| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 5871246 | Primary Care Diabetes | 2015 | 7 Pages |
â¢BIAsp 30 therapy after sitagliptin failure is effective and well tolerated.â¢Different outcomes using 3 distinct intensification regimens with BIAsp 30.â¢Twice-daily BIAsp 30 + sitagliptin had superior glycaemic control.â¢Once-daily BIAsp 30 + sitaglitpin had a low rate of hypoglycaemia and no weight gain.
AimsInvestigate efficacy and tolerability of intensifying diabetes treatment with once- or twice-daily biphasic insulin aspart 30 (BIAsp 30) added to sitagliptin, and twice-daily BIAsp 30 without sitagliptin in patients with type 2 diabetes (T2D) inadequately controlled on sitagliptin.MethodsOpen-label, three-arm, 24-week trial; 582 insulin-naïve patients were randomized to twice-daily BIAsp 30Â +Â sitagliptin (BIAsp BIDÂ +Â Sit), once-daily BIAsp 30Â +Â sitagliptin (BIAsp QDÂ +Â Sit) or twice-daily BIAsp 30 without sitagliptin (BIAsp BID), all with metformin.ResultsAfter 24 weeks, HbA1c reduction (%) was superior with BIAsp BIDÂ +Â Sit vs. BIAsp QDÂ +Â Sit (BIAsp BIDÂ +Â Sit minus BIAsp QDÂ +Â Sit difference: â0.36 [95% CI -0.54; -0.17], PÂ <Â 0.001) and BIAsp BID (BIAsp BID minus BIAsp BIDÂ +Â Sit difference: 0.24 [0.06; 0.43], PÂ =Â 0.01). Observed final HbA1c values were 6.9%, 7.2% and 7.1% (baseline 8.4%), and 59.8%, 46.5% and 49.7% of patients achieved HbA1c <7.0%, respectively. Confirmed hypoglycaemia was lower with BIAsp QDÂ +Â Sit vs. BIAsp BID (PÂ =Â 0.015); rate: 1.17 (BIAsp QDÂ +Â Sit), 1.50 (BIAsp BIDÂ +Â Sit) and 2.24 (BIAsp BID) episodes/patient-year. Difference in bodyweight change favoured BIAsp QDÂ +Â Sit vs. both BID groups (PÂ <Â 0.001).ConclusionsAdding BIAsp 30 to patients with T2D poorly controlled with sitagliptin and metformin is efficacious and well tolerated; however, while BIAsp BIDÂ +Â Sit showed superior glycaemic control, BIAsp QDÂ +Â Sit had a lower rate of hypoglycaemia and showed no weight gain.
