	2/55 (3.6%)		0/75 (0%)
nausea	1/55 (1.8%)		1/75 (1.3%)
vomiting	0/55 (0%)		1/75 (1.3%)
abdominal pain	1/55 (1.8%)		1/75 (1.3%)
General disorders
pyrexia	2/55 (3.6%)		0/75 (0%)
Infections and infestations
upper respiratory tract infection	8/55 (14.5%)		7/75 (9.3%)
Influenza	0/55 (0%)		2/75 (2.7%)
nasopharyngitis	1/55 (1.8%)		1/75 (1.3%)
bronchitis	0/55 (0%)		1/75 (1.3%)
urinary tract infection	1/55 (1.8%)		1/75 (1.3%)
sinusitis	1/55 (1.8%)		0/75 (0%)
Metabolism and nutrition disorders
hypoglycemia	5/55 (9.1%)		9/75 (12%)
diabetes mellitus	5/55 (9.1%)		1/75 (1.3%)
hypokalemia	0/55 (0%)		2/75 (2.7%)
Musculoskeletal and connective tissue disorders
back pain	3/55 (5.5%)		3/75 (4%)
pain in extremity	2/55 (3.6%)		1/75 (1.3%)
arthralgia	1/55 (1.8%)		1/75 (1.3%)
Nervous system disorders
paresthesia	0/55 (0%)		4/75 (5.3%)
dizziness	1/55 (1.8%)		1/75 (1.3%)
headache	1/55 (1.8%)		1/75 (1.3%)
hypoesthesia	1/55 (1.8%)		2/75 (2.7%)
Psychiatric disorders
insomnia	0/55 (0%)		1/75 (1.3%)
anxiety	1/55 (1.8%)		0/75 (0%)
depression	0/55 (0%)		1/75 (1.3%)
Respiratory, thoracic and mediastinal disorders
cough	3/55 (5.5%)		0/75 (0%)
Vascular disorders
hypertension	1/55 (1.8%)		3/75 (4%)

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.