Effectiveness and safety of adding basal insulin glargine in patients with type 2 diabetes mellitus exhibiting inadequate response to metformin and DPP-4 inhibitors with or without sulfonylurea

Yu Mi Kang, Chang Hee Jung, Seung Hwan Lee, Sang Wook Kim, Kee Ho Song, Sin Gon Kim, Jae Hyeon Kim, Young Min Cho, Tae Sun Park, Bon Jeong Ku, Gwanpyo Koh, Dol Mi Kim, Byung Wan Lee, Joong Yeol Park

Research output: Contribution to journalArticle

Abstract

Background: We aimed to investigate the effectiveness and safety of adding basal insulin to initiating dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin and/or sulfonylurea (SU) in achieving the target glycosylated hemoglobin (HbA1c) in patients with type 2 diabetes mellitus (T2DM). Methods: This was a single-arm, multicenter, 24-week, open-label, phase 4 study in patients with inadequately controlled (HbA1c ≥7.5%) T2DM despite the use of DPP-4 inhibitor and metformin. A total of 108 patients received insulin glargine while continuing oral antidiabetic drugs (OADs). The primary efficacy endpoint was the percentage of subjects achieving HbA1c ≤7.0%. Other glycemic profiles were also evaluated, and the safety endpoints were adverse events (AEs) and hypoglycemia. Results: The median HbA1c at baseline (8.9%; range, 7.5% to 11.1%) decreased to 7.6% (5.5% to 11.7%) at 24 weeks. Overall, 31.7% subjects (n=33) achieved the target HbA1c level of ≤7.0%. The mean differences in body weight and fasting plasma glucose were 1.2±3.4 kg and 56.0±49.8 mg/dL, respectively. Hypoglycemia was reported in 36 subjects (33.3%, 112 episodes), all of which were fully recovered. There was no serious AE attributed to insulin glargine. Body weight change was significantly different between SU users and nonusers (1.5±2.5 kg vs. –0.9±6.0 kg, P=0.011). Conclusion: The combination add-on therapy of insulin glargine, on metformin and DPP-4 inhibitors with or without SU was safe and efficient in reducing HbA1c levels and thus, is a preferable option in managing T2DM patients exhibiting dysglycemia despite the use of OADs.

Original languageEnglish
Pages (from-to)432-446
Number of pages15
JournalDiabetes and Metabolism Journal
Volume43
Issue number4
DOIs
Publication statusPublished - 2019 Aug 1

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Dipeptidyl-Peptidase IV Inhibitors
Metformin
Type 2 Diabetes Mellitus
Safety
Hypoglycemia
Hypoglycemic Agents
Body Weight Changes
Glycosylated Hemoglobin A
Fasting
Body Weight
Insulin
Glucose
Insulin Glargine

Keywords

  • Diabetes mellitus, type 2
  • Insulin glargine
  • Safety

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism

Cite this

Effectiveness and safety of adding basal insulin glargine in patients with type 2 diabetes mellitus exhibiting inadequate response to metformin and DPP-4 inhibitors with or without sulfonylurea. / Kang, Yu Mi; Jung, Chang Hee; Lee, Seung Hwan; Kim, Sang Wook; Song, Kee Ho; Kim, Sin Gon; Kim, Jae Hyeon; Cho, Young Min; Park, Tae Sun; Ku, Bon Jeong; Koh, Gwanpyo; Kim, Dol Mi; Lee, Byung Wan; Park, Joong Yeol.

In: Diabetes and Metabolism Journal, Vol. 43, No. 4, 01.08.2019, p. 432-446.

Research output: Contribution to journalArticle

Kang, Yu Mi ; Jung, Chang Hee ; Lee, Seung Hwan ; Kim, Sang Wook ; Song, Kee Ho ; Kim, Sin Gon ; Kim, Jae Hyeon ; Cho, Young Min ; Park, Tae Sun ; Ku, Bon Jeong ; Koh, Gwanpyo ; Kim, Dol Mi ; Lee, Byung Wan ; Park, Joong Yeol. / Effectiveness and safety of adding basal insulin glargine in patients with type 2 diabetes mellitus exhibiting inadequate response to metformin and DPP-4 inhibitors with or without sulfonylurea. In: Diabetes and Metabolism Journal. 2019 ; Vol. 43, No. 4. pp. 432-446.
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AU - Kang, Yu Mi

AU - Jung, Chang Hee

AU - Lee, Seung Hwan

AU - Kim, Sang Wook

AU - Song, Kee Ho

AU - Kim, Sin Gon

AU - Kim, Jae Hyeon

AU - Cho, Young Min

AU - Park, Tae Sun

AU - Ku, Bon Jeong

AU - Koh, Gwanpyo

AU - Kim, Dol Mi

AU - Lee, Byung Wan

AU - Park, Joong Yeol

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N2 - Background: We aimed to investigate the effectiveness and safety of adding basal insulin to initiating dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin and/or sulfonylurea (SU) in achieving the target glycosylated hemoglobin (HbA1c) in patients with type 2 diabetes mellitus (T2DM). Methods: This was a single-arm, multicenter, 24-week, open-label, phase 4 study in patients with inadequately controlled (HbA1c ≥7.5%) T2DM despite the use of DPP-4 inhibitor and metformin. A total of 108 patients received insulin glargine while continuing oral antidiabetic drugs (OADs). The primary efficacy endpoint was the percentage of subjects achieving HbA1c ≤7.0%. Other glycemic profiles were also evaluated, and the safety endpoints were adverse events (AEs) and hypoglycemia. Results: The median HbA1c at baseline (8.9%; range, 7.5% to 11.1%) decreased to 7.6% (5.5% to 11.7%) at 24 weeks. Overall, 31.7% subjects (n=33) achieved the target HbA1c level of ≤7.0%. The mean differences in body weight and fasting plasma glucose were 1.2±3.4 kg and 56.0±49.8 mg/dL, respectively. Hypoglycemia was reported in 36 subjects (33.3%, 112 episodes), all of which were fully recovered. There was no serious AE attributed to insulin glargine. Body weight change was significantly different between SU users and nonusers (1.5±2.5 kg vs. –0.9±6.0 kg, P=0.011). Conclusion: The combination add-on therapy of insulin glargine, on metformin and DPP-4 inhibitors with or without SU was safe and efficient in reducing HbA1c levels and thus, is a preferable option in managing T2DM patients exhibiting dysglycemia despite the use of OADs.

AB - Background: We aimed to investigate the effectiveness and safety of adding basal insulin to initiating dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin and/or sulfonylurea (SU) in achieving the target glycosylated hemoglobin (HbA1c) in patients with type 2 diabetes mellitus (T2DM). Methods: This was a single-arm, multicenter, 24-week, open-label, phase 4 study in patients with inadequately controlled (HbA1c ≥7.5%) T2DM despite the use of DPP-4 inhibitor and metformin. A total of 108 patients received insulin glargine while continuing oral antidiabetic drugs (OADs). The primary efficacy endpoint was the percentage of subjects achieving HbA1c ≤7.0%. Other glycemic profiles were also evaluated, and the safety endpoints were adverse events (AEs) and hypoglycemia. Results: The median HbA1c at baseline (8.9%; range, 7.5% to 11.1%) decreased to 7.6% (5.5% to 11.7%) at 24 weeks. Overall, 31.7% subjects (n=33) achieved the target HbA1c level of ≤7.0%. The mean differences in body weight and fasting plasma glucose were 1.2±3.4 kg and 56.0±49.8 mg/dL, respectively. Hypoglycemia was reported in 36 subjects (33.3%, 112 episodes), all of which were fully recovered. There was no serious AE attributed to insulin glargine. Body weight change was significantly different between SU users and nonusers (1.5±2.5 kg vs. –0.9±6.0 kg, P=0.011). Conclusion: The combination add-on therapy of insulin glargine, on metformin and DPP-4 inhibitors with or without SU was safe and efficient in reducing HbA1c levels and thus, is a preferable option in managing T2DM patients exhibiting dysglycemia despite the use of OADs.

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