Effects of insulin glulisine as mono- or add-on therapy in patients with type 2 diabetes mellitus

Ryuzo Kawamori, Y. Iwamoto, T. Kadowaki, M. Iwasaki, S. W. Kim, J. T. Woo, Sei-Hyun Baik, K. H. Yoon

Research output: Contribution to journalArticle

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Abstract

Aim: To evaluate the safety and efficacy of insulin glulisine (glulisine) with and without oral antidiabetic drugs (OAD; sulphonylurea or sulphonylurea + biguanide) relative to that of OAD alone in Japanese and Korean patients with inadequately controlled type 2 diabetes mellitus (T2DM). Methods: In an open, randomized, parallel-group, comparative, controlled trial, 387 patients were randomized and treated with glulisine + OAD (n = 130), glulisine monotherapy (n = 127) or OAD only (n = 130) for 16 weeks. Glulisine was self-injected subcutaneously three times daily (0-15 minutes before meals) at a starting dose of ≥0.2 U/kg/day. Patients titrated the glulisine dose to achieve a 2-h postprandial plasma glucose (2h-PPG) level of 7.1-9.5 mmol/l (128-172 mg/dl) by administering at least one additional unit at each appropriate meal time if the 2h-PPG level was > 9.5 and < 11.1 mmol/l (> 172 and < 200 mg/dl) and by administering at least two additional units if the 2h-PPG level was ≥ 11.1 mmol/l (≥ 200 mg/dl). Therapy with OAD was continued at the stable baseline regimen. The primary efficacy endpoint was change in haemoglobin A1c (HbA1c) from baseline to endpoint in the intention-to-treat population. Results: At baseline, therapy with OAD was a sulphonylurea only and a sulphonylurea + a biguanide in approximately 24 and 76% of patients respectively. Both glulisine groups had larger reductions in adjusted mean HbA1c than the OAD-only group (glulisine + OAD, -2.07%; glulisine monotherapy, -1.25%; OAD only, -0.61%). Superiority of glulisine + OAD and glulisine monotherapy vs. OAD only was shown by differences in adjusted mean HbA1c change from baseline values of -1.46% (p < 0.0001) and -0.64% (p < 0.0001) respectively. Both glulisine groups had better 2h-PPG control than the OAD-only group. Mean daily glulisine doses increased from baseline to endpoint (glulisine + OAD, 13.3-22.5 U; glulisine monotherapy, 14.2-38.0 U). The rate of all symptomatic hypoglycaemia events per patient-year in the entire treatment phase was 11.9 in the glulisine + OAD group, 8.8 in the glulisine monotherapy group and 1.7 in the OAD-only group. There was only one event of severe hypoglycaemia, which occurred in the glulisine + OAD group. Efficacy and safety were similar in Japanese and Korean subpopulations. Conclusions: Both glulisine + OAD and glulisine monotherapy were well tolerated and effective for Japanese and Korean patients with T2DM mellitus inadequately controlled by OAD therapy alone.

Original languageEnglish
Pages (from-to)900-909
Number of pages10
JournalDiabetes, Obesity and Metabolism
Volume11
Issue number9
DOIs
Publication statusPublished - 2009 Sep 2

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Type 2 Diabetes Mellitus
Biguanides
Glucose
Hemoglobins
Hypoglycemia
Meals
Therapeutics
Safety
Hypoglycemic Agents
insulin glulisine
Population

Keywords

  • Glycated haemoglobin A
  • Insulin glulisine
  • Type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Kawamori, R., Iwamoto, Y., Kadowaki, T., Iwasaki, M., Kim, S. W., Woo, J. T., ... Yoon, K. H. (2009). Effects of insulin glulisine as mono- or add-on therapy in patients with type 2 diabetes mellitus. Diabetes, Obesity and Metabolism, 11(9), 900-909. https://doi.org/10.1111/j.1463-1326.2009.01088.x

Effects of insulin glulisine as mono- or add-on therapy in patients with type 2 diabetes mellitus. / Kawamori, Ryuzo; Iwamoto, Y.; Kadowaki, T.; Iwasaki, M.; Kim, S. W.; Woo, J. T.; Baik, Sei-Hyun; Yoon, K. H.

In: Diabetes, Obesity and Metabolism, Vol. 11, No. 9, 02.09.2009, p. 900-909.

Research output: Contribution to journalArticle

Kawamori, Ryuzo ; Iwamoto, Y. ; Kadowaki, T. ; Iwasaki, M. ; Kim, S. W. ; Woo, J. T. ; Baik, Sei-Hyun ; Yoon, K. H. / Effects of insulin glulisine as mono- or add-on therapy in patients with type 2 diabetes mellitus. In: Diabetes, Obesity and Metabolism. 2009 ; Vol. 11, No. 9. pp. 900-909.
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TY - JOUR

T1 - Effects of insulin glulisine as mono- or add-on therapy in patients with type 2 diabetes mellitus

AU - Kawamori, Ryuzo

AU - Iwamoto, Y.

AU - Kadowaki, T.

AU - Iwasaki, M.

AU - Kim, S. W.

AU - Woo, J. T.

AU - Baik, Sei-Hyun

AU - Yoon, K. H.

PY - 2009/9/2

Y1 - 2009/9/2

N2 - Aim: To evaluate the safety and efficacy of insulin glulisine (glulisine) with and without oral antidiabetic drugs (OAD; sulphonylurea or sulphonylurea + biguanide) relative to that of OAD alone in Japanese and Korean patients with inadequately controlled type 2 diabetes mellitus (T2DM). Methods: In an open, randomized, parallel-group, comparative, controlled trial, 387 patients were randomized and treated with glulisine + OAD (n = 130), glulisine monotherapy (n = 127) or OAD only (n = 130) for 16 weeks. Glulisine was self-injected subcutaneously three times daily (0-15 minutes before meals) at a starting dose of ≥0.2 U/kg/day. Patients titrated the glulisine dose to achieve a 2-h postprandial plasma glucose (2h-PPG) level of 7.1-9.5 mmol/l (128-172 mg/dl) by administering at least one additional unit at each appropriate meal time if the 2h-PPG level was > 9.5 and < 11.1 mmol/l (> 172 and < 200 mg/dl) and by administering at least two additional units if the 2h-PPG level was ≥ 11.1 mmol/l (≥ 200 mg/dl). Therapy with OAD was continued at the stable baseline regimen. The primary efficacy endpoint was change in haemoglobin A1c (HbA1c) from baseline to endpoint in the intention-to-treat population. Results: At baseline, therapy with OAD was a sulphonylurea only and a sulphonylurea + a biguanide in approximately 24 and 76% of patients respectively. Both glulisine groups had larger reductions in adjusted mean HbA1c than the OAD-only group (glulisine + OAD, -2.07%; glulisine monotherapy, -1.25%; OAD only, -0.61%). Superiority of glulisine + OAD and glulisine monotherapy vs. OAD only was shown by differences in adjusted mean HbA1c change from baseline values of -1.46% (p < 0.0001) and -0.64% (p < 0.0001) respectively. Both glulisine groups had better 2h-PPG control than the OAD-only group. Mean daily glulisine doses increased from baseline to endpoint (glulisine + OAD, 13.3-22.5 U; glulisine monotherapy, 14.2-38.0 U). The rate of all symptomatic hypoglycaemia events per patient-year in the entire treatment phase was 11.9 in the glulisine + OAD group, 8.8 in the glulisine monotherapy group and 1.7 in the OAD-only group. There was only one event of severe hypoglycaemia, which occurred in the glulisine + OAD group. Efficacy and safety were similar in Japanese and Korean subpopulations. Conclusions: Both glulisine + OAD and glulisine monotherapy were well tolerated and effective for Japanese and Korean patients with T2DM mellitus inadequately controlled by OAD therapy alone.

AB - Aim: To evaluate the safety and efficacy of insulin glulisine (glulisine) with and without oral antidiabetic drugs (OAD; sulphonylurea or sulphonylurea + biguanide) relative to that of OAD alone in Japanese and Korean patients with inadequately controlled type 2 diabetes mellitus (T2DM). Methods: In an open, randomized, parallel-group, comparative, controlled trial, 387 patients were randomized and treated with glulisine + OAD (n = 130), glulisine monotherapy (n = 127) or OAD only (n = 130) for 16 weeks. Glulisine was self-injected subcutaneously three times daily (0-15 minutes before meals) at a starting dose of ≥0.2 U/kg/day. Patients titrated the glulisine dose to achieve a 2-h postprandial plasma glucose (2h-PPG) level of 7.1-9.5 mmol/l (128-172 mg/dl) by administering at least one additional unit at each appropriate meal time if the 2h-PPG level was > 9.5 and < 11.1 mmol/l (> 172 and < 200 mg/dl) and by administering at least two additional units if the 2h-PPG level was ≥ 11.1 mmol/l (≥ 200 mg/dl). Therapy with OAD was continued at the stable baseline regimen. The primary efficacy endpoint was change in haemoglobin A1c (HbA1c) from baseline to endpoint in the intention-to-treat population. Results: At baseline, therapy with OAD was a sulphonylurea only and a sulphonylurea + a biguanide in approximately 24 and 76% of patients respectively. Both glulisine groups had larger reductions in adjusted mean HbA1c than the OAD-only group (glulisine + OAD, -2.07%; glulisine monotherapy, -1.25%; OAD only, -0.61%). Superiority of glulisine + OAD and glulisine monotherapy vs. OAD only was shown by differences in adjusted mean HbA1c change from baseline values of -1.46% (p < 0.0001) and -0.64% (p < 0.0001) respectively. Both glulisine groups had better 2h-PPG control than the OAD-only group. Mean daily glulisine doses increased from baseline to endpoint (glulisine + OAD, 13.3-22.5 U; glulisine monotherapy, 14.2-38.0 U). The rate of all symptomatic hypoglycaemia events per patient-year in the entire treatment phase was 11.9 in the glulisine + OAD group, 8.8 in the glulisine monotherapy group and 1.7 in the OAD-only group. There was only one event of severe hypoglycaemia, which occurred in the glulisine + OAD group. Efficacy and safety were similar in Japanese and Korean subpopulations. Conclusions: Both glulisine + OAD and glulisine monotherapy were well tolerated and effective for Japanese and Korean patients with T2DM mellitus inadequately controlled by OAD therapy alone.

KW - Glycated haemoglobin A

KW - Insulin glulisine

KW - Type 2 diabetes

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