Phase 3
N=796
Extended Niacin/Laropiprant in Patients With Type 2 Diabetes (0524A-069)
Diabetes Mellitus Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00485758 ↗Enrolled (actual)
796
Serious AEs
6.3%
Results posted
Sep 2009
Primary outcome: Primary: Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo — -15.8; 2.1 Percent change at Wk 12 compared to Bl — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ER niacin/laropiprant (Drug); Comparator : placebo (unspecified) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo |
-15.8; 2.1 | <0.001 sig |
| SECONDARY Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo |
25.4; 2.2 | <0.001 sig |
| SECONDARY Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Triglycerides in Patients With Type 2 Diabetes When Compared to Placebo |
-22.2; 2.3 | <0.001 sig |
Summary
A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant versus placebo in Type 2 Diabetes Mellitus patients.
Eligibility Criteria
Inclusion Criteria
- Patients between the ages of 18 to 80 years with Type 2 Diabetes who are on a stable dose of antidiabetic medication for at least 3 months
Exclusion Criteria
- Patients taking Cholestin, niacin (>50 mg/day), fibrate therapy, hormonal contraceptives, intermittent Hormone Replacement Therapy, or certain corticosteroids
- Patients with any of the following conditions: active liver disease or kidney disease, poorly controlled high blood pressure, active peptic ulcer, or other heart or blood diseases
- Patients with abnormal laboratory results from a blood test that will be given before starting the study
Data sourced from ClinicalTrials.gov (NCT00485758). 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.