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
- Author:
Yu Mi KANG
1
;
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
Author Information
- Publication Type:Multicenter Study
- Keywords: Diabetes mellitus, type 2; Insulin glargine; Safety
- MeSH: Blood Glucose; Body Weight; Body Weight Changes; Diabetes Mellitus, Type 2; Fasting; Hemoglobin A, Glycosylated; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin Glargine; Insulin; Metformin; Morinda
- From:Diabetes & Metabolism Journal 2019;43(4):432-446
- CountryRepublic of Korea
- Language:English
- 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.
