Object: We investigated whether dulaglutide (DU)-combined conventional insulin therapy is beneficial for glycemic control in noncritically ill hospitalized patients with type-2 diabetes.

Method: This study was a prospective, randomized-controlled pilot study. Participants were randomized to either basal-plus (BP) therapy, those receiving basal insulin and corrective doses of regular insulin before meals, or BP+DU therapy, those receiving BP therapy combined with DU. Blood glucose (BG) levels before and after every meal were measured for 7 days after assignment. Because we consider the ideal BG during hospitalization to be within 100-180 mg/dL, we define this range as the hospitalized ideal glucose range (hIGR). We compared the percentage of hIGR with all measured BGs (%hIGR), mean BG, glucose variability (GV), and insulin dose.

Result: Of 54 patients participating in the study, 27 were assigned to the BP group and 27 to the BP+DU group. The %hIGR was significantly higher and percentage of BG >240 and BG <70 was significantly lower in the BP+DU compared with the BP group. The mean BG, SD, coefficient of variation, and total regular insulin dose in the BP+DU group were significantly lower than those in the BP group (Table). No significant side effects were observed.

 BP group BP+DU group  
 n=974, N=27 n=899, N=27 P value 
Baseline characteristics    
Age, years 70.1±14 70.9±13 0.822 
Male, N (%) 18 (67) 15 (56) 0.577 
BMI, kg/m2 24.6±5.7 25.1±6.7 0.904 
Duration, years 10.1±8.8 8.7±9.4 0.488 
HbA1c, % 8.0±1.9 8.2±1.7 0.401 
Frequency of the measured BGs in each BG ranges, n (%)  
BG <70 21 (2.3) 4 (0.4) <0.001 
BG 71–99 63 (7) 99 (10) 0.019 
BG 100–180 (%hIGR) 399 (44) 545 (56) <0.001 
BG 181–240 232 (26) 244 (25) 0.748 
BG >240 184 (21) 82 (8) <0.001 
Daily BG profiles, mean±SD mg/dL   
Fasting 131±38 127±40 0.254 
After breakfast 244±61 196±54 0.004 
Before lunch 216±65 173±56 <0.001 
After lunch 195±62 182±54 0.041 
Before dinner 135±47 143±44 0.232 
After dinner 203±62 177±54 <0.001 
mean BG after first day 183±29 162±30 0.014 
Glucose variability, mean±SD    
Individual glucose SD during study 62.5±21 45.0±14 0.001 
Individual glucose CV during study 0.34±0.09 0.27±0.05 0.002 
Hypoglycemic event, N (%)    
Patients <70 mg/dL 9 (33) 3 (11) 0.099 
Insulin therapy, mean±SD U/day    
Total insulin 17.1±6.6 16.1±6.4 0.762 
Total glargine insulin 12.0±5.7 12.6±4.8 0.55 
Total regular insulin 5.4±2.5 3.6±2.8 0.017 
n, number of the measured BGs; N, number of the patients 
 BP group BP+DU group  
 n=974, N=27 n=899, N=27 P value 
Baseline characteristics    
Age, years 70.1±14 70.9±13 0.822 
Male, N (%) 18 (67) 15 (56) 0.577 
BMI, kg/m2 24.6±5.7 25.1±6.7 0.904 
Duration, years 10.1±8.8 8.7±9.4 0.488 
HbA1c, % 8.0±1.9 8.2±1.7 0.401 
Frequency of the measured BGs in each BG ranges, n (%)  
BG <70 21 (2.3) 4 (0.4) <0.001 
BG 71–99 63 (7) 99 (10) 0.019 
BG 100–180 (%hIGR) 399 (44) 545 (56) <0.001 
BG 181–240 232 (26) 244 (25) 0.748 
BG >240 184 (21) 82 (8) <0.001 
Daily BG profiles, mean±SD mg/dL   
Fasting 131±38 127±40 0.254 
After breakfast 244±61 196±54 0.004 
Before lunch 216±65 173±56 <0.001 
After lunch 195±62 182±54 0.041 
Before dinner 135±47 143±44 0.232 
After dinner 203±62 177±54 <0.001 
mean BG after first day 183±29 162±30 0.014 
Glucose variability, mean±SD    
Individual glucose SD during study 62.5±21 45.0±14 0.001 
Individual glucose CV during study 0.34±0.09 0.27±0.05 0.002 
Hypoglycemic event, N (%)    
Patients <70 mg/dL 9 (33) 3 (11) 0.099 
Insulin therapy, mean±SD U/day    
Total insulin 17.1±6.6 16.1±6.4 0.762 
Total glargine insulin 12.0±5.7 12.6±4.8 0.55 
Total regular insulin 5.4±2.5 3.6±2.8 0.017 
n, number of the measured BGs; N, number of the patients 

Conclusion: BP+DU therapy reduced the frequency of hyperglycemia and hypoglycemia and resulted in a lower GV.

Disclosure

N. Fushimi: None. T. Shibuya: None. Y. Yoshida: None. S. Ito: None. H. Hachiya: None. A. Mori: None.

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