Prevalence and Characteristics of Low Serum Testosterone Levels in Men with Type 2 Diabetes Mellitus Naïve to Injectable Therapy
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1 Prevalence and Characteristics of Low Serum Testosterone Levels in Men with Type 2 Diabetes Mellitus Naïve to Injectable Therapy International Society for Sexual Medicine 2014 Presenter: Felipe Borges Dos Reis Author(s): Paula Polzer, Xiao Ni
2 Disclosure Medical advisor at Eli Lilly 2
3 Background Male hypogonadism is defined by low serum testosterone (T) levels and associated clinical symptoms Prevalence is higher among men with type 2 diabetes mellitus (T2DM) The Endocrine Society, and other relevant international societies, recommend assessment of testosterone levels in men with T2DM. 3
4 Objective To assess the prevalence of a low testosterone level and its association with other baseline characteristics in men with T2DM in a phase 3 randomized clinical trial of the once weekly GLP-1 receptor agonist dulaglutide versus metformin. 4
5 Methods This was a post hoc analysis of baseline data from participants enrolled in a phase 3, randomized, double-blind, parallel-arm, active comparator, 52-week study designed to assess the safety and efficacy of dulaglutide. 5
6 Methods: Inclusion and exclusion criteria Key Inclusion Criteria: Type 2 diabetes for 3 months and 5 years Screening HbA1c 6.5% to 9.5% Treatment naïve; not optimally controlled with diet + exercise alone; OR receiving 1 oral antihyperglycemic at 50% of max recommended daily dose for 3 months Stable weight (±5%) for 3 months prior to screening BMI 23 to 45kg/m 2, inclusive Only male participants evaluated in the present analysis, men receiving T replacement (n=3) were excluded from analysis Key Exclusion Criteria: Type 1 diabetes mellitus Prior chronic use of insulin Use of glucagon like peptide 1 receptor agonist within 3 months of study entry Within 2 months prior to study entry: acute myocardial infarction, New York Heart Association (NYHA) class IV heart failure, or cerebrovascular accident Received chronic ( 14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, or inhaled preparations) within 4 weeks prior to screening 6
7 Methods: Measures and statistical analysis Low total T (TT) defined as <300 ng/dl or a previous diagnosis of hypogonadism. Serum T levels testing performed using Liquid Chromatography-Mass Spectrometry Low Free T (FT) defined as <65 pg/ml. FT calculated using the Vermeulen equation (de Ronde et al) based on serum albumin collected at screening, and TT and SHBG collected at baseline A two-sample t-test and Fisher s exact test were used to compare testosterone subgroups for continuous and categorical variables, respectively. Pearson s correlation coefficients were calculated between T levels and continuous variables. Findings were considered statistically significance at p<0.05. de Ronde et al. (2006) Clin Chem;52:
8 Results: Distribution of baseline total testosterone measurements Percent Total Testosterone at Baseline (ng/dl) 8
9 Results: Distribution of baseline calculated free testosterone values Percent Free Testosterone at Baseline (pg/ml) 9
10 Results: Baseline characteristics by low vs. normal total or free testosterone levels Total Testosterone (TT) Free Testosterone (FT) Variable Low TT (N=101) Normal TT (N=211) P-value Low FT (N=85) Normal FT (N=209) P-value Age (years), mean (SD) 56.7 (8.5) 56.0 (10.4) (8.9) 55.1 (9.7) <0.001 Age 65 years, n (%) 19 (18.8) 39 (18.5) (29.4) 31 (14.8) Race (%) White 81 (80.2) 151 (71.6) 72 (84.7) 158 (75.6) Black/African-American 6 (5.9) 13 (6.2) 7 (8.2) 12 (5.7) Asian 7 (6.9) 22 (10.4) 2 (2.4) 11 (5.3) American Indian/Alaska native 7 (6.9) 23 (10.9) 4 (4.7) 26 (12.4) BMI (kg/m 2 ), mean (SD) 34.6 (5.3) 30.8 (4.6) < (4.7) 31.4 (5.0) <0.001 Weight (kg), mean (SD) (21.0) 92.7 (16.1) < (18.4) 95.0 (17.1) <0.001 HbA1c (%) 7.63 (0.92) 7.62 (0.89) (0.87) 7.62 (0.89) %, n (%) 36 (35.6) 64 (30.3) (35.3) 69 (33.0) 0.79 HOMA2-%B, mean (SD) 75.4 (38.4) 73.6 (39.1) (39.7) 73.2 (38.9) 0.75 HOMA2-%S, mean (SD) 40.8 (20.7) 52.8 (33.3) (21.3) 51.1 (32.3) Low TT = TT<300ng/dL; normal TT=TT 300 ng/dl; Low FT=FT<65pg/mL; normal FT=FT 65pg/mL; HbA1c=hemoglobin A1c; HOMA2=homeostatic model assessment 2; %B=beta-cell function [c-peptide based]; %S=insulin sensitivity [insulin based] 10
11 Results: Baseline Diabetes Symptom Checklist (revised version) scores by low vs. normal total testosterone and free testosterone levels Total Testosterone Free Testosterone Variable Low TT (N=101) Normal TT (N=211) P- value Low FT (N=85) Normal FT (N=209) P-value DSC-r Psychology: Fatigue, mean (SD) 1.28 (1.22) 1.10 (1.09) (1.23) 1.12 (1.0) 0.34 DSC-r: Lack of Energy, N (%) yes 53 (52.5) 96 (45.7) (51.8) 98 (47.1) 0.52 Yes, mean (SD) 2.72 (0.91) 2.35 (0.79) (0.92) 2.38 ( DSC-r: Overall Fatigue, N (%) yes 55 (54.5) 101 (48.1) (60.0) 100 (48.1) Yes, mean (SD) 2.62 (0.97) 2.41 (0.89) (0.90) 2.43 (0.93) 0.53 DSC-r: Increasing Fatigue, N (%) yes 46 (45.5) 103 (49.0) (48.2) 103 (49.5) 0.90 Yes, mean (SD) 2.65 (1.08) 2.39 (0.87) (1.00) 2.43 (0.94) 0.67 DSC-r: Morning Fatigue N (%) yes 42 (41.6) 94 (44.8) (44.7) 91 (43.8) 0.90 Yes, mean (SD) 2.52 (0.99) 2.26 (0.95) (0.95) 2.26 (0.96) 0.53 DSC-r Psychology: Cognitive, mean (SD)* 0.79 (0.88) 0.80 (0.91) (0.91) 0.79 (0.90) 0.97 For both TT and FT, no significant differences were seen between groups for the DSC-r Cognitive items Sleepy/Drowsy, Difficulty concentrating, Fuzzy-headed feeling, and Difficulty paying attention (all p 0.287, data not shown). 11
12 Results: Baseline comorbid conditions or medication use by low versus normal total testosterone and free testosterone levels Total Testosterone Free Testosterone Variable, n (% yes) Low TT (N=101) Normal TT (N=211) P-value Low FT (N=85) Normal FT (N=209) P-value LUTS/BPH 9 (8.9) 8 (3.8) (10.6) 8 (3.8) Cardiovascular 18 (17.8) 23 (10.9) (16.5) 27 (12.9) 0.50 Dyslipidemia 63 (62.4) 100 (47.4) (64.7) 105 (50.2) Depression 10 (9.9) 13 (6.2) (10.6) 14 (6.7) 0.34 Erectile dysfunction 11 (10.9) 9 (4.3) (11.8) 9 (4.3) PDE5i 3 (3.0) 2 (0.9) (3.5) 2 (1.0) 0.15 Statin 53 (52.5) 59 (28.0) < (48.2) 68 (32.5) Non-statin lipid lowering medication (LLM) 9 (8.9) 24 (11.4) (11.8) 23 (11.0) 0.84 Low TT = total testosterone <300 ng/dl; normal TT = TT 300ng/dL; Low FT = low free testosterone <65 pg/ml; normal FT = free testosterone 65 pg/ml; LUTS/BPH= lower urinary tract symptoms suggestive of benign prostatic hyperplasia; PDE5i= phosphodiesterase type 5 inhibitor 12
13 Results: Correlations with total or free testosterone levels Variable, Total Testosterone (N=312) Free Testosterone (N=294) N Corr Coeff. P N Corr Coeff. P Age <0.001 BMI < <0.001 Weight < <0.001 HbA1c HOMA2-%B (insulin) HOMA2-%S < Free Testosterone <0.001 Variable Total T (N=312) Free T (N=294) N Corr Coeff. P N Corr Coeff. P DSC-r Psychology, Fatigue Lack of Energy (yes) Overall Fatigue (yes) Increasing Fatigue (yes) Morning Fatigue (yes) DSC-r Psychology, Cognitive Sleepy/Drowsy (yes) Difficulty Concentrating (yes) Fuzzy-headed feeling (yes) Difficulty paying attention (yes) HbA1c = hemoglobin A1c; HOMA2= homeostatic model assessment 2; %B= beta-cell function [c-peptide based]; %S= insulin sensitivity [insulin based]; Diabetes Symptom Checklist (revised version) 13
14 Conclusions In a population of men with T2DM naïve to injectable therapy, approximately one-third (n=101) had untreated low TT, and there were only 3 additional men receiving T replacement therapy. Men with low TT were of similar age and had comparable HbA1c to men with normal TT, but had higher weight and BMI, and reduced insulin sensitivity. Low T levels correlated with patient-reported lack of energy. These data support Endocrine Society Guidelines for measuring testosterone levels in men with T2DM. Further study is needed to evaluate the role of T replacement in T2DM. 14
15 References 1. Dandona and Dhindsa. (2011) J Clin Endocrinol Metab;96: Corona et al. (2011) Int J Androl;34: Grossmann et al. (2008) J Clin Endocrinol Metab;93: Bhasin et al. (2010) J Clin Endocrinol Metab;95: de Ronde et al. (2006) Clin Chem;52:
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PDL Class: Topical Androgens
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NCT00272090. sanofi-aventis HOE901_3507. insulin glargine
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: Generic drug name: