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