COR-Diabetes

In COR-Diabetes, HbA1C reductions were seen when patients with type 2 diabetes lost weight with Mysimba® (mITT-LOCF).1

Mysimba® significantly improved HbA1C 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 HbA1C 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 HbA1C: Mysimba®: 8.0%; placebo: 8.0%.1

 

Mysimba® ITT: n=321, placebo ITT: n=166. Average baseline parameters were: Mysimba®: 104.2 kg, placebo: 105.3 kg. Patients who completed 56 weeks of treatment: Mysimba®: 52.2%; placebo: 58.8%.1,2

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References:

  1. Mysimba® SmPC available at https://www.medicines.org.uk/emc/product/2684/smpc#gref accessed September 2026
  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.
Reporting adverse effects: Adverse effects should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. Alternatively you can report a suspected adverse drug reaction to the Yellow Card scheme by calling 0800 731 6789 Adverse events should also be reported to Orexigen®: +44 20 3966 0116 or currax.mi@primevigilance.com.
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.

MYS 014
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.

MYS 014
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.

MYS 014