Diabetes Metab J.  2019 Aug;43(4):432-446. 10.4093/dmj.2018.0092.

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 YM
• Jung CH
• Lee SH
• Kim SW
• Song KH
• Kim SG
• Kim JH
• Cho YM
• Park TS
• Ku BJ
• Koh G
• Kim DM
• Lee BW
• Park JY

• KMID: 2455667
• DOI: http://doi.org/10.4093/dmj.2018.0092

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.

Keyword

Diabetes mellitus, type 2; Insulin glargine; Safety

MeSH Terms

Blood Glucose
Body Weight
Body Weight Changes
Diabetes Mellitus, Type 2*
Fasting
Hemoglobin A, Glycosylated
Humans
Hypoglycemia
Hypoglycemic Agents
Insulin Glargine*
Insulin*
Metformin*
Morinda
Hypoglycemic Agents
Insulin
Insulin Glargine
Metformin

Figure

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  Fig. 1 Patient flow. SU, sulfonylurea; HbA1c, glycosylated hemoglobin.

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  Fig. 2 Mean 7-point self-monitored blood glucose (SMBG) profiles during the study period. 2h-PPG, 2-hour postprandial plasma glucose. aP<0.05.

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