COR-Diabetes

In COR-Diabetes, A1c reductions were seen when patients with type 2 diabetes lost weight with Mysimba® (mITT-LOCF).1

Mysimba® significantly improved A1c in patients with type 2 diabetes1

  • Significantly more patients achieved ≥5% weight loss with Mysimba® (28%) vs placebo (14%) at 56 weeks (P<0.001; ITT-BOCF analysis)1
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  • Patients lost significantly more weight with Mysimba® (-3.7%) vs placebo (-1.7%) at 56 weeks (P<0.001; ITT-LOCF analysis)1
 

Mysimba® is not indicated for the treatment of diabetes.

A bar chart that shows the mean A1c reduction at Week 56 from the COR-Diabetes clinical study. The axis of the chart is vertical and the bars are purple and grey.

Intention-To-Treat; LOCF=last observation carried forward; BOCF=baseline observation carried forward; COR=Contrave obesity research; mITT=modified Intention-To-Treat based on LOCF with the last on-drug observation carried forward.

COR-Diabetes was a 56-week, multicentre, double-blind, placebo-controlled study. Overweight or obese patients (BMI ≥27 kg/m2) with type 2 diabetes with or without hypertension and/or dyslipidemia were randomised to Mysimba® 32 mg/360 mg daily or placebo. COR-Diabetes evaluated patients with type 2 diabetes not achieving glycemic goal of an HbA1c <7% either with oral antidiabetic agents or with diet and exercise alone. The co-primary endpoints were percent change from baseline body weight and the proportion of patients achieving ≥5% reduction in body weight at Week 56. LOCF was used for missing data. Mean baseline A1c: Mysimba®: 8.0%; placebo: 8.0%.1

 

Mysimba® ITT: n=321, placebo ITT: n=166. Average baseline parameters were: Mysimba®: 104.2 kg, 115.6-cm waist circumference; placebo: 105.3 kg, 114.3-cm waist circumference. Patients who completed 56 weeks of treatment: Mysimba®: 52.2%; placebo: 58.8%.1,3

View safety profile
Important Safety Information

Please refer to the Mysimba® Summary of Product Characteristics (SmPC)


▼ Black Triangle

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Important Safety Information

Please refer to the Mysimba® Summary of Product Characteristics (SmPC)


▼ Black Triangle

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Important Safety Information

Please refer to the Mysimba® Summary of Product Characteristics (SmPC)


▼ Black Triangle

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

References:

  1. Mysimba® (naltrexone HCl and bupropion HCl) Summary of Product Characteristics (SmPC).
  2. Hollander P, Gupta AK, Plodkowski R, et al. Effects of naltrexone sustained- release/bupropion sustained-release combination therapy on body weight and glycemic parameters in overweight and obese patients with type 2 diabetes. Diabetes Care. 2013;36(12):4022–4029. 3. Data on file.