Table 2.
Clinical studies showing glucose-lowering effects of BASs in patients with type 2 diabetes
| Reference | Study design | Treatment | Duration | n | Background antidiabetic therapy | A1C (%) |
Treatment Difference | Fasting plasma glucose (mmol/l) |
Treatment Difference | LDL cholesterol (% Δ) |
Treatment Difference |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Δ from Baseline | Δ from Baseline | Δ from Baseline | |||||||||
| Cholestyramine | |||||||||||
| Garg and Grundy (4) | R, B, PC, and crossover | Placebo | 6 weeks | 21 | Added to insulin (n = 9) or glyburide (n = 12) | Week 6: −0.4* | −0.5* | Week 6: +0.3† | NR | Week 6: −1.9 | −28‡ |
| Cholestyramine 16 g/day | 19 | Week 6: −0.9* | Week 6: −0.8†‡ | Week 6: −28.9 | |||||||
| Colesevelam HCl | |||||||||||
| Zieve et al. (5) | R, DB, PC, and PG | Placebo | 12 weeks | 34 | Added to SU alone (n = 27), MET alone (n = 9), SU + MET (n = 29) | Week 12: +0.2 | −0.5‡ | Week 12: +0.12 | −0.78 | Week 12: +2.1‖ | −11.7‡ |
| Colesevelam 3.75 g/day | 31 | Week 12: −0.3 | Week 12: −0.28 | Week 12: −9.6 | |||||||
| Goldberg et al. (8) | R, DB, PC, and PG | Placebo | 16 weeks | 147 | Added to insulin alone (n = 116) or in combination with OAD(s) (n = 171) | Week 16: +0.1 | −0.5‡ Total cohort −0.6‡ Insulin alone cohort −0.4‡ Insulin + OAD(s) cohort | Week 16: +1.1 | −0.81 | Week 16: +0.5 | −12.8‡ |
| Colesevelam 3.75 g/day | 140 | Week 16: −0.4 | Week 16: −0.22 | Week 16: −12.3‖ | |||||||
| Fonseca et al. (7) | R, DB, PC, and PG | Placebo | 26 weeks | 231 | Added to SU alone (n = 156) or in combination with other OAD(s) (n = 304) | Week 26: +0.2 | −0.5‡ Total cohort −0.8‡ SU alone cohort −0.4‡ SU + OAD(s) cohort | Week 26: +0.39 | −0.75§ | Week 26: +0.6 | −16.7‡ |
| Colesevelam 3.75 g/day | 230 | Week 26: −0.3 | Week 26: −0.31 | Week 26: −16.1‖ | |||||||
| Bays et al. (6) | R, DB, PC, and PG | Placebo | 26 weeks | 157 | Added to MET alone (n = 159) or in combination with other OAD(s) (n = 157) | Week 26: +0.2 | −0.5‡ Total cohort −0.5‡ MET alone cohort −0.6‡ MET + OAD(s) cohort | Week 26: +0.64 | −0.77§ | Week 26: +4 | −15.9‡ |
| Colesevelam 3.75 g/day | 159 | Week 26: −0.4 | Week 26: −0.26 | Week 26: −12‖ | |||||||
| Colestimide | |||||||||||
| Yamakawa et al. (9) | R, open label, and PG | Pravastatin 10 mg/day | 3 months | 35 | Added to Diet (n = 4), OAD monotherapy (n = 17), OAD combination therapy (n = 34), and insulin (n = 17) | NS | NR | NS | NR | Month 3: −16.2‖ | NR |
| Colestimide 6 g/day | 35 | Month 3: −0.9‖ | Month 3: −0.8‖ | Month 3: −22.9‖ | |||||||
| Suzuki et al. (59) | R, open label, and PG | Acarbose 150 mg/day | 2 weeks | 16 | Diet alone (n = 18), diet + OAD (n = 15) | Week 2: NR# | NR | Week 2: −0.44‖ | NR | NR** | NR |
| Colestimide 3 g/day | 17 | Week 2: NR# | Week 2: −0.48 | NR** |
*Glycosylated hemoglobin; values represent the mean of two determinations on days 28 and 38 during the study periods.
†Mean plasma glucose; for each patient, a mean value was calculated from plasma glucose concentrations measured at 3:00, 7:00, and 11:00 a.m. and at 4:00 and 8:00 p.m. each day for 5 consecutive days.
‡P ≤ 0.007 vs. placebo.
§P < 0.05 vs. placebo.
‖P < 0.05 vs. baseline.
¶No significant change from baseline; values are not reported.
#Because of the short duration of the study, A1C values were not examined, but M value and J index decreased significantly in both groups (P < 0.0001 vs. baseline).
**LDL cholesterol levels not reported, but total cholesterol levels decreased significantly in both groups versus baseline (P ≤ 0.002), with no significant change in HDL cholesterol, suggesting a reduction in LDL cholesterol. DB, double-blind; MET, metformin; NR, not reported; OAD, oral antidiabetic; PC, placebo controlled; PG, parallel group; R, randomized; SU, sulfonylurea.