Table 1.
Summary of Clinical Data Evaluating the Effects of Oral Antidiabetes Agents on HbAlc Weight, and Lipid Parameters in Patients with Type 2 Diabetes
| Agent | Study | Patient Population Randomized to Treatment Arm (n) |
Dosage | HbAlc, Percent Change From Baseline in Absolute Units |
Weight, kg Change From Baseline |
Lipids, Change From Baseline |
|---|---|---|---|---|---|---|
| Glimepiride | Yamanouchi 200560 |
37 (treatment-naïve to OAD) |
Glimepiride 1–2 mg/day for 12 mo |
−2.1a | −0.2 (BMI) | (mmol/L) TC, −0.19; HDL-C.−0.01; TG, 10.05 |
| Nauck 200952 |
244 | Glimepiride (in combination with metformin) 4 mg/day for 26 wk |
−1.0 | +1.0 | NR | |
| Garber 200948 (LEAD-3) |
248 (receiving OAD plus diet/exercise) |
Glimepiride 8 mg/day for 52 wk |
−0.51 | +1.02 | NR | |
| Metformin | Yamanouchi 200560 |
39 (treatment-naïve to OAD) |
Metformin 750 mg/day for 12 mo |
−2.1a | −0.7 (BMI) | (mmol/L) TC. −0.18; HDL-C. −0.01; TG, −0.09 |
| Yilmaz 200761 |
17 (receiving insulin) | Metformin 1700 mg/day for 6 mo |
−2.0a | +1.4 | (mg/dL) TC, −2.3; LDL-C, +2.2; HDLC, −0.1; TG, −16.5a |
|
| Kawai 200849 |
35 (Japanese patients who received metformin 500–750 mg/day for 12wk) |
Metformin 500–750 mg/day for 6 mo |
−0.1 | +0.1 | (mg/dL) TC, +0.9; HDL-C, +0.2; TG, −6.0 |
|
| Kusaka 200350 |
17 (Japanese patients treated with diet/exercise alone or with glimepiride 2 mg/day) |
Metformin 750 mg/day for 4 mo |
−1.0a | No change (BMI) | (mmol/L) LDL-C, −0.3; HDL-C. no change: TG, +0.2 |
|
| Acarbose | Yilmaz 200761 |
15 (receiving insulin) | Acarbose 300 mg/day for 6 mo |
−0.6a | +2.7 | (mg/dL) TC, −2.3; LDL-C, +6.9; HDL-C+1.7; TG, −27.4a |
| Pan 200853 | 220 (treatment-naïve) | Acarbose ≤ 300 mg/day for 24 wk |
−1.3 | −1.7 | NR | |
| Pioglitazone | Yamanouchi 200560 |
38 (treatment-naïve to OAD) |
Pioglitazone 30–45 mg/day for 12 mo |
−2.3a | +0.9 (BMI) | (mmol/L) TC, −0.23; HDL-C, +0.11; TG, −0.39 |
| Kawai 200849 |
28 (Japanese patients who received metformin 500–750 mg/day for 12 wk) |
Pioglitazone 15 mg/day for 6 mo |
-1.2a | +2.2a | (mg/dL) TC, + 1.5; HDL-C, +5.6a; TG.-13.5 |
|
| Kusaka 200850 |
16 (Japanese patients treated with diet/exercise alone or with glimepiride 2 mg/day) |
Pioglitazone 15 mg/day (women) or 30 mg/day (men) for 4 mo |
−1.1a | +0.9a (BMI) | (mmol/L) LDL-C, no change; HDL-C, +0.2; TG, +0.2 |
|
| Miyazaki 200851 |
21 (treatment-naïve or receiving sulfonylurea) |
Pioglitazone 45 mg/day for 3 mo |
−1.3a | +2.7a | (mg/dL) LDL-C, +1.0a; HDL-C, +2.0; TG, −47.0a |
|
| Rosiglitazone | Rosen stock 200657 |
112 (insulin-naïve; receiving sulfonylurea plus metformin) |
Rosiglitazone 4 mg/day for 24 wk |
−1.51 | +3.0 | (mg/dL) TC,+19.0; LDL-C, +14.0; HDL-C, +4.4%; TG, +11.0 |
| Yilmaz 200761 |
15 (receiving insulin) | Rosiglitazone 8 mg/day for 6 mo |
−2.5a | +4.6 | (mg/dL) TC, −12.5; LDL-C, −11.9; HDL-C. +3.3; TG, −29.7a |
|
| Miyazaki 200851 |
37 (treatment-naïve or receiving sulfonylurea) |
Rosiglitazone 8 mg/day for 3 mo |
−1.4a | +2.9a | (mg/dL) LDL-C. +15.0a; HDL-C, +4.0; TG, −8.0a |
|
| Scott 200859 |
87 (receiving metformin) | Rosiglitazone 8 mg/day for 18 wk |
−0.79 | +1.5 | (mg/dL, at wk 24) TC, +26.2; LDL-C, +20.4; HDL-C, +3.5; TG.-1.8 |
|
| Repaglinide | Rosenstock 200456 |
76 (treated with diet/ exercise for previous 3 mo) |
Repaglinide 0.5–4.0 mg/meal for 16 wk 120 mg/meal for 16 wk |
−1.57a | +1.8 | NR |
| Nateglinide | Rosenstock 200456 |
74 (treated with diet/ exercise for previous 3 mo) |
Nateglinide 60–120 mg/meal for 16 wk |
−1.04 | +0.7 | NR |
| Sitagliptin | Aschner 200646 |
467 (not receiving an OAD) |
Sitagliptin 100–200 mg/day for 24 wk |
−0.61 to −0.76a | −0.1 to −0.2 | NR |
| Raz 200654 | 392 (uncontrolled by diet/exercise) |
Sitagliptin 100–200 mg/day for 18 wk |
−0.36 to −0.48a | −0.2 to −0.6 | NR | |
| Rosenstock 200658 |
175 (added to pioglitazone) |
Sitagliptin 100 mg/day plus pioglitazone for 24 wk |
−0.85a | +1.8 | (mg/dL) TC, +1.7; LDL-C, +1.2; HDL-C,+0.1; TG, −1.1 |
|
| DeFronzo 200847 |
61 (receiving metformin) | Sitagliptin 100 mg/day for 2 wk (then crossover to exenatide) |
−19 (FPG, mg/dL) | −0.3 | NR | |
| Raz 200855 | 96 (receiving metformin for > 6 wk) |
Sitagliptin 100 mg/day for 30 wk |
−1.0a | −0.5 | No significant between-group differences in TC, LDL-C, HDL-C |
|
| Scott 200859 |
94 (receiving metformin) | Sitagliptin 100 mg/day for 18 wk |
−0.73 | −0.4 | (mg/dL, at wk 24) TC +8.1; LDL-C, +9.2; HDL-C, +1.8: TG, −14.5 |
a
P < 0.05.
Abbreviations: BMI, body mass index; FPG. fasting plasma glucose: HDL-C. high-density lipoprotein cholesterol; LEAD. Liraglutide Effects and Actions in Diabetes; LDL-C, low-density lipoprotein cholesterol: NR, not reported; OAD. oral antidiabetes (agent); TC. total cholesterol; TG, triglyceride.