Table 1.
Baseline characteristics of patients in the study groups
| Placebo | 0.6 mg | 1.2 mg | 1.8 mg | P | |
|---|---|---|---|---|---|
| n | 17 | 14 | 16 | 16 | |
| Age (years) | 50 ± 3 | 45 ± 4 | 42 ± 3 | 42 ± 3 | 0.27 |
| Age of T1D diagnosis (years) | 19 ± 3 | 19 ± 3 | 21 ± 3 | 21 ± 3 | 0.92 |
| Duration of T1D (years) | 30 ± 3 | 25 ± 2 | 21 ± 3 | 20 ± 3 | 0.04 |
| Sex (male/female) | 7/10 | 9/9 | 8/5 | 4/11 | 0.29§ |
| HbA1c, % (mmol/mol) | 7.69 ± 0.17 (61 ± 2) | 7.46 ± 0.19 (58 ± 2) | 7.84 ± 0.17 (62 ± 2) | 7.41 ± 0.15 (57 ± 1.6) | 0.24 |
| Average glucose (CGMS), mmol/L (mg/dL) | 9.37 ± 0.44 (169 ± 8) | 8.99 ± 0.38 (162 ± 7) | 9.32 ± 0.33 (168 ± 6) | 9.43 ± 0.27 (170 ± 5) | 0.93 |
| Fasting glucose (CGMS), mmol/L (mg/dL) | 9.54 ± 0.66 (172 ± 12) | 8.71 ± 0.66 (157 ± 12) | 8.43 ± 0.55 (152 ± 10) | 9.21 ± 0.44 (166 ± 8) | 0.61 |
| SD (CGMS), mmol/L (mg/dL) | 4.2 ± 0.22 (76 ± 4) | 4.05 ± 0.22 (73 ± 4) | 4.16 ± 0.16 (75 ± 3) | 3.9 ± 0.16 (70 ± 3) | 0.77 |
| Body weight (kg) | 80 ± 6 | 80 ± 4 | 96.0 ± 4 | 83 ± 4 | 0.08 |
| BMI (kg/m2) | 28 ± 2 | 26 ± 3 | 33 ± 2 | 28 ± 4 | 0.20 |
| Total insulin dose (units) | 46.1 ± 9.5 | 52.8 ± 3.7 | 71.2 ± 5.5¶$ | 48.1 ± 4.3 | 0.01 |
| Basal insulin dose (units) | 26.0 ± 5.1 | 30.70 ± 2.9 | 42.6 ± 4.5¶$ | 27.0 ± 2.3 | 0.01 |
| Bolus insulin dose (units) | 24.2 ± 5.1 | 21.9 ± 2.2 | 28.0 ± 3.2 | 20.9 ± 2.8 | 0.46 |
| Daily carbohydrate intake (g) | 160 ± 15 | 161 ± 29 | 171 ± 17 | 153 ± 18 | 0.95 |
| Daily carbohydrate helpings (meals/day) | 4.1 ± 0.3 | 3.7 ± 0.4 | 3.5 ± 0.3 | 3.3 ± 0.3¶ | 0.18 |
| SBP (mmHg) | 122 ± 4 | 125 ± 4 | 121 ± 3 | 120 ± 2 | 0.78 |
| Diastolic blood pressure (mmHg) | 75 ± 3 | 75 ± 3 | 75 ± 2 | 77 ± 2 | 0.92 |
| Pulse rate | 76 ± 2 | 75 ± 2 | 75 ± 2 | 75 ± 2 | 0.16 |
| % time spent at BG concentrations (CGMS) | |||||
| <3.05 mmol/L (55 mg/dL) | 4 ± 1 | 3 ± 1 | 3 ± 1 | 2 ± 1 | 0.60 |
| 3.05–3.88 mmol/L (55–70 mg/dL) | 5 ± 1 | 5 ± 1 | 4 ± 1 | 4 ± 1 | 0.32 |
| 3.8–8.8 mmol/L (70–160 mg/dL) | 43 ± 3 | 49 ± 3 | 45 ± 2 | 44 ± 3 | 0.74 |
| 8.8–13.3 mmol/L (160–240 mg/dL) | 29 ± 2 | 27 ± 2 | 30 ± 2 | 33 ± 2 | 0.39 |
| 13.3–22.25 mmol/L (240–400 mg/dL) | 18 ± 3 | 15 ± 2 | 18 ± 2 | 18 ± 3 | 0.94 |
| Episodes of hypoglycemia/total number of SMBG readings (incidence %) | |||||
| <3.05 mmol/L (55 mg/dL) | 1/36 (2) | 1/37 (2) | 1/36 (2) | 1/37 (2) | 0.84 |
| 3.05–3.88 mmol/L (55–70 mg/dL) | 2/36 (5) | 4/37 (10) | 3/36 (8) | 1/37 (2) | 0.31 |
| Glucagon levels (ng/L) | 97 ± 14 | 106 ± 12 | 112 ± 18 | 95 ± 13 | 0.38 |
| Total GLP-1 (pmol/L) | 23 ± 9 | 21 ± 3 | 28 ± 5 | 20 ± 3 | 0.24 |
| Total GIP (pg/mL) | 78 ± 14 | 73 ± 18 | 91 ± 20 | 73 ± 12 | 0.41 |
| FFAs (mmol/L) | 0.51 ± 0.08 | 0.58 ± 0.11 | 0.49 ± 0.12 | 0.55 ± 0.07 | 0.52 |
| CRP (g/L) | 3.05 ± 0.57 | 3.17 ± 1.0 | 3.01 ± 0.92 | 3.53 ± 0.67 | 0.73 |
Data are means ± SEM unless otherwise indicated.
¶Significant compared with placebo (P < 0.05).
§χ2 test.
$Significant compared with 1.8-mg group (P < 0.05).