Insulin glargine / lixisenatide (iGlarLixi)
A fixed-ratio pen that combines insulin glargine with the GLP-1 agonist lixisenatide in one daily injection
iGlarLixi is the fixed-ratio combination of insulin glargine, a long-acting basal insulin, and lixisenatide, a GLP-1 receptor agonist. It is sold in the US as Soliqua 100/33, a pen delivering 15 to 60 units a day, each unit carrying both drugs. In trials it lowered HbA1c more than basal insulin alone, usually with weight loss. FDA approved it in November 2016.
What is it?
Basal insulin controls fasting glucose but can cause weight gain and does little for after-meal spikes; a GLP-1 agonist such as lixisenatide slows stomach emptying and blunts those spikes. Putting both in one pen is meant to get the benefits of each with fewer injections. Because the ratio is fixed, raising the dose for more insulin also raises the lixisenatide, which is why the label caps the daily dose at 60 units.
The trial programme, first called LixiLan, compared the combination with its parts. In an early phase 2 trial, HbA1c fell from 8.0% to 6.3% on the combination against 6.5% on insulin glargine alone. Pooling seven randomised trials, it lowered HbA1c 0.5% more than glargine and weight about 1.2 kg more. In SoliMix, in people already on basal insulin, it matched a premixed insulin for HbA1c while beating it on weight, with a 1.9 kg difference, and in trials in Chinese adults it outperformed both insulin glargine and insulin degludec-aspart.
Much of the newer evidence is about simplification. People switched from twice-daily premixed insulin lowered HbA1c by 1.2% and lost weight; a randomised phase 4 trial and observational studies have moved people off multiple daily injections onto the single daily pen. In well-controlled older patients, switching held HbA1c steady while insulin doses and the risk of hypoglycaemia fell. In Japan, people switching from multiple daily injections reported better quality of life at 24 weeks despite a small rise in HbA1c.
In routine US practice, 1,685 people starting it lowered HbA1c by about a point over two years without gaining weight, and in insulin-naive adults continuous glucose monitoring showed time in range rising by about a quarter of the day within 16 weeks.
According to the Soliqua 100/33 label, it is injected once a day within the hour before the first meal, and any previous basal insulin or GLP-1 agonist is stopped first. People new to basal insulin or on less than 30 units start at 15 units, those on 30 to 60 units start at 30, and the dose is titrated to fasting glucose up to 60 units. It should not be combined with another GLP-1 agonist, is not for diabetic ketoacidosis, and has not been studied with mealtime insulin.
Mechanism of Action
iGlarLixi combines basal insulin glargine with the GLP-1 agonist lixisenatide in a fixed ratio, one pen for fasting and after-meal glucose.
Basal insulin
Insulin glargine provides steady background insulin, mainly lowering fasting glucose.
GLP-1 receptor
Lixisenatide slows gastric emptying and blunts post-meal glucose and glucagon.
Fixed ratio
Each unit carries 1 unit of glargine and about 0.33 µg of lixisenatide, so the two rise together.
Published Research
These are randomised trials of the combination, read from their PubMed abstracts.
Phase 2: LixiLan vs insulin glargine on metformin
At 24 weeks HbA1c fell from 8.0% to 6.3% with the combination and to 6.5% with glargine, showing non-inferiority and superiority; 84% and 78% reached HbA1c below 7%.
SoliMix: vs premixed insulin in basal-insulin users
HbA1c fell 1.3% with iGlarLixi and 1.1% with BIAsp 30 over 26 weeks, meeting non-inferiority, and body weight differed by 1.9 kg in favour of iGlarLixi.
Chinese adults on basal insulin: vs insulin glargine
Among 426 participants, HbA1c fell to 6.7% on iGlarLixi against 7.4% on glargine, and 63.3% against 29.9% reached HbA1c below 7%.
vs insulin degludec-aspart in Chinese adults
At 24 weeks iGlarLixi was non-inferior and superior for HbA1c (difference -0.20%), reduced body weight by 1.49 kg relative to the comparator, and had lower hypoglycaemia rates.
De-intensifying from multiple daily injections
In 90 people switched from basal-bolus insulin, HbA1c change was similar to staying on multiple daily injections, while body weight fell by 4.19 kg more with iGlarLixi.
Time in range in insulin-naive adults
In 124 insulin-naive adults with HbA1c around 10.2%, 16 weeks of iGlarLixi raised continuous-glucose time in range by 26.2 percentage points, with no severe hypoglycaemia.
Soli-SWITCH: from premixed insulin
In 162 people switched from premixed insulin, mostly twice-daily, HbA1c fell 1.2% from 8.5% at 24 weeks and weight by 1.0 kg; 37.6% reached HbA1c below 7%.
Two years in US practice
In 1,685 US patients starting iGlarLixi, HbA1c fell from 9.3% to 8.3% over 24 months, weight was stable and hypoglycaemia fell from 16.1 to 11.4 events per 100 person-years.
Simplifying in well-controlled older patients
In patients around 69 with HbA1c 6.4% on complex insulin regimens, switching to iGlarLixi kept HbA1c stable while insulin dose fell by 0.20 IU/kg and hypoglycaemia risk dropped from 50% to 21%.
SIMPLIFY Japan: quality of life
In 61 Japanese adults switched from multiple daily insulin injections to once-daily iGlarLixi, diabetes quality-of-life scores rose 10.8 points at 24 weeks, with greater treatment satisfaction and less anxiety, despite a small HbA1c increase.
Against insulin glargine: 7 trials
Across 7 randomised trials of 4,155 people, iGlarLixi lowered HbA1c 0.50% more than insulin glargine and weight 1.17 kg more, and roughly doubled the chance of reaching HbA1c below 6.5%.
Dosing Data
Soliqua 100/33 is injected once daily within the hour before the first meal, dosed in units of insulin glargine, and titrated to fasting glucose.
Educational information, not medical advice. Each dose above is tagged with its source: an approved label, a published human study, animal data, or amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.
Side Effects & Contraindications
Reported Side Effects
From the Soliqua 100/33 label and the trials above.
Contraindications & Cautions
From the label; a clinician decides.
Legal Status
iGlarLixi is an FDA-approved prescription medicine.
Frequently Asked Questions
?What is iGlarLixi?
A once-daily injection combining insulin glargine and lixisenatide in a fixed ratio, sold in the US as Soliqua 100/33 for adults with type 2 diabetes.
?How does it compare with insulin alone?
In trials it lowered HbA1c more than insulin glargine alone and usually with weight loss rather than gain, at the cost of more gastrointestinal side effects.
?How is it dosed?
Once a day within an hour before the first meal, from 15 to 60 units; the maximum of 60 units contains 20 mcg of lixisenatide.
References
- [fda-pi] Sanofi-Aventis U.S. SOLIQUA 100/33 (insulin glargine and lixisenatide injection), US prescribing information: indication, dosing (15-60 units once daily, maximum 60 units), limitations of use, lixisenatide half-life about 3 hours. DailyMed version effective March 18, 2026; read September 30, 2026.
- [pubmed] Rosenstock J, et al. "Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Lixisenatide and Insulin Glargine, Versus Insulin Glargine in Type 2 Diabetes Inadequately Controlled on Metformin Monotherapy: The LixiLan Proof-of-Concept Randomized Trial." Diabetes Care, 2016;39(9):1579-86. PMID: 27284114.
- [pubmed] Rosenstock J, et al. "Advancing Therapy in Suboptimally Controlled Basal Insulin-Treated Type 2 Diabetes: Clinical Outcomes With iGlarLixi Versus Premix BIAsp 30 in the SoliMix Randomized Controlled Trial." Diabetes Care, 2021;44(10):2361-70. PMID: 34183429.
- [pubmed] Yuan X, et al. "Improved glycaemic control and weight benefit with iGlarLixi versus insulin glargine 100 U/mL in Chinese people with type 2 diabetes advancing their therapy from basal insulin plus oral antihyperglycaemic drugs: Results from the LixiLan-L-CN randomized controlled trial." Diabetes Obes Metab, 2022;24(11):2182-2191. PMID: 35762489.
- [pubmed] Liu M, et al. "The efficacy and safety of iGlarLixi versus IDegAsp in Chinese people with type 2 diabetes suboptimally controlled with oral antidiabetic drugs: The Soli-D randomized controlled trial." Diabetes Obes Metab, 2024;26(9):3791-3800. PMID: 38922731.
- [pubmed] Novodvorský P, et al. "Insulin therapy DE-intensificAtion with iGlarLixi: A phase 4, open-label, parallel-group randomised controlled trial." Diabetes Obes Metab, 2026;28(3):1817-1825. PMID: 41395661.
- [fda] FDA. Drugs@FDA (openFDA): SOLIQUA 100/33, BLA 208673, approved November 21, 2016. Read September 30, 2026.
- [pubmed] Li J, et al. "Efficacy and safety of iGlarLixi versus insulin glargine in type 2 diabetes: a meta-analysis of randomized controlled trials." Endocrine, 2025;88(3):731-738. PMID: 40011373.
- [pubmed] Frías JP, et al. "Effect of iGlarLixi on continuous glucose monitoring-measured time in range in insulin-naive adults with suboptimally controlled type 2 diabetes." Diabetes Obes Metab, 2025;27(4):2173-2182. PMID: 39905643.
- [clinical-trial] Haluzík M, et al. "Efficacy and safety of switching to iGlarLixi from premixed insulins in people with type 2 diabetes: The Soli-SWITCH study." Diabetes Obes Metab, 2025;27(5):2730-2739. PMID: 40098261.
- [pubmed] Malik RA, et al. "Long-term effectiveness of iGlarLixi treatment in people with type 2 diabetes in the United States: The soli-durability 24-month observational study." Diabetes Obes Metab, 2025;27(10):5487-5497. PMID: 40785322.
- [pubmed] Taybani ZJ, et al. "iGlarlixi for the simplification of more complex insulin regimens in type 2 diabetes patients with good glycaemic control." Front Endocrinol (Lausanne), 2026;17:1906632. PMID: 42698423.
- [pubmed] Ishii H, et al. "Quality of Life in Japanese People with Type 2 Diabetes Switching from Multiple Daily Insulin Injections to Once-Daily iGlarLixi: SIMPLIFY Japan." Diabetes Ther, 2024;15(11):2381-2400. PMID: 39347902.
Sources & Citations
Studies were read from their PubMed abstracts; the Soliqua 100/33 label (revised March 2026) was read September 30 and October 6, 2026.
Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Talk to a licensed clinician about your own situation.