Trial Outcomes & Findings for Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics (NCT NCT00486291)

NCT ID: NCT00486291

Last Updated: 2012-09-10

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

210 participants

Primary outcome timeframe

Baseline to 28 weeks

Results posted on

2012-09-10

Participant Flow

Subject recruitment occurred in 10 investigative sites in the U.S. between May 2007 and July 2007

Participant milestones

Participant milestones
Measure	Active Phentermine 15mg/topiramate 100mg	Placebo Matched placebo
Overall Study STARTED	105	105
Overall Study COMPLETED	89	76
Overall Study NOT COMPLETED	16	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Phentermine 15mg/topiramate 100mg	Placebo Matched placebo
Overall Study Adverse Event	3	4
Overall Study Lost to Follow-up	3	7
Overall Study protocol non-compliance	10	15
Overall Study requirement for restricted medication	0	3

Baseline Characteristics

Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=102 Participants Phentermine 15mg/topiramate 100mg	Placebo n=104 Participants Matched placebo	Total n=206 Participants Total of all reporting groups
Age Continuous	50.2 years STANDARD_DEVIATION 8.39 • n=5 Participants	48.5 years STANDARD_DEVIATION 9.72 • n=7 Participants	49.4 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants	64 Participants n=7 Participants	141 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	40 Participants n=7 Participants	65 Participants n=5 Participants
Region of Enrollment United States	102 participants n=5 Participants	104 participants n=7 Participants	206 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 28 weeks

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

Outcome measures

Outcome measures
Measure	Active n=99 Participants Phentermine 15mg and topiramate 100mg	Placebo n=101 Participants Matched placebo
Change From Baseline in HbA1c at Week 28.	-1.1 percent change Standard Error 0.12	-0.6 percent change Standard Error 0.11

SECONDARY outcome

Timeframe: Baseline to 28 weeks

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

Outcome measures

Outcome measures
Measure	Active n=99 Participants Phentermine 15mg and topiramate 100mg	Placebo n=101 Participants Matched placebo
Absolute Weight Change (kg) From Baseline to Week 28	-7.7 kg Standard Error 0.57	-1.3 kg Standard Error 0.57

Adverse Events

Active

Serious events: 5 serious events

Other events: 85 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 86 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active n=102 participants at risk Phentermine 15mg/topiramate 100mg	Placebo n=104 participants at risk Matched placebo
Neoplasms benign, malignant and unspecified (incl cysts and polyps) colon cancer	0.00% 0/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.96% 1/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) colon cancer metastatic	0.98% 1/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Blood and lymphatic system disorders anemia	0.98% 1/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Cardiac disorders cardiac arrest	0.00% 0/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.96% 1/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Cardiac disorders cardiac failure congestive	0.00% 0/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.9% 2/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
General disorders non-cardiac chest pain	0.00% 0/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.96% 1/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Hepatobiliary disorders cholelithiasis	0.98% 1/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Infections and infestations viral infection	0.98% 1/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Musculoskeletal and connective tissue disorders osteoarthritis	0.98% 1/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders thalamic infarction	0.00% 0/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.96% 1/104 • 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	Active n=102 participants at risk Phentermine 15mg/topiramate 100mg	Placebo n=104 participants at risk Matched placebo
Infections and infestations upper respiratory tract infection	12.7% 13/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	18.3% 19/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Infections and infestations influenza	7.8% 8/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	2.9% 3/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Infections and infestations nasopharyngitis	4.9% 5/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	4.8% 5/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Infections and infestations bronchitis	4.9% 5/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	2.9% 3/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders nausea	17.6% 18/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	4.8% 5/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders diarrhea	10.8% 11/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	5.8% 6/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders constipation	9.8% 10/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.9% 2/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders dry mouth	7.8% 8/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.96% 1/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders vomiting	4.9% 5/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	3.8% 4/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders gastroesophageal reflux disease	6.9% 7/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.96% 1/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders paresthesia	17.6% 18/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders dizziness	7.8% 8/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.96% 1/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders headache	4.9% 5/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	2.9% 3/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders hypoesthesia	4.9% 5/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.9% 2/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Musculoskeletal and connective tissue disorders arthralgia	4.9% 5/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	4.8% 5/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Musculoskeletal and connective tissue disorders back pain	3.9% 4/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	4.8% 5/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
General disorders fatigue	4.9% 5/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	2.9% 3/104 • 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	5.9% 6/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	4.8% 5/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Metabolism and nutrition disorders hypokalemia	5.9% 6/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.96% 1/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Psychiatric disorders insomnia	8.8% 9/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	3.8% 4/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Psychiatric disorders anxiety	6.9% 7/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	3.8% 4/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Eye disorders vision blurred	2.9% 3/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	4.8% 5/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Vascular disorders hypertension	0.00% 0/102 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	4.8% 5/104 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.