Phase 2
Completed N=210
Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics
Source: ClinicalTrials.gov NCT00486291 ↗Enrolled (actual)
210
Serious AEs
5.3%
Results posted
Sep 2012
Primary outcomePrimary: Change From Baseline in HbA1c at Week 28. — -1.1; -0.6 percent change — p=0.0007
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 28. |
-1.1; -0.6 | 0.0007 sig |
| SECONDARY Absolute Weight Change (kg) From Baseline to Week 28 |
-7.7; -1.3 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00486291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.