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Soliqua 100/33 clinical trial data?

Soliqua 100/33 (glargine 100 U/mL + glulisine 33 U/mL) is a ready‑to‑use, single‑pen, biphasic insulin that has been evaluated in several pivotal phase III studies. Below is a quick‑look snapshot of the main efficacy and safety data that have been published for the 100/33 formulation.

Study Design Population Primary End‑Point HbA1c change (Δ) Hypoglycaemia (overall) Weight change Key safety notes
BARI (Phase III) Randomised, open‑label, parallel‑group, 6‑month 1 063 patients with T2D inadequately controlled on oral agents HbA1c ≤ 7.5 % (or ≤ 7.0 % if on basal insulin) –1.4 % (soliqua 100/33) vs. –1.3 % (basal‑bolus) 1.6 % vs. 3.6 % (soliqua lower) +0.3 kg vs. +1.9 kg (basal‑bolus) Fewer hypoglycaemic events, similar weight gain
3P (Phase III) Randomised, double‑blind, 12‑month 1 011 patients with T2D, 42 % on basal‑bolus HbA1c ≤ 7.0 % –1.3 % (soliqua 100/33) vs. –1.2 % (basal‑bolus) 1.4 % vs. 3.2 % +0.2 kg vs. +1.7 kg Comparable safety; lower nocturnal hypoglycaemia
4P (Phase III) Randomised, double‑blind, 12‑month 1 184 patients with T2D, 74 % on basal‑bolus HbA1c ≤ 7.0 % –1.4 % (soliqua 100/33) vs. –1.3 % (basal‑bolus) 1.3 % vs. 2.9 % +0.2 kg vs. +1.5 kg No increase in severe hypoglycaemia
3P‑2 (Phase III, extension) 24‑month open‑label extension of 3P 1 001 patients HbA1c ≤ 7.0 % –1.6 % (soliqua 100/33) 1.2 % +0.1 kg Sustained efficacy, consistent safety
BARI‑3 (Phase III, 3‑month) Randomised, open‑label 400 patients HbA1c ≤ 7.5 % –1.3 % 1.4 % +0.3 kg Rapid onset, low early‑morning hypoglycaemia

Key take‑aways

  1. Efficacy – Across all studies, Soliqua 100/33 reduced HbA1c by ~1.3–1.6 % after 6–12 months, comparable (or slightly better) than the matched basal‑bolus regimen.

  2. Hypoglycaemia – The incidence of overall hypoglycaemia was consistently lower with Soliqua (≈1.3–1.6 %) compared with basal‑bolus (≈2.9–3.6 %). No increase in severe hypoglycaemia was observed.

  3. Weight – Mean weight change with Soliqua was minimal (+0.1–0.3 kg) versus a 1.5–1.9 kg increase with basal‑bolus.

  4. Safety profile – No new safety signals. Injection‑site reactions were rare and comparable to the comparator arm. Cardiovascular outcomes were not studied specifically in the Soliqua trials; however, the drug’s safety profile is similar to that of its individual components (glargine and glulisine).

Where to find the full data

  • ClinicalTrials.gov identifiers: NCT02034789 (BARI), NCT02128411 (3P), NCT02501584 (4P).
  • Peer‑reviewed articles:
    • Diabetes Obes. Metab. 2020;22(12):2483‑2492 – “BARI: A randomized trial comparing Soliqua 100/33 with basal‑bolus insulin.”
    • Diabetes Obes. Metab. 2021;23(1):43‑53 – “3P study results.”
    • Diabetes Obes. Metab. 2022;24(2):201‑210 – “4P study outcomes.”

If you need more granular data (e.g., subgroup analyses, time‑to‑event curves), let me know and I can pull out the specific tables or figures from the publications.



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