Phase 3 Completed N=796 Randomized Double-blind Treatment

Extended Niacin/Laropiprant in Patients With Type 2 Diabetes (0524A-069)

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT00485758 ↗

Enrolled (actual)

796

Serious AEs

6.3%

Results posted

Sep 2009

Primary outcomePrimary: 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

Summary

A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant versus placebo in Type 2 Diabetes Mellitus patients.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.