Trial Outcomes & Findings for Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions (NCT NCT00553787)

NCT ID: NCT00553787

Last Updated: 2012-09-10

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2487 participants

Primary outcome timeframe

Baseline to 56 weeks

Results posted on

2012-09-10

Participant Flow

Subject recruitment occurred at investigative sites in the US between November 2007 through May 2008

Participant milestones

Participant milestones
Measure	Placebo	VI-0521 Mid 7.5 mg/46 mg phentermine/topiramate	VI-0521 Top 15 mg/92 mg phentermine/topiramate
Overall Study STARTED	994	498	995
Overall Study COMPLETED	616	374	733
Overall Study NOT COMPLETED	378	124	262

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo	VI-0521 Mid 7.5 mg/46 mg phentermine/topiramate	VI-0521 Top 15 mg/92 mg phentermine/topiramate
Overall Study Requirement for restricted medication	8	7	5
Overall Study Other	18	10	13
Overall Study Adverse Event	34	21	67
Overall Study Lost to Follow-up	132	44	78
Overall Study Withdrawal by Subject	151	40	83
Overall Study Lack of Efficacy	31	1	3
Overall Study Pregnancy	0	1	2
Overall Study non compliance	4	0	11

Baseline Characteristics

Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=994 Participants	VI-0521 Mid n=498 Participants 7.5 mg/46 mg phentermine/topiramate	VI-0521 Top n=995 Participants 15 mg/92 mg phentermine/topiramate	Total n=2487 Participants Total of all reporting groups
Age Continuous	51.2 years STANDARD_DEVIATION 10.3 • n=93 Participants	51.1 years STANDARD_DEVIATION 10.4 • n=4 Participants	51 years STANDARD_DEVIATION 10.7 • n=27 Participants	51.1 years STANDARD_DEVIATION 10.4 • n=483 Participants
Sex: Female, Male Female	695 Participants n=93 Participants	349 Participants n=4 Participants	693 Participants n=27 Participants	1737 Participants n=483 Participants
Sex: Female, Male Male	299 Participants n=93 Participants	149 Participants n=4 Participants	302 Participants n=27 Participants	750 Participants n=483 Participants
Region of Enrollment United States	994 participants n=93 Participants	498 participants n=4 Participants	995 participants n=27 Participants	2487 participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline to 56 weeks

Population: intent-to-treat last-observation-carried-forward (ITT-LOCF)

Outcome measures

Outcome measures
Measure	Placebo n=979 Participants	VI-0521 Mid n=488 Participants 7.5 mg/46 mg phentermine/topiramate	VI-0521 Top n=981 Participants 15 mg/92 mg phentermine/topiramate
Percent Weight Loss From Baseline to Week 56	1.24 percent weight loss Standard Error 0.277	7.81 percent weight loss Standard Error 0.365	9.84 percent weight loss Standard Error 0.275

PRIMARY outcome

Timeframe: Baseline to 56 weeks

Population: intent-to-treat last-observation-carried-forward (ITT-LOCF)

Outcome measures

Outcome measures
Measure	Placebo n=979 Participants	VI-0521 Mid n=488 Participants 7.5 mg/46 mg phentermine/topiramate	VI-0521 Top n=981 Participants 15 mg/92 mg phentermine/topiramate
Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF	20.8 percentage of participants	62.1 percentage of participants	70 percentage of participants

Adverse Events

Placebo

Serious events: 40 serious events

Other events: 761 other events

Deaths: 0 deaths

VI-0521 Mid

Serious events: 15 serious events

Other events: 424 other events

Deaths: 0 deaths

VI-0521 Top

Serious events: 50 serious events

Other events: 874 other events

Deaths: 0 deaths

Serious adverse events

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	Placebo n=993 participants at risk	VI-0521 Mid n=498 participants at risk 7.5 mg/46 mg phentermine/topiramate	VI-0521 Top n=994 participants at risk 15 mg/92 mg phentermine/topiramate
Infections and infestations Upper Respiratory Tract Infection	12.9% 128/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	12.2% 61/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	13.4% 133/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Infections and infestations Nasopharyngitis	8.7% 86/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	10.6% 53/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	9.9% 98/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Infections and infestations sinusitis	6.7% 67/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	6.8% 34/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	8.6% 85/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Infections and infestations bronchitis	4.3% 43/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	4.4% 22/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.2% 52/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Infections and infestations urinary tract infection	3.7% 37/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.2% 26/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.4% 54/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Gastrointestinal disorders constipation	5.9% 59/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	15.1% 75/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	17.4% 173/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Gastrointestinal disorders dry mouth	2.4% 24/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	13.5% 67/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	20.8% 207/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Gastrointestinal disorders nausea	4.2% 42/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	3.6% 18/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	6.8% 68/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Gastrointestinal disorders diarrhea	4.8% 48/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	6.4% 32/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.8% 58/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Nervous system disorders headache	9.1% 90/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	7.0% 35/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	10.2% 101/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Nervous system disorders paresthesia	2.0% 20/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	13.7% 68/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	20.5% 204/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Nervous system disorders dizziness	3.1% 31/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	7.2% 36/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	10.0% 99/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Nervous system disorders dysgeusia	1.1% 11/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	7.4% 37/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	10.4% 103/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Musculoskeletal and connective tissue disorders back pain	4.9% 49/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.6% 28/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	7.2% 72/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Musculoskeletal and connective tissue disorders arthralgia	5.4% 54/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	4.6% 23/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	4.4% 44/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
Psychiatric disorders insomnia	4.7% 47/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	5.8% 29/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	10.3% 102/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.
General disorders fatigue	5.0% 50/993 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	4.4% 22/498 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.	6.7% 67/994 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product. Only subjects who received at least one dose of study drug were included in the safety analysis.