This article is part of Endocrinology Advisor’s coverage of the American Diabetes Association’s 77th Scientific Sessions (ADA 2017), taking place in San Diego, CA. Our staff will report on medical research and technological advances in diabetes and diabetes education, conducted by experts in the field. Check back regularly for more news from ADA 2017.
Hypogonadal men with type 2 diabetes (T2D) who were treated with testosterone undecanoate (TU) injections demonstrated reductions in glycated hemoglobin A1c (HbA1c) and anthropometric measures, according to data presented at the 77th American Diabetes Association Scientific Sessions, June 9-13, in San Diego.
“As recommended by the [American Association of Clinical Endocrinologists]/[American College of Endocrinology] guidelines for the management of obesity, it is worthwhile measuring testosterone in men with T2D, especially if they are obese,” study researcher Farid Saad, PhD, with Bayer AG, Berlin, said in an interview with Endocrinology Advisor. “Correcting hypogonadism by testosterone therapy will result in major improvements of the diabetic state, provided that treatment is performed long enough (ie, for life) and is adequate (ie, testosterone levels achieved are high enough).”
According to Dr Saad, the registry study was initiated in 2004 to study effectiveness and safety of a new testosterone preparation that had become available in Germany that year.
“This preparation is a 3-monthly injection [of TU] requiring only 4 injections per year,” Dr Saad said. “Injections have to be administered in the office and are always documented. This is why we know that there was a 100% adherence.”
In all, the study included 321 men with hypogonadism in a urological setting. Of these men, 94 (29.3%) had T2D and were treated with the TU injections for up to 12 years. Family physicians treated the patients’ T2D.
Due to reimbursement issues, roughly 50% of patients experienced temporary interruptions of TU treatment for a mean of 17 months.
Researchers examined anthropometric and metabolic parameters at every or every other visit.
Mean patient age was 60.1±8 years and HbA1c was poorly controlled (7.9±1%).
At 12 years, HbA1c decreased to 5.5±0.3%, which resulted in a statistically significant change vs baseline each year (P <.0001).
Results obtained during the final observation revealed that 90.4% of patients were within an HbA1c target of <7%, and 78.7% were within an HbA1c target of <6.5%.
In addition, the following metrics were also reduced from baseline: fasting glucose (4.6±0.7 vs 7.81±2.3 mmol/L; P <.0001); weight (86.6±6.9 vs 107.8±13.2 kg); waist circumference (94.5±2.7 vs 114±10.7 cm); and body mass index (27.3±2.2 vs 34.1±4.1 kg/m2).
All improvements in anthropometric measures were statistically significant when compared with baseline (P <.0001).
Dr Saad said that he and his colleagues were initially surprised when they realized patients were losing weight in a progressive and sustained manner, because that had never before been documented in literature.
“In our urological setting, we usually do not focus on weight loss in obese patients, and no detailed instructions for lifestyle modification had been provided to our patients,” he said. “Expectations had been that patients’ sexual function, mood, and energy would improve, which is what happened.”
Dr Saad added that for men with hypogonadism and obesity as well as type 2 diabetes, adequate testosterone therapy may be the most beneficial treatment possible.
“The unique effect of testosterone is that it invariably increases lean body mass, which helps normalize metabolism,” he said. “This cannot be achieved with any other drug.”
Disclosures: All 3 researchers report financial relationships with Bayer AG.
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Saad F, Doros G, Yassin A. Most hypogonadal men with type 2 diabetes mellitus (T2DM) achieve HbA1c targets when treated with testosterone undecanoate (TU) injections for up to 12 Years. Poster 1144-P. Presented at: the 77th American Diabetes Association Scientific Sessions. June 9-13, 2017; San Diego, California.