Summary of clinical trials involving incretin agents
INCRETIN AGENT AND COMBINATION | COMPARATOR | N | DURATION, WK | MEAN CHANGE IN HBA1C, %* |
---|---|---|---|---|
Sitagliptin | ||||
• Monotherapy35,38–43 | Placebo | 2389 | 12–24 | −0.44 to −0.66 |
• Metformin35,40,44 | Placebo | 1437 | 24 | −0.67 to −1.90 |
• Metformin15,35 | Glipizide | 1172 | 52 | −0.67 |
• Glimepiride with or without metformin35,45 | Placebo | 441 | 24 | −0.45 |
• Pioglitazone35,46 | Placebo | 353 | 24 | −0.85 |
• Metformin47 | Exenatide | 61 | 2 | NA |
Vildagliptin | ||||
• Monotherapy35,48–53 | Placebo | 2253 | 12–52 | −0.20 to −0.92 |
• Metformin54,55 | Placebo | 651 | 12–24 | −0.60 to −0.90 |
• Insulin56 | Placebo | 296 | 24 | −0.50 |
• Metformin16 | Pioglitazone | 576 | 24 | −0.88 |
• Pioglitazone57 | Placebo | 463 | 24 | −1.00 |
• Various59 | Vildagliptin vs pioglitazone vs vildagliptin and pioglitazone | 607 | 24 | −1.1 |
Exenatide | ||||
• Sulfonylurea24 | Placebo | 377 | 30 | −0.86 |
• Metformin25 | Placebo | 336 | 30 | −0.8 |
• Metformin and sulfonylurea26 | Placebo | 733 | 30 | −0.75† |
• TZD with or without metformin27 | Placebo | 233 | 16 | −0.89 |
• Metformin and sulfonylurea20,21 | Insulin glargine | 689 | 26–32 | −1.36 to −1.16 |
• Metformin and sulfonylurea22 | Biphasic insulin | 501 | 52 | −1.04 |
• Monotherapy31 | Placebo | 232 | 24 | −0.9 |
• Metformin, sulfonylurea, or both28 | None | 314 | 82 | −1.1 |
• Metformin, sulfonylurea, or both59 | Placebo | 217 | 156 | −1.0 |
Liraglutide | ||||
• Monotherapy (LEAD-3)18 | Glimepiride | 746 | 52 | −0.84 to −1.14 |
• Metformin (LEAD-2)33 | Placebo or glimepiride | 1091 | 26 | −1.0 |
• Glimepiride (LEAD-1)32 | Placebo or rosiglitazone | 1041 | 26 | −1.1 |
• Metformin and rosiglitazone (LEAD-4)34 | Placebo | 533 | 26 | −1.5 |
• Metformin and sulfonylurea (LEAD-5)23 | Insulin glargine | 581 | 26 | −1.33 |
• Previous oral antihyperglycemics (LEAD-6)60 | Exenatide plus previous oral antihyperglycemics | 464 | 26 | −1.12 |
HbA1c—glycated hemoglobin A1c, LEAD—Liraglutide Effect and Action in Diabetes, NA—not applicable, TZD—thiazolidinedione.
↵* Reported mean change from baseline in patients treated with incretin agents. Where several values are provided (eg, different doses of the study drug), either in a single report or in multiple reports, the range of reported mean values is shown.
↵† Precise value not reported; reduction in HbA1c levels was shown in a figure.