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Insulin degludec compared with insulin glargine in insulin-naïve patients with type 2 diabetes: A 26-week, randomized, controlled, Pan-Asian, treat-to-target trial.

Onishi Y, Iwamoto Y, Yoo SJ, Clauson P, Tamer SC, Park S - J Diabetes Investig (2013)

Bottom Line: Insulin degludec (IDeg) is an ultra-long-acting basal insulin with a consistent action profile of >42 h.After 26 weeks, HbA1c had decreased by 1.24 and 1.35% in the IDeg and IGlar groups, respectively (treatment difference [IDeg - IGlar] 0.11%, 95% confidence interval [CI] -0.03 to 0.24), confirming non-inferiority.Initiating insulin therapy with IDeg in Asian patients with type 2 diabetes, inadequately controlled with OADs, provides similar improvements in long-term glycemic control to IGlar, but at a significantly lower rate of overall confirmed hypoglycemia once stable glycemic control and insulin dosing are achieved.

View Article: PubMed Central - PubMed

Affiliation: The Institute for Adult Diseases Asahi Life Foundation Tokyo Japan.

ABSTRACT

Introduction: Insulin degludec (IDeg) is an ultra-long-acting basal insulin with a consistent action profile of >42 h. This trial compared the efficacy and safety of IDeg with insulin glargine (IGlar) in insulin-naïve Asian patients with type 2 diabetes.

Materials and methods: In this multinational, 26-week, open-label, treat-to-target trial, 435 participants (202 females, 233 males; mean age 58.6 years; mean body mass index 25 kg/m(2); mean glycated hemoglobin [HbA1c] 8.5%) were randomized (2:1) to IDeg or IGlar, each administered once daily with ≥1 oral antidiabetic drug(s) (OAD).

Results: After 26 weeks, HbA1c had decreased by 1.24 and 1.35% in the IDeg and IGlar groups, respectively (treatment difference [IDeg - IGlar] 0.11%, 95% confidence interval [CI] -0.03 to 0.24), confirming non-inferiority. Rates of overall confirmed hypoglycemia were similar for IDeg and IGlar during the full trial period (3.0 vs 3.7 episodes/patient-year of exposure [PYE]; rate ratio [RR] 0.82, 95% CI 0.60 to 1.11, P = 0.20), but significantly lower (by 37%) for IDeg during the maintenance period (from week 16 onward; RR 0.63, 95% CI 0.42 to 0.94, P = 0.02). No significant difference in the rate of nocturnal confirmed hypoglycemia was found between IDeg and IGlar in the full trial period (0.8 vs 1.2 episodes/PYE; RR 0.62, 95% CI 0.38 to 1.04, P = 0.07) or maintenance period (RR 0.52, 95% CI 0.27 to 1.00, P = 0.05). Adverse event rates were similar between treatments.

Conclusions: Initiating insulin therapy with IDeg in Asian patients with type 2 diabetes, inadequately controlled with OADs, provides similar improvements in long-term glycemic control to IGlar, but at a significantly lower rate of overall confirmed hypoglycemia once stable glycemic control and insulin dosing are achieved. This trial was registered with www.clinicaltrials.gov (no. NCT01059799).

No MeSH data available.


Related in: MedlinePlus

Mean (a) glycated hemoglobin (HbA1c) and (b) fasting plasma glucose (FPG) over time. Data are observed mean values for all randomized participants (last observation carried forward is used for each post‐baseline time‐point). Error bars show standard error of the mean. IDeg, insulin degludec; IGlar insulin glargine.
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jdi12102-fig-0002: Mean (a) glycated hemoglobin (HbA1c) and (b) fasting plasma glucose (FPG) over time. Data are observed mean values for all randomized participants (last observation carried forward is used for each post‐baseline time‐point). Error bars show standard error of the mean. IDeg, insulin degludec; IGlar insulin glargine.

Mentions: After 26 weeks of treatment, the observed mean HbA1c concentration was similar for IDeg (7.2%) and IGlar (7.1%), as were mean decreases from baseline (−1.24 and −1.35%, respectively; Figure 2a). The estimated mean treatment difference (ETD) between IDeg and IGlar was 0.11% [95% CI −0.03 to 0.24], showing that IDeg was non‐inferior to IGlar in lowering HbA1c. The results of the primary analysis were supported by a per‐protocol analysis and additional sensitivity analyses (Table S2).


Insulin degludec compared with insulin glargine in insulin-naïve patients with type 2 diabetes: A 26-week, randomized, controlled, Pan-Asian, treat-to-target trial.

Onishi Y, Iwamoto Y, Yoo SJ, Clauson P, Tamer SC, Park S - J Diabetes Investig (2013)

Mean (a) glycated hemoglobin (HbA1c) and (b) fasting plasma glucose (FPG) over time. Data are observed mean values for all randomized participants (last observation carried forward is used for each post‐baseline time‐point). Error bars show standard error of the mean. IDeg, insulin degludec; IGlar insulin glargine.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4020256&req=5

jdi12102-fig-0002: Mean (a) glycated hemoglobin (HbA1c) and (b) fasting plasma glucose (FPG) over time. Data are observed mean values for all randomized participants (last observation carried forward is used for each post‐baseline time‐point). Error bars show standard error of the mean. IDeg, insulin degludec; IGlar insulin glargine.
Mentions: After 26 weeks of treatment, the observed mean HbA1c concentration was similar for IDeg (7.2%) and IGlar (7.1%), as were mean decreases from baseline (−1.24 and −1.35%, respectively; Figure 2a). The estimated mean treatment difference (ETD) between IDeg and IGlar was 0.11% [95% CI −0.03 to 0.24], showing that IDeg was non‐inferior to IGlar in lowering HbA1c. The results of the primary analysis were supported by a per‐protocol analysis and additional sensitivity analyses (Table S2).

Bottom Line: Insulin degludec (IDeg) is an ultra-long-acting basal insulin with a consistent action profile of >42 h.After 26 weeks, HbA1c had decreased by 1.24 and 1.35% in the IDeg and IGlar groups, respectively (treatment difference [IDeg - IGlar] 0.11%, 95% confidence interval [CI] -0.03 to 0.24), confirming non-inferiority.Initiating insulin therapy with IDeg in Asian patients with type 2 diabetes, inadequately controlled with OADs, provides similar improvements in long-term glycemic control to IGlar, but at a significantly lower rate of overall confirmed hypoglycemia once stable glycemic control and insulin dosing are achieved.

View Article: PubMed Central - PubMed

Affiliation: The Institute for Adult Diseases Asahi Life Foundation Tokyo Japan.

ABSTRACT

Introduction: Insulin degludec (IDeg) is an ultra-long-acting basal insulin with a consistent action profile of >42 h. This trial compared the efficacy and safety of IDeg with insulin glargine (IGlar) in insulin-naïve Asian patients with type 2 diabetes.

Materials and methods: In this multinational, 26-week, open-label, treat-to-target trial, 435 participants (202 females, 233 males; mean age 58.6 years; mean body mass index 25 kg/m(2); mean glycated hemoglobin [HbA1c] 8.5%) were randomized (2:1) to IDeg or IGlar, each administered once daily with ≥1 oral antidiabetic drug(s) (OAD).

Results: After 26 weeks, HbA1c had decreased by 1.24 and 1.35% in the IDeg and IGlar groups, respectively (treatment difference [IDeg - IGlar] 0.11%, 95% confidence interval [CI] -0.03 to 0.24), confirming non-inferiority. Rates of overall confirmed hypoglycemia were similar for IDeg and IGlar during the full trial period (3.0 vs 3.7 episodes/patient-year of exposure [PYE]; rate ratio [RR] 0.82, 95% CI 0.60 to 1.11, P = 0.20), but significantly lower (by 37%) for IDeg during the maintenance period (from week 16 onward; RR 0.63, 95% CI 0.42 to 0.94, P = 0.02). No significant difference in the rate of nocturnal confirmed hypoglycemia was found between IDeg and IGlar in the full trial period (0.8 vs 1.2 episodes/PYE; RR 0.62, 95% CI 0.38 to 1.04, P = 0.07) or maintenance period (RR 0.52, 95% CI 0.27 to 1.00, P = 0.05). Adverse event rates were similar between treatments.

Conclusions: Initiating insulin therapy with IDeg in Asian patients with type 2 diabetes, inadequately controlled with OADs, provides similar improvements in long-term glycemic control to IGlar, but at a significantly lower rate of overall confirmed hypoglycemia once stable glycemic control and insulin dosing are achieved. This trial was registered with www.clinicaltrials.gov (no. NCT01059799).

No MeSH data available.


Related in: MedlinePlus