Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes, Obese diabetics
Brief summary
The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults.
Interventions
DRUGPlacebo
matched placebo
DRUGVI-0521
phentermine 15mg/topiramate 100mg
Sponsors
Synteract, Inc.
VIVUS LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent * Type 2 Diabetes * BMI 27-42 * Specified diet/exercise and/or diabetes medications
Exclusion criteria
* BP \> 150/95 * Stroke/MI/unstable cardiovascular disease within 6 months * Clinically significant renal, hepatic, or psychiatric disease * Unstable thyroid disease or replacement therapy * Nephrolithiasis * Obesity of known genetic or endocrine origin * Participation in a formal weight loss program or lifestyle intervention * History of glaucoma * Pregnancy or breastfeeding * Alcohol abuse * Eating disorder * Excluded medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in HbA1c at Week 28. | Baseline to 28 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Absolute Weight Change (kg) From Baseline to Week 28 | Baseline to 28 weeks |
Countries
United States
Participant flow
Recruitment details
Subject recruitment occurred in 10 investigative sites in the U.S. between May 2007 and July 2007
Participants by arm
| Arm | Count |
|---|---|
| Active Phentermine 15mg/topiramate 100mg | 102 |
| Placebo Matched placebo | 104 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Active | Placebo | Total |
|---|---|---|---|
| Age Continuous | 50.2 years STANDARD_DEVIATION 8.39 | 48.5 years STANDARD_DEVIATION 9.72 | 49.4 years STANDARD_DEVIATION 9.1 |
| Region of Enrollment United States | 102 participants | 104 participants | 206 participants |
| Sex: Female, Male Female | 77 Participants | 64 Participants | 141 Participants |
| Sex: Female, Male Male | 25 Participants | 40 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 85 / 102 | 86 / 104 |
| serious Total, serious adverse events | 5 / 102 | 6 / 104 |
Outcome results
Primary
Change From Baseline in HbA1c at Week 28.
Time frame: Baseline to 28 weeks
Population: Intent-to-treat Last-observation-carried-forward (ITT-LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Active | Change From Baseline in HbA1c at Week 28. | -1.1 percent change | Standard Error 0.12 |
| Placebo | Change From Baseline in HbA1c at Week 28. | -0.6 percent change | Standard Error 0.11 |
Comparison: It is anticipated that the pooled standard deviation (SD) of the change from baseline in HbA1c will be between 1.0 and 1.5. With 90 subjects per treatment group the study will have 90% power (two-sided alpha=0.05) to detect a mean difference between groups of 0.486 for SD=1.0, and a mean difference between groups of 0.729 for SD=1.5.p-value: 0.000795% CI: [-0.9, -0.2]ANCOVA
Secondary
Absolute Weight Change (kg) From Baseline to Week 28
Time frame: Baseline to 28 weeks
Population: Intent-to-treat Last-observation-carried-forward (ITT-LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Active | Absolute Weight Change (kg) From Baseline to Week 28 | -7.7 kg | Standard Error 0.57 |
| Placebo | Absolute Weight Change (kg) From Baseline to Week 28 | -1.3 kg | Standard Error 0.57 |
p-value: <0.000195% CI: [-8.1, -4.9]ANCOVA