Diabetes
Conditions
Keywords
Diabetes, Type 2 Diabetes, Diabetes Mellitus, Metabolic Diseases, Glucose Metabolism Disorders, Glycemic Control
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.
Interventions
phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks
DRUGPlacebo
Oral placebo capsules, once daily, 28 weeks
Sponsors
Synteract, Inc.
Sentrx
VIVUS LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c Change From Baseline Week 0 to Week 56 | Baseline to 56 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent Weight Loss From Baseline to Week 56 | Baseline to 56 weeks |
Countries
United States
Participant flow
Recruitment details
Subject recruitment occurred in 10 investigative sites in the U.S. between January 2008 and October 2008
Participants by arm
| Arm | Count |
|---|---|
| Placebo | 55 |
| Active PHEN/TPM 15/92 | 75 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | protocol non-compliance | 0 | 3 |
Baseline characteristics
| Characteristic | Placebo | Active | Total |
|---|---|---|---|
| Age Continuous | 49.5 years STANDARD_DEVIATION 8.58 | 49.7 years STANDARD_DEVIATION 7.51 | 49.6 years STANDARD_DEVIATION 7.95 |
| Region of Enrollment United States | 55 participants | 75 participants | 130 participants |
| Sex: Female, Male Female | 32 Participants | 58 Participants | 90 Participants |
| Sex: Female, Male Male | 23 Participants | 17 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 55 | 48 / 75 |
| serious Total, serious adverse events | 1 / 55 | 2 / 75 |
Outcome results
Primary
HbA1c Change From Baseline Week 0 to Week 56
Time frame: Baseline to 56 weeks
Population: Intent-to-treat Last-observation-carried-forward (ITT-LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | HbA1c Change From Baseline Week 0 to Week 56 | -1.2 percent change | Standard Error 0.13 |
| VI-0521 | HbA1c Change From Baseline Week 0 to Week 56 | -1.56 percent change | Standard Error 0.11 |
p-value: 0.038195% CI: [-0.69, -0.02]ANCOVA
Secondary
Percent Weight Loss From Baseline to Week 56
Time frame: Baseline to 56 weeks
Population: Intent-to-treat Last-observation-carried-forward (ITT-LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Weight Loss From Baseline to Week 56 | -2.71 percent change | Standard Error 0.95 |
| VI-0521 | Percent Weight Loss From Baseline to Week 56 | -9.41 percent change | Standard Error 0.81 |
p-value: <0.000195% CI: [-9.18, -4.21]ANCOVA