Trial Outcomes & Findings for A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults (NCT NCT00600067)

NCT ID: NCT00600067

Last Updated: 2012-09-10

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

130 participants

Primary outcome timeframe

Baseline to 56 weeks

Results posted on

2012-09-10

Participant Flow

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

Participant milestones

Participant milestones
Measure	Placebo	VI-0521 phentermine 15 mg/topiramate 92 mg
Overall Study STARTED	55	75
Overall Study COMPLETED	52	68
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo	VI-0521 phentermine 15 mg/topiramate 92 mg
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	2	3
Overall Study protocol non-compliance	0	3
Overall Study Lack of Efficacy	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=55 Participants	Active n=75 Participants PHEN/TPM 15/92	Total n=130 Participants Total of all reporting groups
Age Continuous	49.5 years STANDARD_DEVIATION 8.58 • n=5 Participants	49.7 years STANDARD_DEVIATION 7.51 • n=7 Participants	49.6 years STANDARD_DEVIATION 7.95 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	58 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	17 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants	75 participants n=7 Participants	130 participants n=5 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=55 Participants	VI-0521 n=75 Participants phentermine 15mg/topiramate 92 mg
HbA1c Change From Baseline Week 0 to Week 56	-1.2 percent change Standard Error 0.13	-1.56 percent change Standard Error 0.11

SECONDARY outcome

Timeframe: Baseline to 56 weeks

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

Outcome measures

Outcome measures
Measure	Placebo n=55 Participants	VI-0521 n=75 Participants phentermine 15mg/topiramate 92 mg
Percent Weight Loss From Baseline to Week 56	-2.71 percent change Standard Error 0.95	-9.41 percent change Standard Error 0.81

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

Active

Serious events: 2 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=55 participants at risk	Active n=75 participants at risk PHEN/TPM 15/92
Musculoskeletal and connective tissue disorders costochondritis	0.00% 0/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.3% 1/75 • 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 intervertebral disc protrusion	0.00% 0/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.3% 1/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Hepatobiliary disorders cholelithiasis	1.8% 1/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/75 • 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	Placebo n=55 participants at risk	Active n=75 participants at risk PHEN/TPM 15/92
Infections and infestations upper respiratory tract infection	14.5% 8/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	9.3% 7/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders constipation	1.8% 1/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	5.3% 4/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders paresthesia	0.00% 0/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	5.3% 4/75 • 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	5.5% 3/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	4.0% 3/75 • 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	9.1% 5/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	12.0% 9/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Metabolism and nutrition disorders diabetes mellitus	9.1% 5/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.3% 1/75 • 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 cough	5.5% 3/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Infections and infestations Influenza	0.00% 0/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	2.7% 2/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Infections and infestations nasopharyngitis	1.8% 1/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.3% 1/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Infections and infestations bronchitis	0.00% 0/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.3% 1/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Infections and infestations urinary tract infection	1.8% 1/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.3% 1/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Infections and infestations sinusitis	1.8% 1/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders diarrhea	3.6% 2/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders nausea	1.8% 1/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.3% 1/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders vomiting	0.00% 0/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.3% 1/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders abdominal pain	1.8% 1/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.3% 1/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders dizziness	1.8% 1/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.3% 1/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders headache	1.8% 1/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.3% 1/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders hypoesthesia	1.8% 1/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	2.7% 2/75 • 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 pain in extremity	3.6% 2/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.3% 1/75 • 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	1.8% 1/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.3% 1/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Psychiatric disorders insomnia	0.00% 0/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.3% 1/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Psychiatric disorders anxiety	1.8% 1/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
General disorders pyrexia	3.6% 2/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Eye disorders vision blurred	3.6% 2/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Vascular disorders hypertension	1.8% 1/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	4.0% 3/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Psychiatric disorders depression	0.00% 0/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	1.3% 1/75 • 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	0.00% 0/55 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	2.7% 2/75 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.