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Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi 1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26-week, open-label, multicentre study: The LixiLan JP-O2 randomized clinical trial.
Diabetes Obes Metab · 2020
Last updated 2026-05-28In a 26-week study of 521 Japanese adults with type 2 diabetes not well controlled by oral drugs, those who took the fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) saw their blood sugar control improve more—an average drop of 1.40% in HbA1c—than those who took insulin glargine alone, who saw a 0.76% drop. A larger share of the iGlarLixi group reached an HbA1c below 7% (71.5% vs 38.5%), and they gained about 1 kg less weight on average, with no increase in low blood sugar events compared to the insulin-only group.
AI summary of the abstract below.
| Journal | Diabetes Obes Metab, 2020 |
|---|---|
| Citations | 37 |
| Relative citation ratio | 1.77 |
| NIH percentile | 70 |
| Molecules | lixisenatide |
| Conditions studied | Type 2 Diabetes |
Abstract
AIMS: To assess efficacy and safety of 26-week treatment with insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) compared with insulin glargine U100 (iGlar) in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).
MATERIALS AND METHODS: This phase 3, multicentre, open-label, 1:1 randomized, parallel-group study compared efficacy of iGlarLixi and iGlar in patients with T2DM, HbA1c of ≥7.5% to ≤9.5% and fasting plasma glucose ≤10.0 mmol/L (180 mg/dL). The primary endpoint was change in HbA1c from baseline to week 26.
RESULTS: Patients were randomized to iGlarLixi (n = 260) or iGlar (n = 261) (mean age 59.7 years, baseline BMI 26.04 kg/m , and HbA1c 8.04% [64.4 mmol/mol]). HbA1c reduction was significantly greater with iGlarLixi (-1.40% [-15.3 mmol/mol]) than with iGlar (-0.76% [-8.3 mmol/mol]). Significantly more iGlarLixi patients reached HbA1c <7% at week 26 (71.5% vs 38.5%, P < .0001), with significantly lower weight gain (LS mean difference -1.06 kg, P < .0001). Documented symptomatic hypoglycemia (plasma glucose ≤3.9 mmol/L [70 mg/dL]) was recorded in 14.2% of patients with iGlarLixi and 12.3% with iGlar. No severe hypoglycemia was reported in either group. Other than the expected gastrointestinal issues associated with glucagon-like peptide 1 receptor agonists, we found no major difference in the incidence of TEAEs.
CONCLUSIONS: HbA1c reduction was significantly greater with iGlarLixi than with iGlar; significantly more patients achieved HbA1c <7%, with no additional risk of hypoglycemia and without weight gain. iGlarLixi (1:1) provided an effective treatment option for Japanese patients with T2DM inadequately controlled on OADs. Clinical Trial Number: NCT02752828.
Verbatim abstract via PubMed 32291880 ↗
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