Addition of insulin lispro protamine suspension or insulin glargine to oral type 2 diabetes regimens: a randomized trial

Strojek, Krzysztof; Shi, Chunhong; Carey, Michelle A.; Jacober, Scott J.

doi:10.1111/j.1463-1326.2010.01257.x

Cited by 24 publications

(32 citation statements)

References 10 publications

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“…In addition, this inhibitory action can induce mild osmotic diuresis and increase urinary excretion of glucose with modest caloric elimination leading to weight loss (2,3). Dapagliflozin, an SGLT2 inhibitor (4), has been shown to improve glycemic control in patients with type 2 diabetes as monotherapy (5) and in combination with metformin (6), sulfonylurea (7), or insulin (8), but not yet with a thiazolidinedione.…”

mentioning

confidence: 99%

Effects of Dapagliflozin, an SGLT2 Inhibitor, on HbA1c, Body Weight, and Hypoglycemia Risk in Patients With Type 2 Diabetes Inadequately Controlled on Pioglitazone Monotherapy

Rosenstock

Vico²,

et al. 2012

Diabetes Care

369

335

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OBJECTIVETo examine the safety and efficacy of dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, added on to pioglitazone in type 2 diabetes inadequately controlled on pioglitazone.RESEARCH DESIGN AND METHODSTreatment-naive patients or those receiving metformin, sulfonylurea, or thiazolidinedione entered a 10-week pioglitazone dose-optimization period with only pioglitazone. They were then randomized, along with patients previously receiving pioglitazone ≥30 mg, to 48 weeks of double-blind dapagliflozin 5 (n = 141) or 10 mg (n = 140) or placebo (n = 139) every day plus open-label pioglitazone. The primary objective compared HbA1c change from baseline with dapagliflozin plus pioglitazone versus placebo plus pioglitazone at week 24. Primary analysis was based on ANCOVA model using last observation carried forward; all remaining analyses used repeated-measures analysis.RESULTSAt week 24, the mean reduction from baseline in HbA1c was −0.42% for placebo versus −0.82 and −0.97% for dapagliflozin 5 and 10 mg groups, respectively (P = 0.0007 and P < 0.0001 versus placebo). Patients receiving pioglitazone alone had greater weight gain (3 kg) than those receiving dapagliflozin plus pioglitazone (0.7–1.4 kg) at week 48. Through 48 weeks: hypoglycemia was rare; more events suggestive of genital infection were reported with dapagliflozin (8.6–9.2%) than placebo (2.9%); events suggestive of urinary tract infection showed no clear drug effect (5.0–8.5% for dapagliflozin and 7.9% for placebo); dapagliflozin plus pioglitazone groups had less edema (2.1–4.3%) compared with placebo plus pioglitazone (6.5%); and congestive heart failure and fractures were rare.CONCLUSIONSIn patients with type 2 diabetes inadequately controlled on pioglitazone, the addition of dapagliflozin further reduced HbA1c levels and mitigated the pioglitazone-related weight gain without increasing hypoglycemia risk.

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mentioning

confidence: 99%

Effects of Dapagliflozin, an SGLT2 Inhibitor, on HbA1c, Body Weight, and Hypoglycemia Risk in Patients With Type 2 Diabetes Inadequately Controlled on Pioglitazone Monotherapy

Rosenstock

Vico²,

et al. 2012

Diabetes Care

369

335

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“…Of the five potentially relevant trials, one was excluded because it compared ILPS with glargine in a basal-bolus insulin regimen. In conclusion, four studies comparing treatment with ILPS with treatment with insulin glargine or detemir in persons with type 2 diabetes were examined as full text (17–20) (Supplementary Fig. 1).…”

Section: Resultsmentioning

confidence: 99%

“…We did not investigate publication bias using graphical or statistical methods owing to the small number of trials; accordingly, the power of these methods is limited and results from such analyses should be treated with considerable caution (16). We planned to perform three sensitivity analyses in order to explore the influence of the following factor on effect size: by repeating the analysis including patients who took a once-daily insulin dose, as in two studies (17,18), an additional daily insulin ILPS injection could be added by the study personnel, excluding the study of Arakaki et al (19) reported in abstract form and including the three studies comparing ILPS with glargine (17,19,20). P values <0.05 were considered significant, and all reported P values are two sided.…”

Section: Methodsmentioning

confidence: 99%

Basal Supplementation of Insulin Lispro Protamine Suspension Versus Insulin Glargine and Detemir for Type 2 Diabetes

et al. 2012

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OBJECTIVEWe compared the effect of insulin lispro protamine suspension (ILPS) with that of insulin glargine and insulin detemir, all given as basal supplementation, in the treatment of patients with type 2 diabetes.RESEARCH DESIGN AND METHODSWe conducted an electronic search until February 2012, including online registries of ongoing trials and abstract books. All randomized controlled trials comparing ILPS with insulin glargine or detemir with a duration of ≥12 weeks were included.RESULTSWe found four trials lasting 24–36 weeks involving 1,336 persons: three studies compared ILPS with glargine, and one trial compared ILPS with detemir. There was no significant difference in change in HbA1c level between ILPS and comparators, in the proportion of patients achieving the HbA1c goals of ≤6.5 or <7%, in weight change, or in daily insulin doses. There was no difference in overall hypoglycemia, but nocturnal hypoglycemia occurred significantly more with ILPS than with comparator insulins (mean difference 0.099 events/patient/30 days [95% CI 0.03–0.17]). In a prespecified sensitivity analysis comparing data obtained in patients who remained on their once-daily insulin regimen, not significantly different event rates for nocturnal hypoglycemia were observed between ILPS and comparator insulins (0.063 [−0.007 to 0.13]), and ILPS was associated with lower insulin dose (0.07 units/kg/day [0.05–0.09]).CONCLUSIONSThere is no difference between ILPS and insulin glargine or detemir for targeting hyperglycemia, but nocturnal hypoglycemia occurred more frequently with ILPS than with comparator insulins. Nocturnal hypoglycemia was not significantly different in people who injected insulin once daily.

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“…The 24-week open-label trial by Strojek and colleagues [Strojek et al 2010] compared ILPS once or twice daily versus glargine once daily. Glycemic control and overall incidence of hypoglycemia were similar.…”

Section: Comparison Of Ilps With Other Long-acting Analogsmentioning

confidence: 99%

Efficacy and safety of insulin lispro protamine suspension as basal supplementation in patients with type 2 diabetes

Giugliano

Esposito

2012

Therapeutic Advances in Endocrinology

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Abstract:The three currently marketed long-acting insulin analogs, glargine, detemir and insulin lispro protamine suspension (ILPS), represent the most significant advances in basal insulin supplementation since the 1940s and 1950s and the introduction of the intermediateacting NPH (neutral protamine Hagedorn) insulin. As injection of NPH insulin lacks chronic maintenance of a steady-state low-level basal insulin during fasting periods, which can also expose patients to unpredictable nocturnal hypoglycemia, long-acting insulin analogs have been developed to overcome this important limitation of NPH insulin. ILPS is a protaminebased, intermediate-acting insulin formulation of the short-acting analog insulin lispro: its pharmacokinetic and pharmacodynamic characteristics are quite similar to the other basal insulin analogs glargine and detemir. In recent head-to-head randomized controlled trials of insulin-naïve patients with type 2 diabetes, ILPS achieved similar glycemic control compared with glargine or detemir. ILPS administered once daily is an effective and safe way to maintain a steady-state low-level basal insulin during night time, not dissimilar from that currently obtained with a one-day glargine or detemir administration.

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Addition of insulin lispro protamine suspension or insulin glargine to oral type 2 diabetes regimens: a randomized trial

Abstract: At endpoint, ILPS was non-inferior to glargine in HbA1c change from baseline, but associated with increased risk of hypoglycaemia.

Cited by 24 publications

References 10 publications

Effects of Dapagliflozin, an SGLT2 Inhibitor, on HbA1c, Body Weight, and Hypoglycemia Risk in Patients With Type 2 Diabetes Inadequately Controlled on Pioglitazone Monotherapy

Effects of Dapagliflozin, an SGLT2 Inhibitor, on HbA1c, Body Weight, and Hypoglycemia Risk in Patients With Type 2 Diabetes Inadequately Controlled on Pioglitazone Monotherapy

Basal Supplementation of Insulin Lispro Protamine Suspension Versus Insulin Glargine and Detemir for Type 2 Diabetes

Efficacy and safety of insulin lispro protamine suspension as basal supplementation in patients with type 2 diabetes

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