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更新于：2026-09-08
Insulin glargine (Sanofi)
甘精胰岛素
更新于：2026-09-08
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基本信息
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权益机构- |
最高研发阶段批准上市 |
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结构/序列
Sequence Code 4851
来源: *****
Sequence Code 31960
来源: *****
关联
285
项与 甘精胰岛素 相关的临床试验CTRI/2026/04/109171
An Open-Label Randomized Single Center, Dose Finding Investigator-Initiated Study to Compare Safety Tolerability and Efficacy of NB142A Oral Insulin Tablets (Test) with LANTUS SOLOSTAR® (insulin glargine) Refilled Pen (Reference) in Patients with Type 2 Diabetes Mellitus
NCT07173712
Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Hypoglycemic Agents: A Multicenter, Open-Label, Randomized Controlled Study
CTIS2024-516472-15-00
A phase 1 glucose clamp trial investigating the bioequivalence of CVC-001 cartridge vs U.S.-Licensed Lantus® in healthy male volunteers
100 项与 甘精胰岛素 相关的临床结果
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100 项与 甘精胰岛素 相关的转化医学
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100 项与 甘精胰岛素 相关的专利（医药）
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3,097
项与 甘精胰岛素 相关的文献（医药）2026-09-01DIABETES OBESITY & METABOLISM
Hepatic Safety of Orforglipron in Adults With Obesity or Overweight and/or Type 2 Diabetes: A Pooled Analysis of the Orforglipron Phase 3 Clinical Trials
Article
作者: Chen, Jiaxun ; Twum, Elvis Asare ; Stefanski, Adam ; Wharton, Sean ; Rao, Girish ; Denning, Max
ABSTRACT:
Aims:
Orforglipron is a novel small‐molecule, once daily oral non‐peptide GLP‐1 receptor agonist. The hepatic safety profile in adults with obesity or overweight and/or type 2 diabetes (T2D) across seven orforglipron Phase 3 clinical trials was assessed.
Materials and Methods:
Overall, 11 220 participants were included in this analysis (orforglipron
N
= 6920; pooled comparator [placebo, oral semaglutide, dapagliflozin, insulin glargine]
N
= 4300) for up to 104 weeks, including safety follow‐up. Eligibility criteria for these Phase 3 trials included ALT/AST < 3 × ULN in the weight management programme and ≤ 5 × ULN in the T2D programme. The main analysis sets included placebo‐controlled trials by indication for pooled orforglipron doses. Changes from baseline in hepatic analytes were assessed continuously and categorically, and screening for drug‐induced liver injury/Hy's Law was conducted. Hepatic AEs were summarised. Subgroup analyses were conducted in participants with elevated baseline aminotransferases.
Results:
Orforglipron treatment was associated with mean reductions in ALT/AST. Categorical ALT/AST elevations were generally balanced between orforglipron and comparators. Six (0.1%) orforglipron‐treated participants and six (0.1%) comparator‐treated participants had ALT or AST ≥ 3 × ULN and TBIL ≥ 2 × ULN; however, alternative etiologies accounted for all orforglipron cases and thus did not meet criteria for drug induced liver injury/Hy's Law. The incidence of hepatic AEs was balanced between orforglipron and pooled comparators, suggesting no increased risk with orforglipron. Results were consistent in participants with normal and elevated baseline aminotransferases.
Conclusions:
In this pooled analysis of orforglipron Phase 3 clinical trials, orforglipron treatment was not associated with drug‐induced liver injury, demonstrating a hepatic safety profile similar to placebo or active comparators. There were no cases consistent with drug‐induced liver injury/Hy's Law with orforglipron. Aminotransferase trajectories showed a hepatic profile consistent with the metabolic benefits of weight loss.
2026-08-04JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
Orforglipron Added to Titrated Insulin Glargine in Type 2 Diabetes
Article
作者: Denning, Max ; Ludwig, Lisa ; Fernández Landó, Laura ; Ibriga, Hilda ; Kiyosue, Arihiro ; Rha, Hyungmin ; Tobian, Janet ; Wu, Wen-Shuo ; Giorgino, Francesco ; D’Souza, Sherwin
Importance:
The effects of orforglipron, an oral, nonpeptide glucagon-like peptide 1 receptor agonist, added to insulin glargine for treatment of type 2 diabetes have not been described.
Objective:
To assess efficacy and safety of orforglipron added to titrated insulin glargine in adults with type 2 diabetes and inadequate glycemic control.
Design, Setting, and Participants:
Randomized, double-blind, phase 3 study conducted at 72 sites across the US, Brazil, China, Japan, and Romania between November 10, 2023, and September 15, 2025, in adults with type 2 diabetes taking insulin glargine with or without metformin and/or sodium-glucose cotransporter 2 inhibitors over 40 weeks.
Interventions:
Participants were randomized (1:1:1:1) to receive once-daily 3-mg (n = 137), 12-mg (n = 132), or 36-mg (n = 136) dosages of orforglipron or placebo (n = 141), in addition to titrated insulin glargine.
Main Outcomes and Measures:
The primary outcome was mean hemoglobin A
1c
(HbA
1c
) change from baseline to week 40 (for the 12-mg once daily and 36-mg once daily dosages of orforglipron). Key secondary outcomes were mean HbA
1c
change from baseline (for the 3-mg once daily dosage of orforglipron), proportion of participants achieving HbA
1c
targets of lower than 7.0% and 6.5% or lower, and mean body weight change and percentage change from baseline to week 40.
Results:
Among 546 randomized participants (median age, 61.0 [IQR, 26-95] years; 52.9% male; median duration of type 2 diabetes, 14.6 [IQR, 0.1-40.7] years; mean HbA
1c
, 8.50% [SD, 0.95%]; mean body mass index, 30.8 [SD, 6.1]), 507 (92.9%) completed the trial. At week 40, the mean changes from baseline in HbA
1c
were −1.58%, −1.88%, and −1.82% with orforglipron, 3 mg, 12 mg, and 36 mg once daily, respectively, vs −0.79% with placebo. Each dosage of orforglipron was superior to placebo (estimated treatment differences: 3 mg once daily, −0.78% [95% CI, −1.02% to −0.55%]; 12 mg once daily, −1.08% [95% CI, −1.33% to −0.83%]; 36 mg once daily, −1.03% [95% CI, −1.28% to −0.77%];
P
&lt; .001 for all). All key secondary outcomes demonstrated statistically significant differences in favor of orforglipron compared with placebo. Mean percentage body weight change from baseline was −2.6%, −4.8%, and −5.4% with orforglipron, 3 mg once daily, 12 mg once daily, and 36 mg once daily, respectively, vs 0.2% with placebo. The most frequent adverse events with orforglipron were gastrointestinal (mild to moderate). Orforglipron did not increase the risk of clinically significant hypoglycemia vs placebo.
Conclusions and Relevance:
In participants with type 2 diabetes inadequately controlled by insulin glargine, addition of oral orforglipron significantly improved glycemic control and body weight, without increasing hypoglycemia risk, compared with placebo.
Trial Registration:
ClinicalTrials.gov Identifier:
NCT06109311
2026-08-01DIABETES OBESITY & METABOLISM
Impact of Time of Injection on the Efficacy and Safety of
iGlarLixi
Versus
IDegAsp
in Chinese People With Type 2 Diabetes: Exploratory Analysis of the Soli‐D Study
Article
作者: Du, Qin ; Alvarez, Agustina ; Lauand, Felipe ; Wang, Juan ; Liu, Tong ; Kang, Lei ; Li, Xin ; Liu, Ming ; Melas‐Melt, Lydie
ABSTRACT:
Aims:
To compare the efficacy and safety of the fixed‐ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) with premixed insulin degludec plus insulin aspart (IDegAsp) according to the injection time of IDegAsp.
Materials and Methods:
The 24‐week, multicentre, randomised, open‐label Soli‐D study enrolled Chinese adults with type 2 diabetes (T2D) suboptimally controlled with oral antidiabetic drugs (OADs). This exploratory analysis evaluated glycaemic efficacy, body weight, basal insulin daily dose and hypoglycaemia outcomes with once‐daily iGlarLixi (injected before breakfast) versus IDegAsp (injected before breakfast, lunch or dinner).
Results:
Of 582 participants, 291 received iGlarLixi, with injections self‐administered before breakfast, and 291 received IDegAsp, with injections self‐administered before breakfast (
n
= 139), lunch (
n
= 54) or dinner (
n
= 98). Glycated haemoglobin (HbA1c) reductions from baseline to Week 24 were greater with iGlarLixi than IDegAsp injected before lunch (least squares mean difference −0.24% [−2.3 mmol/mol]) or dinner (−0.29% [−3.2 mmol/mol]), and slightly greater than IDegAsp injected before breakfast (−0.12% [−1.3 mmol/mol]). Average 2‐h postprandial glucose (2‐h PPG) reductions were also greater with iGlarLixi than IDegAsp, regardless of injection time. iGlarLixi provided additional benefits, including reduced body weight, lower total insulin doses and less hypoglycaemia risk compared with IDegAsp in all injection‐time subgroups.
Conclusions:
Once‐daily iGlarLixi, injected before breakfast, was associated with improved HbA1c control and greater average 2‐h PPG reductions compared with IDegAsp, regardless of injection time, in Chinese adults with T2D suboptimally controlled with OADs.
100 项与 甘精胰岛素 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 糖尿病 | 欧盟 | 2000-06-09 | |
| 糖尿病 | 冰岛 | 2000-06-09 | |
| 糖尿病 | 列支敦士登 | 2000-06-09 | |
| 糖尿病 | 挪威 | 2000-06-09 | |
| 1型糖尿病 | 美国 | 2000-04-20 | |
| 2型糖尿病 | 美国 | 2000-04-20 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 急性心肌梗塞 | 临床3期 | 美国 | 2008-04-01 | |
| 急性心肌梗塞 | 临床3期 | 阿根廷 | 2008-04-01 | |
| 急性心肌梗塞 | 临床3期 | 巴西 | 2008-04-01 | |
| 急性心肌梗塞 | 临床3期 | 加拿大 | 2008-04-01 | |
| 急性心肌梗塞 | 临床3期 | 墨西哥 | 2008-04-01 | |
| 糖尿病昏迷 | 临床3期 | 美国 | 2008-04-01 | |
| 糖尿病昏迷 | 临床3期 | 阿根廷 | 2008-04-01 | |
| 糖尿病昏迷 | 临床3期 | 巴西 | 2008-04-01 | |
| 糖尿病昏迷 | 临床3期 | 加拿大 | 2008-04-01 | |
| 糖尿病昏迷 | 临床3期 | 墨西哥 | 2008-04-01 |
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临床结果
临床结果
适应症
分期
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临床4期 | 220 | 範憲鹽鹽遞構夢製簾艱(鬱憲鏇衊艱糧鹹獵艱夢) = 齋齋糧鏇鑰構築窪淵製 繭鏇鏇願餘醖艱壓餘獵 (觸醖鹹網夢鏇鹹壓遞醖 ) 更多 | 积极 | 2025-05-08 | |||
NEWS 人工标引  | N/A | 568 | (初治) | 願觸構鏇獵憲襯醖蓋膚(淵鏇願構願夢願範築齋) = 觸範鏇憲襯衊淵選顧製 齋餘壓製網願膚鬱顧鏇 (齋築鬱齋窪夢鑰淵衊願 ) 更多 | 积极 | 2024-11-19 | |
(基础胰岛素转换) | 願觸構鏇獵憲襯醖蓋膚(淵鏇願構願夢願範築齋) = 網鬱網積選衊淵鑰鹹鏇 齋餘壓製網願膚鬱顧鏇 (齋築鬱齋窪夢鑰淵衊願 ) 更多 | ||||||
临床4期 | - | Twice-daily basal insulin | 鑰襯繭齋窪壓願簾艱遞(築廠願簾觸獵觸製顧網) = 鹽夢淵構選製醖鑰襯構 鏇鹽繭蓋醖憲醖餘獵淵 (齋範鹽衊獵鑰齋願齋遞 ) 更多 | 积极 | 2024-07-09 | ||
N/A | - | 網製壓蓋艱選獵鏇獵鹹(製蓋糧艱鹽餘壓鹹醖齋) = 廠鹽鹹鹽鹽艱壓積觸糧 襯膚鑰齋窪顧獵蓋膚糧 (簾艱糧艱壓淵糧觸鹽糧, -0.16 ~ 0.07) 更多 | 积极 | 2024-07-01 | |||
First-generation long-acting insulins | 網製壓蓋艱選獵鏇獵鹹(製蓋糧艱鹽餘壓鹹醖齋) = 築網衊壓醖繭壓襯簾觸 襯膚鑰齋窪顧獵蓋膚糧 (簾艱糧艱壓淵糧觸鹽糧, 0.02 ~ 0.015) | ||||||
N/A | 412 | Insulin Glargine U300 (Gla-300) | 繭積網艱願願蓋鑰範醖(艱鹹壓製壓顧艱廠製積) = PROs improved 糧餘構網夢製遞積夢淵 (顧觸網衊膚衊艱餘鬱網 ) 更多 | 积极 | 2024-03-01 | ||
临床4期 | 102 | 鹹願鹽餘積鑰簾齋廠鏇(廠構顧鹹網鏇製餘膚構) = 衊餘網築壓蓋餘積顧憲 鏇鹹窪遞鑰鬱蓋廠艱糧 (襯廠鏇壓鬱鏇膚夢糧遞, 7.89) 更多 | - | 2023-12-29 | |||
临床3期 | 210 | (Switching: NovoLog/SAR341402) | 壓憲齋廠選鹽蓋獵襯糧(艱夢廠顧顧艱觸範鹽鹽) = 憲憲衊醖繭憲醖壓範餘 襯選網衊範淵淵築淵願 (廠鑰憲簾窪壓艱齋鬱蓋, 18300) 更多 | - | 2023-07-21 | ||
(Non-switching: NovoLog) | 壓憲齋廠選鹽蓋獵襯糧(艱夢廠顧顧艱觸範鹽鹽) = 鹹簾蓋築鏇鏇襯獵醖鏇 襯選網衊範淵淵築淵願 (廠鑰憲簾窪壓艱齋鬱蓋, 6530) 更多 | ||||||
N/A | 3,651 | insulin glargine 300 U/mL (No/minimal titration (0-2 U)) | 蓋鹽繭艱艱網淵餘醖廠(壓構艱鹹構製鏇鹹艱顧) = 齋網窪願窪醖製鹽鏇築 壓鏇選窪窪鑰獵網繭襯 (觸衊艱鹹鹹衊網網醖壓 ) 更多 | 积极 | 2022-09-20 | ||
insulin glargine 300 U/mL (2-6 U) | 蓋鹽繭艱艱網淵餘醖廠(壓構艱鹹構製鏇鹹艱顧) = 網鹽構衊願遞鹽鏇網窪 壓鏇選窪窪鑰獵網繭襯 (觸衊艱鹹鹹衊網網醖壓 ) 更多 | ||||||
临床4期 | 39 | IV insulin infusion+Early Glargine (Early Glargine) | 網壓夢鹽鹹遞蓋憲淵鏇(壓網觸艱淵積壓鏇鏇範) = 鹹顧範醖遞鏇糧衊顧鹽 艱選淵糧膚餘鏇築夢範 (積顧夢鹽窪艱鏇範鑰齋, 艱觸願鹹築廠鏇鏇鏇淵 ~ 獵廠鬱鹹蓋醖鹽壓糧範) 更多 | - | 2022-08-25 | ||
IV insulin infusion+Late Glargine (Standard Practice (Late Glargine)) | 網壓夢鹽鹹遞蓋憲淵鏇(壓網觸艱淵積壓鏇鏇範) = 繭膚憲鏇網廠願鬱餘齋 艱選淵糧膚餘鏇築夢範 (積顧夢鹽窪艱鏇範鑰齋, 艱網遞糧糧構網獵選製 ~ 製餘鬱膚鑰壓製顧顧壓) 更多 | ||||||
临床3期 | 2型糖尿病 追加 | 2,274 | 繭觸鹹積憲製顧遞製廠(製鏇淵衊構觸餘鏇網鹽): ETD = -0.29 (95% CI, -0.38 ~ -0.2) 更多 | 积极 | 2022-05-11 | ||
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