Multicentre Phase IV Single Arm Clinical Trial to Evaluate the Safety and Efficacy of a Fixed Ratio Combination of Insulin Glargine and Lixisenatide in Adult Patients With Type 2 Diabetes Who Are Sub Optimally Controlled on Oral Anti-hyperglycemic Drugs and/or Basal Insulin/GLP-1 RA

This is an intervention, phase IV, single-arm study to assess the safety and efficacy of iGlarLixi in adult patients with Type 2 diabetes.

Start Date06 Jan 2025

Sponsor / Collaborator

Sanofi

NCT06671587

/ RecruitingPhase 4

A 20-week, Multicenter, Prospective, Parallel-group Treatment, Open-label, 2-Arm, Phase 4, Randomized Study to Evaluate the Efficacy of iGlarLixi Versus Gla-100 on Glycemic Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Chinese Insulin Naïve Patients With Type 2 Diabetes (T2D) Inadequately Controlled With Oral Antidiabetics

This study is an open-label, 1:1 randomized, active-controlled, 2-arm, 20-week treatment duration, parallel-group, multicenter, phase IV study to evaluate the effect of iGlarLixi versus Gla-100 on glycemic control measured as TIR from CGM device in Chinese insulin naïve patients with T2D inadequately controlled with OADs. At the end of the screening period, eligible participants will be randomized to one of two treatment groups (iGlarLixi or Gla-100 group). The randomization (1:1) will be stratified by values of HbA1c at screening (<8.0%, ≥8.0%), and background treatment (metformin only, metformin+SGLT-2i).
Study details include:
* The study duration per participant will be approximately up to 24 weeks.
* The treatment duration will be up to 20 weeks.
* The number of visits will be 14 visits including 9 times of on-site visits and 5 times of phone call visits in total during screening and treatment periods. On-site every 1 week will be from screening till randomization (Week 0), then on site or phone call visit every 2 weeks till Week 12, then every 3 weeks till Week 18, and the End of Treatment visit will be conducted at Week 20. There will be a safety follow-up by a phone call visit (End of Study) in 3 days (-1/+3 days) after the last dose of the treatment.
* Health measurement/Observation: change in TIR as the primary endpoint
* Intervention name: iGlarLixi and Gla-100
* Participant gender: male and female
* Participant age range: adults at least 18 years of age
* Condition/disease: type 2 diabetes
* Study hypothesis: compared to Gla-100, iGlarLixi will demonstrate a superiority therapeutic effect on glycemic control assessed by change in TIR measured with CGM from baseline to Week 20 in the study participants.

Start Date10 Dec 2024

Sponsor / Collaborator

Sanofi

CTRI/2024/10/075222

/ Not yet recruitingPhase 4

A Multicentre Phase IV single arm clinical trial to evaluate the safety and efficacy of a fixed ratio combination of Insulin Glargine and Lixisenatide in adult patients with Type 2 diabetes who are sub optimally controlled on oral anti-hyperglycemic drugs and/or basal Insulin/GLP-1 RA - iGlarLixi Phase 4 study in India

Start Date28 Oct 2024

Sponsor / Collaborator

Sanofi Healthcare India Pvt Ltd.

100 Clinical Results associated with Insulin Glargine/Lixisenatide

100 Translational Medicine associated with Insulin Glargine/Lixisenatide

100 Patents (Medical) associated with Insulin Glargine/Lixisenatide

1,026

Literatures (Medical) associated with Insulin Glargine/Lixisenatide

01 Dec 2025·Current Neurology and Neuroscience Reports

Special Considerations in the Treatment of Idiopathic Intracranial Hypertension

Review

Author: Friedman, Deborah I

PURPOSE OF REVIEW:

To review the management of Idiopathic Intracranial Hypertension (IIH) with co-existing conditions affecting therapy: obesity, sulfa allergy, nephrolithiasis, and pregnancy.

RECENT FINDINGS:

The IIH-WT trial showed that bariatric surgery is currently the most effective method for obese patients with IIH to lose weight, leading to normalization of CSF pressure in many cases. Allergy to sulfonamide antibiotics does not preclude the use of acetazolamide; rather, penicillin allergy or multiple drug allergies are the strongest predictor of a hypersensitivity reaction. Carbonic anhydrase inhibitors should be avoided in individuals with a personal history of nephrolithiasis; the risk of renal stones increases with concomitant use of other medications with the potential for nephrolithiasis. Glucagon-like peptide-1 receptor antagonists (GLP-1RA) are promising non-surgical weight loss options although preliminary studies have not demonstrated considerable impact on papilledema, headache or vision. Women with IIH have high rates of pregnancy complications partly related to obesity. Recommendations for weight gain or loss during gestation are controversial. Recent studies show better outcomes in obese women who maintain or lose weight while pregnant including gestational diabetes, pre-eclampsia and emergency caesarian section. Progress continues in the search for the cause and best treatments for IIH. Larger multicenter trials of GLP-1RA are needed to determine their efficacy.

01 Apr 2025·Journal of the American College of Emergency Physicians Open

A Case of Intussusception With Bowel Obstruction in a Gastric Roux-en-Y Patient Prescribed Semaglutide

Article

Author: Pavuluri, Suresh K ; Toumar, Ahmad ; Duffy, Andrew J

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are increasingly prescribed for glycemic control and weight loss management in type 2 diabetes. Their use, however, is associated with a wide range of gastrointestinal adverse effects like nausea, vomiting, and abdominal discomfort. This case report presents a 59-year-old woman with a previous Roux-en-Y gastric bypass who was prescribed semaglutide, and subsequently developed intussusception with small bowel obstruction and chemical pancreatitis. The patient presented to the emergency department with nausea, vomiting, and epigastric pain. The patient's laboratory and radiographic studies revealed a long segment of small bowel intussusception, resulting in a small bowel obstruction and likely chemical pancreatitis. Laparoscopic surgical intervention was required, ultimately converted to a laparotomy for successful reduction of the intussusception. This case report underscores a potential complication that may be seen in patients prescribed GLP-1RAs with prior gastric Roux-en-Y surgeries. The adverse effect is likely attributable to altered gastrointestinal motility and delayed gastric emptying, mechanisms that may be exacerbated by the combination of bariatric-induced anatomical changes and the pharmacological actions of GLP-1RAs. Given the increasing prevalence of GLP-1RA use, emergency medicine clinicians must remain vigilant for these potential serious adverse effects, particularly in patients with complex gastrointestinal histories to ensure timely diagnosis and intervention.

01 Mar 2025·METABOLISM-CLINICAL AND EXPERIMENTAL

Effect of glucagon-like peptide-1 receptor agonists and co-agonists on body composition: Systematic review and network meta-analysis

Review

Author: Fragakis, Nikolaos ; Mantzoros, Christos S ; Karakasis, Paschalis ; Patoulias, Dimitrios

BACKGROUND AND AIMS:

While glucagon-like peptide-1 receptor agonists (GLP-1RAs) effectively reduce body weight, their impact on lean mass remains uncertain. This meta-analysis evaluated the effects of GLP-1RAs and GLP-1/GIP receptor dual agonists (GLP-1/GIP-RAs) on body composition, focusing on total weight, fat mass, and lean mass in adults with diabetes and/or overweight/obesity.

METHODS:

A systematic search of Medline, Embase, and the Cochrane Library was conducted through November 12, 2024. Data were analyzed using random-effects pairwise and network meta-analyses to compare interventions with placebo or active comparators.

RESULTS:

Twenty-two randomized controlled trials (2258 participants) were included. GLP-1RAs significantly reduced total body weight (MD -3.55 kg, 95 %-CI [-4.81, -2.29]), fat mass (MD -2.95 kg, 95 %-CI [-4.11, -1.79]), and lean mass (MD -0.86 kg, 95 %-CI [-1.30, -0.42]), with lean mass loss comprising approximately 25 % of the total weight loss. However, the relative lean mass, defined as percentage change from baseline, was unaffected. Liraglutide, at 3.0 mg weekly or 1.8 mg daily, was the only GLP-1RA to achieve significant weight reduction without significantly reducing lean mass. Tirzepatide (15 mg weekly) and semaglutide (2.4 mg weekly) were the most effective for weight and fat mass reduction but were among the least effective in preserving lean mass.

CONCLUSIONS:

Potent GLP-1 RAs, such as tirzepatide and semaglutide, demonstrate greater overall weight loss but are associated with a significant reduction in lean mass.

News (Medical) associated with Insulin Glargine/Lixisenatide

14 Jun 2024

·www.pharmaceutical-technology.com

Pre-diabetes rates increase amidst a renaissance for type 2 diabetes research

There are currently six GLP-1RAs available in the UK. Image credit: Shutterstock / KK Stock. England’s National Health Service (NHS) has reported an 18% increase in the number of people with non-diabetic hyperglycaemia – also known as pre-diabetes. The latest National Diabetes Audit shows that 3,615,330 people registered with a GP have pre-diabetes and are at a greater risk of developing type 2 diabetes (T2D). Compared to 2023 figures, this is up by more than half a million patients. The NHS has rolled out a range of programmes and services to curb the proportion of this cohort that are diagnosed with T2D. However, for those who still develop diabetes, a much-changed treatment landscape now exists. Previously, metformin and other anti-hyperglycaemic medications were the only pharmaceutical options for patients with T2D. Metformin is still the first-line treatment of choice for T2D patients due to its efficacy, safety, and cost. Now, the proliferation of glucagon-like peptide-1 receptor agonists (GLP-1RAs), in particular, has transformed diabetes care. These drugs work by mimicking the GLP-1 hormone that is normally released after eating, which stimulates various glycaemic control mechanisms. See Also: FDA grants approval for Alexion’s NMOSD treatment AbbVie signs agreement to acquire Landos Biopharma for $212.5m GLP-1RA options on the NHS There are currently six GLP-1RAs available in the UK. The more popular options are Eli Lilly’s Mounjaro (tirzepatide) and Novo Nordisk ’s Ozempic (semaglutide). Novo Nordisk also markets semaglutide in the oral form as Rybelsus. Other approved treatments include Eli Lilly’s Trulicity (dulaglutide), Novo Nordisk’s Victoza (liraglutide), and Sanofi ’s Lyxumia (lixisenatide), all GLP-1RAs. The sharp rise in uptake of GLP-1RAs has outpaced supply, however, leading to shortages in the NHS earlier this year. Off-label prescribing worsened the shortages, prompting guidance from a Medicines Safety Notice in March telling clinicians to only prescribe the drugs for their licensed indication. At the same time, an increased supply of Rybelsus, and the introduction of Mounjaro in the supply chain have been highlighted by charity Diabetes UK. The shortages are likely expected to last until the end of this year, according to Douglas Twenefour, head of care at Diabetes UK. Twenefour added: “We fully support the instruction that GLP-1 medications should not be prescribed off-label under any circumstances while there is an ongoing shortage impacting people with T2D.” Global pharma scene Novo Nordisk and Eli Lilly, market leaders for GLP-1RAs, are now the two biggest pharmaceutical companies in the world. Novo Nordisk has a market cap of $436bn while Eli Lilly’s market cap is $839.5bn. Their success has meant other players in the industry have been making a push into diabetes – and more broadly weight loss – treatments. AstraZeneca received US Food and Drug Administration (FDA) approval earlier this week for its paediatric type 2 diabetes treatment Farxiga (dapagliflozin). Farxiga, marketed as Forxiga in the EU, is already approved as an adjunct to diet and exercise to improve glycaemic control in adults with T2D. The company signed a deal worth a potential $1.85bn last November to gain an exclusive licence to Eccogene’s T2D pill ECC5004, at the time in the early stages of development. Roche signalled its intent to join the GLP-1RA arena a month later with its acquisition of Carmot Therapeutics for $2.7bn, along with $400m in milestone payments. Pfizer is eying the lucrative metabolic disease market but suffered a setback after its weight loss pill, lotiglipron, caused serious side effects in a Phase IIb trial, causing the company to drop its GLP-1RA candidate . Pfizer will rest its hopes on its other candidate, danuglipron, to take on competitors.

Drug ApprovalAcquisitionPhase 2License out/in

12 Apr 2024

·www.fiercepharma.com

EU regulator finds no link between GLP-1s and suicidal thoughts

The review started after reports of suicidal thoughts and self-harm from two patients on Novo Nordisk's Ozempic and one taking Saxenda. Eight months after the European Medicines Agency (EMA) opened an investigation into a potential link between popular GLP-1 receptor agonists and suicidal thoughts or actions, the agency has determined there is no such association. The review began in July after two cases of suicidal thoughts and one instance of self-harm were reported from Icelandic users of Novo Nordisk’s blockbuster diabetes and obesity treatments. Along with Novo’s semaglutide products (marketed as Ozempic, Rybelsus and Wegovy), and its liraglutide meds (Saxenda and Victoza), the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) looked into the company’s Xultophy. Also included in the probe were Eli Lilly’s Trulicity, AstraZeneca’s Byetta and Bydureon, and Sanofi’s Soliqua and Adlyxin (or Suliqua and Lyxumia in Europe). After asking for further data from the companies in November, the PRAC found that available evidence does not support a casual association between the drugs and suicidal or self-injurious thoughts or actions, according to a Friday release. The committee further analyzed a study based on a vast database of electronic health records, plus a similar one conducted by the EMA that only included type 2 diabetes patients. Regulators also reviewed otherwise “available studies” and post-marketing data. Even after the probe, the companies will “continue to monitor these events closely,” the European regulators noted. In parallel, the FDA has been looking into hundreds of similar reports flagged through its FDA Adverse Event Reporting System (FAERS). In January, the U.S. agency came to the same conclusion of no clear relationship, partly due to the fact that “these events can be influenced by other potential factors,” the FDA wrote. One factor may be the “known relationship between our food and our mood,” president of the Obesity Medicine Association and chief medical officer at weight-inclusive healthcare company knownwell Angela Fitch, M.D., said in an emailed statement. “When we change that relationship—whether with GLP-1s, surgery, or other methods, we need to ensure we monitor patients for mood changes regardless of treatment modality.” The FDA and EMA findings are further backed by a study from Nature Journal, which pulled data from 1.8 million diabetes and obesity patients showing those who were on Novo’s semaglutide were less likely to have suicidal thoughts than patients taking other treatments.

Clinical Study

04 Apr 2024

·firstwordpharma.com

Diabetes drug trial sparks hope GLP-1s could slow Parkinson's progression

GLP-1 agonists have flipped the script when it comes to managing diabetes and obesity, and appear to be making headway on heart health as well. But one small study has now revealed promising results for slowing the progression of motor disability in early Parkinson's disease.A growing body of evidence suggests GLP-1 agonists have neuroprotective properties that could benefit these patients. For example, some studies point to a lower risk of Parkinson's among diabetics treated with GLP-1s or DPP-4 inhibitors, which increase GLP-1 levels. Another consistent physiological finding of GLP-1 receptor activation has been reduced inflammation in the brain, a key pathological process in Parkinson's.A new paper published in the NEJM evaluated Sanofi's diabetes drug lixisenatide, marketed under the trade names Adlyxin in the US and Lyxumia in Europe, in a randomised Phase II trial of 156 patients with early Parkinson's. Subjects had already begun receiving standard therapy and were in the "on-medication" state. The primary endpoint was change from baseline on a 132-point scale measuring motor disability.Small, but significant differenceAt 12 months, patients on lixisenatide experienced less decline in their motor symptoms, with essentially no change in scores on the Movement Disorder Society–Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III. By contrast, those in the placebo group saw their Parkinson's symptoms get worse, with an increase of 3.04 points on MDS-UPDRS, where higher scores reflect greater motor disability. The difference was small, but statistically significant.After a 2-month washout period, the mean MDS-UPDRS motor scores in the "off-medication" state were 17.7 with lixisenatide and 20.6 for placebo; that compares to baseline motor scores of approximately 15 in both groups. Secondary endpoints, which assessed scores at 6 and 12 months on different parts of the MDS-UPDRS scale including non-motor measures, did not differ substantially between the groups."It remains to be determined whether the apparent effect of the drug on motor scores persists with longer exposure and at other stages of Parkinson's disease," the study authors said.Looking beyond motor scoresIn an accompanying editorial, neurologist David Standaert of the University of Alabama's Heersink School of Medicine cautioned against drawing "overly optimistic" conclusions that lixisenatide may have completely prevented disease worsening. However, the difference between the two groups nonetheless "appears genuine and supports an effect of lixisenatide on the symptoms, and potentially the course, of Parkinson's disease," he said.Trial participants did encounter adverse effects of treatment. Researchers aimed to give the highest approved dose of lixisenatide for diabetes, but 36% of patients had side effects that were too severe at that level. Even with a lower dose, many still experienced adverse effects, with 46% reporting nausea and 13% reporting vomiting in the lixisenatide group, compared to 12% and 3%, respectively, in the placebo arm.Standaert suggested the main takeaway of the study is not so much the extent of the motor score change, but what it might signify. "The primary concern of most patients with Parkinson's disease is not their present condition — it is the fear of progression… If a three-point improvement in score on the MDS-UPDRS is the most that can be achieved with lixisenatide, then the value of treatment with the drug may be limited, especially in view of the adverse effects.""On the other hand, if the benefit of lixisenatide is cumulative, adding another three points each year over a period of 5 to 10 years or more, then this could be a truly transformative treatment," he said, adding "the next step is clearly trials of longer duration."

Phase 2Clinical Result

100 Deals associated with Insulin Glargine/Lixisenatide

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10AE54	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Switzerland	Sanofi-Aventis U.S. LLC	16 May 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 1	Phase 1	Japan	Sanofi	01 Sep 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05413369 (SoliD, CTgov)	Phase 3	Diabetes Mellitus, Type 2	582	Insulin glargine/Lixisenatide+SGLT2 inhibitor+Metformin (iGlarLixi)	qmumfmgeut(ravogahjdf) = lrfbebcobs jyqxcgtzem (gzrgtxuehn, 0.05) View more	-	30 Oct 2024
				SGLT2 inhibitor+IDegAsp+Metformin (IDegAsp)	qmumfmgeut(ravogahjdf) = kcxpebhyse jyqxcgtzem (gzrgtxuehn, 0.05) View more
NCT03798080 (LixiLan-L-CN, Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2 \| Hyperglycemia	124	iGlarLixi	ifwgovcbgw(ulfmdneydm) = irtwhialbq awzvhjgamn (rlcwsdrzjo ) View more	Positive	03 Oct 2024
				iGlar	ifwgovcbgw(ulfmdneydm) = fcmawhxgpp awzvhjgamn (rlcwsdrzjo ) View more
NCT05413369 (SoliD, ADA2024) Manual	Phase 3	Diabetes Mellitus, Type 2	582	iGlarLixi	szdsndhzyu(rsdajvdmmp): Difference = -0.20 (95% CI, -0.33 to -0.07), P-Value = <0.001 View more	Non-inferior	21 Jun 2024
				IDegAsp
ADA2024	Not Applicable	Diabetes Mellitus, Type 2	-	iGlarLixi	wazqecdtpw(mvzgfqxovi) = mykoktqjur zcvcqxwxvh (laktzunnyr ) View more	-	14 Jun 2024
				BID PI dosing	wazqecdtpw(mvzgfqxovi) = tpxyatygmm zcvcqxwxvh (laktzunnyr )
ADA2024	Not Applicable	-	-	iGlarLixi	oubgucnesi(zqizorezbs) = qnacduawcr jmlhlsxryd (ozhoxrikrd, -3.4 to 0.75) View more	-	14 Jun 2024
				MDI	oubgucnesi(zqizorezbs) = bsvgelxwna jmlhlsxryd (ozhoxrikrd, -1.2 to 3.3) View more
ADA2024	Not Applicable	Diabetes Mellitus, Type 2	-	iGlarLixi (Insulin Glargine 100 U/ml and Lixisenatide) (BMI ≥30 kg/m2)	olaagzchhg(molpwzdjdw) = low in both groups wjzcuciptv (rbstxkayps ) View more	-	14 Jun 2024
				iGlarLixi (Insulin Glargine 100 U/ml and Lixisenatide) (BMI <30 kg/m2)
ADA2024	Not Applicable	-	-	iGlarLixi	pkngzuhzfi(grrwasnhkx) = ycfivhykli bgbypzygrw (bqyxofckho, 4.3) View more	-	14 Jun 2024
				MDI	pkngzuhzfi(grrwasnhkx) = tqeqsxctoy bgbypzygrw (bqyxofckho, 3.7) View more
ADA2024	Not Applicable	Diabetes Mellitus, Type 2	-	iGlarLixi	jdfwjjnimw(qrwdidpaly) = koeokgrizh nbwcfuttdc (twbjbraicl, 1.18 - 1.71)	-	14 Jun 2024
NCT05114590 (374-P, ADA2024)	Phase 4	Diabetes Mellitus, Type 2	124	Sulfonylurea (SU) users	eiplgvdjbl(bpqomfbdzg) = only reported by SU users oemprsojxa (sqwbkmddeu ) View more	Positive	14 Jun 2024
ADA2024	Not Applicable	Diabetes Mellitus, Type 2	-	iGlarLixi	heeniqkeoh(bjsmghexhj) = dtjszjegty mqiowvpkdd (mblboymshx ) View more	-	14 Jun 2024

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