Effects of the microsomal triglyceride transfer protein (MTP) inhibitor JNJ-16269110 on glycemic control and body weight in subjects with type 2 diabetes mellitus (T2DM) on metformin

• Introduction: JNJ-16269110 is a novel enterocyte-targeted MTP inhibitor acting via enterically-mediated hormonal and neural mechanisms being investigated for treatment of obesity. Methods: Three hundred and fifty two subjects with T2DM (BMI 32.8 kg/m2; 54% males) were randomized to placebo, JNJ-16269110 5-mg bid, 10-mg bid or 15-mg bid for 12 weeks in a double-blind multicenter clinical trial to assess safety and efficacy of this agent. The primary efficacy endpoint was change from baseline to Week 12 in HbA1c (ITT-mixed-model). Secondary endpoints included changes in fasting plasma glucose (FPG), body weight (BW), and plasma lipids. Results: Gastrointestinal symptoms were the most common reason for early discontinuation in the JNJ-16269110 arms (2%, 12%, 9% of subjects in 5-mg, 10-mg, 15-mg bid groups, respectively, vs. 1% in placebo group). Conclusion: Compared to placebo, JNJ-16269110 10-mg and 15-mg bid improved glycemic control and reduced BW. The most common side effects were related to the astrointestinal system. Conflict of interest: K. Stenlof received funding from Johnson and Johnson as principal investigator and consultant. E. Wajs, F. Vercruysse, D. Ways, S. Ouwerkerk-Mahadevan, J. Penson, and L. Van Nueten are employees and shareholders of Johnson and Johnson. Funding: The study was funded by Johnson & Johnson Pharmaceutical Research and Development.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)

Publikations- och innehållstyp

ref (ämneskategori)

kon (ämneskategori)