Hollander 2013 (COR-Diabetes): naltrexone-bupropion in type 2 diabetes

What they tested

505 overweight or obese adults with type 2 diabetes had a standard lifestyle program and were randomly assigned, 2 to 1, to sustained-release naltrexone 32 mg plus sustained-release bupropion 360 mg, or to placebo, for 56 weeks. Some were also taking diabetes pills.

In the group used for the main analysis, 54% were women, 80% were white, and on average people were 54 years old, weighed 106 kg and had an HbA1c of 8.0%. The main measures were percentage weight change and the share who lost at least 5% of their weight.

What they found

Weight fell 5.0% on naltrexone-bupropion and 1.8% on placebo. 44.5% of people on the drug lost at least 5% of their weight, against 18.9% on placebo.

HbA1c fell by 0.6% on the drug and 0.1% on placebo, and 44.1% against 26.3% reached an HbA1c below 7%. Triglycerides and HDL cholesterol also improved more on the drug.

Side effects were more common on the drug: nausea in 42.3% against 7.1%, constipation in 17.7% against 7.1%, and vomiting in 18.3% against 3.6%.

Rates of depression, suicidal thoughts and low blood sugar did not differ between the groups.

Limits

• Results are for a modified intent-to-treat group rather than simply everyone who was randomized.
• Most participants (80%) were white.
• Everyone also had a lifestyle program, so the results apply to the drug used alongside one.

What it means if you're considering naltrexone

This trial is about the weight-loss combination in people with type 2 diabetes, not about naltrexone tablets for drinking. It found the combination improved both weight and blood sugar control in this group, with stomach side effects as the main cost. It doesn't apply to the 50 mg naltrexone tablets used for alcohol.