Introduction
Materials and Methods
Study Design and Interventions
Study Participants
Randomization and Masking
Study Endpoints
Statistical Analysis
Results
Placebo (n = 90) | Taspoglutide 10 mg (n = 182) | Taspoglutide 20 mg (n = 187) | Sitagliptin 100 mg (n = 177) | |
---|---|---|---|---|
Sex | ||||
Male | 47 (52) | 102 (56) | 98 (52) | 105 (59) |
Female | 43 (48) | 80 (44) | 89 (48) | 72 (41) |
Age, mean (SD), years | 56.1 (10.1) | 55.3 (9.5) | 56.8 (8.8) | 55.5 (9.9) |
Race | ||||
White | 69 (77) | 143 (79) | 153 (82) | 135 (76) |
Asian | 9 (10) | 15 (8) | 14 (7) | 19 (11) |
Black | 5 (6) | 13 (7) | 8 (4) | 10 (6) |
Other | 7 (8) | 11 (6) | 12 (6) | 13 (7) |
Ethnicity | ||||
Non-Hispanic | 80 (89) | 150 (82) | 152 (81) | 148 (84) |
Hispanic | 10 (11) | 32 (18) | 35 (19) | 29 (16) |
Weight, mean (SD), kg | 91.1 (19.0) | 93.6 (20.4) | 91.8 (18.0) | 92.5 (19.7) |
Body mass index, mean (SD), kg/m2
| 32.5 (5.5) | 32.7 (5.2) | 32.3 (5.0) | 32.4 (5.0) |
HbA1c, mean (SD), % | 8.03 (0.83) | 7.95 (0.93) | 7.97 (0.86) | 7.94 (0.85) |
HbA1c baseline category | ||||
<8.0% | 46 (51) | 103 (57) | 106 (57) | 100 (56) |
≥8.0% | 44 (49) | 79 (43) | 81 (43) | 77 (44) |
Fasting plasma glucose, mean (SD), mmol/L | 9.66 (2.60) | 9.74 (2.48) | 9.64 (2.68) | 9.40 (2.50) |
Duration of diabetes, mean (SD), years | 5.5 (3.9) | 6.1 (4.8) | 5.7 (4.7) | 6.0 (5.0) |
Efficacy
Safety and Tolerability
Taspoglutide 10 mg (n = 187) | Taspoglutide 20 mg (n = 192) | Sitagliptin 100 mg (n = 184) | |
---|---|---|---|
Patients with at least one AE | 160 (85.6) | 183 (95.3) | 149 (81.0) |
Total number of AEs, n
| 737 | 931 | 643 |
Patients with at least one serious AE | 18 (9.6) | 18 (9.4) | 19 (10.3) |
Treatment-related serious AEs, %a (n/n serious AEs) | 11 (2/18) | 19 (5/27) | 0 (0/22) |
Death | 1 (0.5) | 0 (0.0) | 0 (0.0) |
AEs leading to withdrawal in >1% | |||
Total patients with ≥1 AE | 53 (28.3) | 69 (35.9) | 13 (7.1) |
Serious AEs | 2 (1.1) | 6 (3.1) | 2 (1.1) |
Gastrointestinal disorders | 34 (18.2) | 39 (20.3) | 3 (1.6) |
Nausea | 14 (7.5) | 21 (10.9) | 0 (0) |
Vomiting | 15 (8.0) | 13 (6.8) | 1 (0.5) |
Diarrhea | 2 (1.1) | 1 (0.5) | 0 (0.0) |
General disorders and administration-site conditions | 5 (2.7) | 7 (3.6) | 1 (0.5) |
Hypersensitivityb
| 4 (2.1) | 8 (4.2) | 1 (0.5) |
AEs reported by >5% of patients | |||
Nausea | 96 (51.3) | 111 (57.8) | 32 (17.4) |
Vomiting | 55 (29.4) | 77 (40.1) | 12 (6.5) |
Diarrhea | 32 (17.1) | 29 (15.1) | 10 (5.4) |
Dyspepsia | 18 (9.6) | 15 (7.8) | 4 (2.2) |
Constipation | 9 (4.8) | 15 (7.8) | 3 (1.6) |
Gastroesophageal reflux disease | 11 (5.9) | 11 (5.7) | 5 (2.7) |
Abdominal pain upper | 4 (2.1) | 6 (3.1) | 10 (5.4) |
Injection-site nodule | 14 (7.5) | 33 (17.2) | 3 (1.6) |
Injection-site pruritus | 13 (7.0) | 33 (17.2) | 4 (2.2) |
Injection-site erythema | 12 (6.4) | 26 (13.5) | 3 (1.6) |
Injection-site pain | 2 (1.1) | 7 (3.6) | 16 (8.7) |
Injection-site mass | 7 (3.7) | 13 (6.8) | 1 (0.5) |
Nasopharyngitis | 14 (7.5) | 15 (7.8) | 28 (15.2) |
Urinary tract infection | 8 (4.3) | 15 (7.8) | 12 (6.5) |
Upper respiratory tract infection | 4 (2.1) | 11 (5.7) | 19 (10.3) |
Influenza | 8 (4.3) | 10 (5.2) | 13 (7.1) |
Hypoglycemia | 21 (11.2) | 15 (7.8) | 18 (9.8) |
Decreased appetite | 20 (10.7) | 23 (12.0) | 5 (2.7) |
Headache | 15 (8.0) | 10 (5.2) | 11 (6.0) |
Dizziness | 11 (5.9) | 14 (7.3) | 9 (4.9) |
Hypertension | 5 (2.7) | 14 (7.3) | 18 (9.8) |
Arthralgia | 7 (3.7) | 6 (3.1) | 11 (6.0) |
Cough | 3 (1.6) | 6 (3.1) | 10 (5.4) |
Hypersensitivityb,c
| 5 (2.7) | 10 (5.2) | 2 (1.1) |
Taspoglutide | Pooled (n = 379) | ||
---|---|---|---|
10 mg (n = 187) | 20 mg (n = 192) | ||
Baseline, n
a
| 172 | 173 | 345 |
Confirmed positive, n (%) | 0 (0) | 2 (1) | 2 (1) |
Week 24, n
| 157 | 166 | 323 |
Confirmed positive, n (%) | 43 (27) | 64 (39) | 107 (33) |
Week 52, n
| 128 | 116 | 244 |
Confirmed positive, n (%) | 48 (38) | 55 (47) | 103 (42) |
Week 64, n
| 74 | 62 | 136 |
Confirmed positive, n (%) | 20 (27) | 20 (32) | 40 (29) |
Week 76, n
| 78 | 66 | 144 |
Confirmed positive, n (%) | 0 (0) | 1 (2) | 1 (1) |
Week 88, n
| 33 | 29 | 62 |
Confirmed positive, n (%) | 15 (45) | 11 (38) | 26 (42) |
Week 104, n
| 3 | 5 | 8 |
Confirmed positive, n (%) | 0 (0) | 2 (40) | 2 (25) |
Postbaseline, n
| 172 | 178 | 350 |
≥1 confirmed positive, n (%) | 71 (41) | 91 (51) | 162 (46)b
|