Accepted Article
Correspondence Kelly L. Close, Close Concerns, President. Tel: +4152419500 Email: [email protected]; [email protected]
Diabetes News1 Emily E. REGIER and Kelly L. CLOSE Close Concerns, San Francisco, California, USA
Emily E. Regier and Kelly L. Close are of Close Concerns (http://www.closeconcerns.com), a healthcare information company focused exclusively on diabetes and obesity care. Close Concerns publishes Diabetes Close Up and Closer Look, periodicals that bring together news and insights in these areas. Each quarter, the Journal of Diabetes includes this News feature, in which Regier and Close review the latest developments relevant to researchers and clinicians. Readers of Journal of Diabetes involved in the clinical care of patients with diabetes (including students and educators) may request a complimentary 1-year subscription to Close Concerns’ monthly newsletter, Diabetes Close Up ([email protected]). European Association for the Study of Diabetes 50th Annual Meeting (EASD 2014) EASD 2014, one of the largest diabetes-focused scientific meetings in the world, was held from September 14-19 in Vienna, Austria. The meeting brought together over 18,000 endocrinologists and other healthcare practitioners from over 100 countries and featured oral presentations, symposia, debates, posters, and corporate-sponsored sessions on a broad range of topics in diabetes and obesity. As a major highlight of the meeting, new follow-up data was presented from the ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation) outcomes trial. Dr. Sophia Zoungas (University of Sydney, Sydney, Australia) shared that ADVANCE-ON (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation Post-trial Observational Study)1, the long-term observational follow-up of patients in ADVANCE (which completed in 2007), showed no evidence of a legacy effect of intensive glycemic control on macrovascular endpoints or retinopathy; the only major legacy effect was seen with end-stage kidney disease (HR = 0.54; 95% CI: 0.34-0.85). The hazard ratios and 95% confidence intervals for major macrovascular events, major clinical macrovascular events, and retinal photocoagulation/diabetes-related blindness were 1.00 [0.92-1.08], 0.92 [0.801.05], and 0.97 [0.83-1.13], respectively. These results stand in contrast to the results from the long-term follow-up of the UKPDS (United Kingdom Prospective Diabetes Study), which found both a macrovascular and microvascular legacy effect of intensive control; one potential
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/1753-0407.12235 This article is protected by copyright. All rights reserved.
Accepted Article
explanation is that patients in the UKPDS were younger and more recently diagnosed, whereas patients in ADVANCE were much older and had more longstanding diabetes (average duration of approximately eight years at the initiation of the original ADVANCE trial). Additionally, the duration of the study and follow-up for UKPDS (approximately 20 years total) was greater than that for ADVANCE and ADVANCE-ON (approximately 10 years total).
Dr. Ira Gantz (Merck, Whitehouse Station, NJ, USA) presented the first phase 3 results on Merck’s (Whitehouse Station, NJ, USA) once-weekly DPP-4 inhibitor omarigliptin, which demonstrated a comparable safety and efficacy profile to the company’s once-daily DPP-4 inhibitor Januvia (sitagliptin). The 24-week, non-inferiority trial was conducted in Japanese patients (n = 414) with type 2 diabetes and compared the safety, efficacy, and tolerability of omarigliptin 25 mg to both placebo and sitagliptin 50 mg. Omarigliptin met the 0.3% A1c margin for non-inferiority, with an efficacy profile comparable to that of sitagliptin – both achieved placebo-adjusted A1c reductions of 0.8% from a baseline of 8%. Both agents also significantly reduced two-hour post-meal glucose (-2.35 mmol/L with omarigliptin and -2.51 mmol/L with sitagliptin) and fasting plasma glucose (-1.03 mmol/L with omarigliptin and -1.15 mmol/L with sitagliptin) levels relative to placebo (-0.30 mmol/L and -0.35 mmol/L reductions in post-meal and fasting glucose, respectively) and showed no significant differences with regard to safety. Omarigliptin, like sitagliptin, had a neutral effect on body weight. In one of the best-attended sessions of the conference, Dr. Ralph DeFronzo (University of Texas Health Science Center, San Antonio, TX, USA) presented full 52-week results from a phase 3 trial of Eli Lilly (Indianapolis, IN, USA) and Boehringer Ingelheim’s (Ingelheim am Rhein, Germany) empagliflozin/linagliptin (empa/lina) fixed-dose combination as an add-on to metformin. At one year, both doses of empa/lina (empagliflozin 25 mg/linagliptin 5 mg and empagliflozin 10 mg/ linagliptin 5 mg) achieved significantly greater A1c reductions (1.21% and 1.05%, respectively, from a baseline of 8.0%) than empagliflozin 25 mg (0.64%), empagliflozin 10 mg (0.69%(, or linagliptin 5 mg (0.48%) alone. A poster by Dr. Andrew Lewin (National Research Institute, Los Angeles, CA, USA) et al. presented 52-week results from another phase 3 trial evaluating the same empa/lina combination, but in treatment-naïve type 2 diabetes patients. From a mean baseline of 8%, the high-dose combination (empagliflozin 25 mg/linagliptin 5 mg) achieved a numerically but not statistically significantly greater A1c reduction from baseline than empagliflozin 25 mg alone (1.17% vs. 1.05%; p = 0.176); the combination’s advantage over linagliptin was statistically significant (1.17% vs. 0.52%; p50%. The results were highly statistically significant and particularly notable given that the mealtime insulin dose was reduced by 30% in the pramlintide arms. There were no significant differences between any of the dose ratios. A plot of postprandial glucose showed the most dramatic improvement with the fixed-dose combination 30-120 minutes post-meal (e.g., approximately 155 mg/dL with insulin + pramlintide vs. approximately 260 mg/dL with insulin alone at 60 minutes), though there was no significant difference in glucose levels by three hours post-meal (approximately 260 mg/dl in all groups). A highlight of the conference on the diabetes technology side was the presentation of new data on Abbott’s (Abbott Park, IL, USA) FreeStyle Libre flash glucose monitoring system, which is a new format for patient-friendly glucose monitoring that does not require fingersticks. In a 75patient, 14-day pivotal trial, the factory calibrated FreeStyle Libre system demonstrated an overall mean absolute relative difference (MARD) of 11.4% vs. FreeStyle Precision capillary fingersticks, consistent with previous data (87% of points were in Zone A of the Consensus Error Grid and 13% in Zone B). MARD was lowest on day one (15.7%), improved to 11.9% on day two, and hovered between 10.3% and 11.85 on days 3-14. The study had 13,195 paired FreeStyle Libre-BGM data points (range: 23-498 mg/dL); the MARD was not broken down by glucose range, so accuracy in hypoglycemia is still an unanswered question. If you are interested in receiving the full Close Concerns report on EASD 2014, please email Kelly Close ([email protected]). Company Updates August 12: Sanofi (Paris, France) and MannKind (Valencia, CA, USA) announced a worldwide exclusive licensing agreement for the development and commercialization of MannKind’s inhaled insulin Afrezza (Technosphere inhaled insulin). The companies plan to launch Afrezza in the US in early 2015.
This article is protected by copyright. All rights reserved.
Accepted Article
August 14: Johnson & Johnson (New Brunswick, NJ, USA) announced the US approval of Invokamet, its fixed-dose combination of Invokana (canagliflozin) and metformin. The combination was also approved in the EU on April 28 under the trade name Vokanamet. Invokamet is recommended for twice daily dosing; different versions of the tablet will contain 50 mg or 150 mg doses of canagliflozin and 500 mg or 1,000 mg doses of metformin. It is indicated for type 2 diabetes patients who are not at their glycemic targets with metformin, Invokana, or metformin and Invokana taken as separate tablets. A launch was planned within a week after the product’s approval. August 27: Eli Lilly (Indianapolis, IN, USA) and Boehringer Ingelheim (Ingelheim am Rhein, Germany) announced the US launch of the SGLT-2 inhibitor Jardiance (empagliflozin), following the product’s Food and Drug Administration (FDA) approval on August 1. Jardiance was also approved in Europe on May 23, and a European launch is expected from July-September this year, likely starting with the UK and Germany. September 3: Abbott’s (Abbott Park, IL, USA) 14-day wear, factory calibrated FreeStyle Libre Flash Glucose Monitoring system received a CE Mark; the first launches of the product were slated to take place in France, Germany, Italy, the Netherlands, Spain, Sweden, and the UK. The approved system consists of a touchscreen reader and a small, round coin-sized patch worn on the upper arm; the patch measures glucose every minute in interstitial fluid through a subcutaneous sensor and the reader can be scanned over the sensor to obtain a real-time glucose reading, eighthour trend graph, and glucose rate of change arrow. This format of glucose monitoring was designed to be a patient-friendly intermediate standard self-monitoring of blood glucose (SMBG) and continuous glucose monitoring (CGM). September 7: Eli Lilly (Indianapolis, IN, USA) announced topline results from two phase 3 trials of its novel basal insulin peglispro (PEGylated insulin lispro, or novel basal insulin lispro [BIL]) in patients with type 1 diabetes. The trials, IMAGINE-1 (A Study in Participants With Type 1 Diabetes Mellitus) and IMAGINE-3 (A Study in Patients With Type 1 Diabetes Mellitus), demonstrated superior A1c reductions with BIL compared to Sanofi’s (Paris, France) Lantus (insulin glargine), along with better effects on nocturnal hypoglycemia and weight. Some of the same safety signals that emerged in previous phase 2/3 trials were also seen in these studies, including increases in triglycerides and liver enzymes. In addition, patients treated with BIL experienced significantly more total and daytime hypoglycemia, as well as modest increases in LDL and (in one of the trials) blood pressure. September 8: Hyperion Therapeutics (Brisbane, CA, USA) announced a decision to terminate the development of DiaPep277, its phase 3 “immune intervention therapy” for new onset type 1 diabetes, due to evidence of misconduct by employees of Andromeda Biotech (Yavne, Israel), which Hyperion acquired in June. The implicated employees had allegedly arranged to improperly receive unblinded data from an independent biostatistics firm in order to manipulate the analysis of the phase 3 DIA-AID 1 (Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients) and DIA-AID 2 (Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults) trials. September 9: Mylan (Cecil Township, PA, USA) and Biocon (Bangalore, India) began recruiting participants for two phase 3 trials investigating the companies’ biosimilar insulin glargine formulation. INSTRIDE 1 (Non-inferiority Study to Compare the Efficacy and Safety of Mylan’s Insulin Glargine With Lantus in Type 1 Diabetes Mellitus Patients; n=500) and INSTRIDE 2 (Non-inferiority Study to Compare the Efficacy and Safety of Mylan’s Insulin Glargine With Lantus in Type 2 Diabetes Mellitus Patients; n=600) are both open-label, randomized studies that
This article is protected by copyright. All rights reserved.
Accepted Article
aim to demonstrate non-inferiority compared to Sanofi’s (Paris, France) Lantus (insulin glargine). Both trials have a primary endpoint of change in A1c at 24 weeks, as well as several secondary endpoints including rate of hypoglycemic events. The trials have an estimated completion date of June 2016. September 10: Eli Lilly (Indianapolis, IN, USA) and Boehringer Ingelheim (Ingelheim am Rhein, Germany) announced the European approval of the companies’ biosimilar insulin glargine formulation, formerly known as LY2963016. This product is the first insulin ever approved in Europe under the European Medicines Agency’s biosimilar drug approval pathway. September 18: Novo Nordisk (Bagsvaerd, Denmark) announced the European approval of its GLP-1 agonist/ basal insulin fixed-ratio combination Xultophy (IDegLira; insulin degludec/liraglutide), the first in the class of basal insulin/GLP-1 agonist combinations to reach the market. The product is indicated for the treatment of adults with type 2 diabetes mellitus to improve glycemic control in combination with oral glucose-lowering medications when these alone or combined with basal insulin do not provide adequate glycemic control. The company anticipates a European launch in the first half of 2015. September 18: Eli Lilly (Indianapolis, IN, USA) announced the US approval of its GLP-1 agonist Trulicity (dulaglutide), the first once-weekly GLP-1 agonist available that does not require reconstitution. The company plans to launch the product later in 2014; Trulicity will be available in 0.75 mg and 1.5 mg doses.
Sources: 1. Zoungas S, Chalmers J, Neal B, Billot L, Li Q, Hirakawa Y, Arima H, Monaghan H, Joshi R, Colagiuri S, Cooper ME, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Lisheng L, Mancia G, Marre M, Matthews DR, Mogensen CE, Perkovic V, Poulter N, Rodgers A, Williams B, MacMahon S, Patel A, Woodward M; the ADVANCE-ON Collaborative Group. “Follow-up of Blood-Pressure Lowering and Glucose Control in Type 2 Diabetes.” N Engl J Med. 2014 Sep 19. [Epub ahead of print] PMID: 25234206.
2. Ahrén B, Johnson S, Stewart M, Cirkel D, Yang F, Perry C, Feinglos M. “HARMONY 3: 104Week Randomized, Double-Blind, Placebo- and Active-Controlled Trial Assessing the Efficacy and Safety of Albiglutide Compared With Placebo, Sitagliptin, and Glimepiride in Patients with Type 2 Diabetes Taking Metformin.” Diabetes Care; 37(8): 2141-2148.
This article is protected by copyright. All rights reserved.
Correspondence Kelly L. Close, Close Concerns, President. Tel: +4152419500 Email: [email protected]; [email protected]
Diabetes News1 Emily E. REGIER and Kelly L. CLOSE Close Concerns, San Francisco, California, USA
Emily E. Regier and Kelly L. Close are of Close Concerns (http://www.closeconcerns.com), a healthcare information company focused exclusively on diabetes and obesity care. Close Concerns publishes Diabetes Close Up and Closer Look, periodicals that bring together news and insights in these areas. Each quarter, the Journal of Diabetes includes this News feature, in which Regier and Close review the latest developments relevant to researchers and clinicians. Readers of Journal of Diabetes involved in the clinical care of patients with diabetes (including students and educators) may request a complimentary 1-year subscription to Close Concerns’ monthly newsletter, Diabetes Close Up ([email protected]). European Association for the Study of Diabetes 50th Annual Meeting (EASD 2014) EASD 2014, one of the largest diabetes-focused scientific meetings in the world, was held from September 14-19 in Vienna, Austria. The meeting brought together over 18,000 endocrinologists and other healthcare practitioners from over 100 countries and featured oral presentations, symposia, debates, posters, and corporate-sponsored sessions on a broad range of topics in diabetes and obesity. As a major highlight of the meeting, new follow-up data was presented from the ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation) outcomes trial. Dr. Sophia Zoungas (University of Sydney, Sydney, Australia) shared that ADVANCE-ON (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation Post-trial Observational Study)1, the long-term observational follow-up of patients in ADVANCE (which completed in 2007), showed no evidence of a legacy effect of intensive glycemic control on macrovascular endpoints or retinopathy; the only major legacy effect was seen with end-stage kidney disease (HR = 0.54; 95% CI: 0.34-0.85). The hazard ratios and 95% confidence intervals for major macrovascular events, major clinical macrovascular events, and retinal photocoagulation/diabetes-related blindness were 1.00 [0.92-1.08], 0.92 [0.801.05], and 0.97 [0.83-1.13], respectively. These results stand in contrast to the results from the long-term follow-up of the UKPDS (United Kingdom Prospective Diabetes Study), which found both a macrovascular and microvascular legacy effect of intensive control; one potential
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/1753-0407.12235 This article is protected by copyright. All rights reserved.
Accepted Article
explanation is that patients in the UKPDS were younger and more recently diagnosed, whereas patients in ADVANCE were much older and had more longstanding diabetes (average duration of approximately eight years at the initiation of the original ADVANCE trial). Additionally, the duration of the study and follow-up for UKPDS (approximately 20 years total) was greater than that for ADVANCE and ADVANCE-ON (approximately 10 years total).
Dr. Ira Gantz (Merck, Whitehouse Station, NJ, USA) presented the first phase 3 results on Merck’s (Whitehouse Station, NJ, USA) once-weekly DPP-4 inhibitor omarigliptin, which demonstrated a comparable safety and efficacy profile to the company’s once-daily DPP-4 inhibitor Januvia (sitagliptin). The 24-week, non-inferiority trial was conducted in Japanese patients (n = 414) with type 2 diabetes and compared the safety, efficacy, and tolerability of omarigliptin 25 mg to both placebo and sitagliptin 50 mg. Omarigliptin met the 0.3% A1c margin for non-inferiority, with an efficacy profile comparable to that of sitagliptin – both achieved placebo-adjusted A1c reductions of 0.8% from a baseline of 8%. Both agents also significantly reduced two-hour post-meal glucose (-2.35 mmol/L with omarigliptin and -2.51 mmol/L with sitagliptin) and fasting plasma glucose (-1.03 mmol/L with omarigliptin and -1.15 mmol/L with sitagliptin) levels relative to placebo (-0.30 mmol/L and -0.35 mmol/L reductions in post-meal and fasting glucose, respectively) and showed no significant differences with regard to safety. Omarigliptin, like sitagliptin, had a neutral effect on body weight. In one of the best-attended sessions of the conference, Dr. Ralph DeFronzo (University of Texas Health Science Center, San Antonio, TX, USA) presented full 52-week results from a phase 3 trial of Eli Lilly (Indianapolis, IN, USA) and Boehringer Ingelheim’s (Ingelheim am Rhein, Germany) empagliflozin/linagliptin (empa/lina) fixed-dose combination as an add-on to metformin. At one year, both doses of empa/lina (empagliflozin 25 mg/linagliptin 5 mg and empagliflozin 10 mg/ linagliptin 5 mg) achieved significantly greater A1c reductions (1.21% and 1.05%, respectively, from a baseline of 8.0%) than empagliflozin 25 mg (0.64%), empagliflozin 10 mg (0.69%(, or linagliptin 5 mg (0.48%) alone. A poster by Dr. Andrew Lewin (National Research Institute, Los Angeles, CA, USA) et al. presented 52-week results from another phase 3 trial evaluating the same empa/lina combination, but in treatment-naïve type 2 diabetes patients. From a mean baseline of 8%, the high-dose combination (empagliflozin 25 mg/linagliptin 5 mg) achieved a numerically but not statistically significantly greater A1c reduction from baseline than empagliflozin 25 mg alone (1.17% vs. 1.05%; p = 0.176); the combination’s advantage over linagliptin was statistically significant (1.17% vs. 0.52%; p50%. The results were highly statistically significant and particularly notable given that the mealtime insulin dose was reduced by 30% in the pramlintide arms. There were no significant differences between any of the dose ratios. A plot of postprandial glucose showed the most dramatic improvement with the fixed-dose combination 30-120 minutes post-meal (e.g., approximately 155 mg/dL with insulin + pramlintide vs. approximately 260 mg/dL with insulin alone at 60 minutes), though there was no significant difference in glucose levels by three hours post-meal (approximately 260 mg/dl in all groups). A highlight of the conference on the diabetes technology side was the presentation of new data on Abbott’s (Abbott Park, IL, USA) FreeStyle Libre flash glucose monitoring system, which is a new format for patient-friendly glucose monitoring that does not require fingersticks. In a 75patient, 14-day pivotal trial, the factory calibrated FreeStyle Libre system demonstrated an overall mean absolute relative difference (MARD) of 11.4% vs. FreeStyle Precision capillary fingersticks, consistent with previous data (87% of points were in Zone A of the Consensus Error Grid and 13% in Zone B). MARD was lowest on day one (15.7%), improved to 11.9% on day two, and hovered between 10.3% and 11.85 on days 3-14. The study had 13,195 paired FreeStyle Libre-BGM data points (range: 23-498 mg/dL); the MARD was not broken down by glucose range, so accuracy in hypoglycemia is still an unanswered question. If you are interested in receiving the full Close Concerns report on EASD 2014, please email Kelly Close ([email protected]). Company Updates August 12: Sanofi (Paris, France) and MannKind (Valencia, CA, USA) announced a worldwide exclusive licensing agreement for the development and commercialization of MannKind’s inhaled insulin Afrezza (Technosphere inhaled insulin). The companies plan to launch Afrezza in the US in early 2015.
This article is protected by copyright. All rights reserved.
Accepted Article
August 14: Johnson & Johnson (New Brunswick, NJ, USA) announced the US approval of Invokamet, its fixed-dose combination of Invokana (canagliflozin) and metformin. The combination was also approved in the EU on April 28 under the trade name Vokanamet. Invokamet is recommended for twice daily dosing; different versions of the tablet will contain 50 mg or 150 mg doses of canagliflozin and 500 mg or 1,000 mg doses of metformin. It is indicated for type 2 diabetes patients who are not at their glycemic targets with metformin, Invokana, or metformin and Invokana taken as separate tablets. A launch was planned within a week after the product’s approval. August 27: Eli Lilly (Indianapolis, IN, USA) and Boehringer Ingelheim (Ingelheim am Rhein, Germany) announced the US launch of the SGLT-2 inhibitor Jardiance (empagliflozin), following the product’s Food and Drug Administration (FDA) approval on August 1. Jardiance was also approved in Europe on May 23, and a European launch is expected from July-September this year, likely starting with the UK and Germany. September 3: Abbott’s (Abbott Park, IL, USA) 14-day wear, factory calibrated FreeStyle Libre Flash Glucose Monitoring system received a CE Mark; the first launches of the product were slated to take place in France, Germany, Italy, the Netherlands, Spain, Sweden, and the UK. The approved system consists of a touchscreen reader and a small, round coin-sized patch worn on the upper arm; the patch measures glucose every minute in interstitial fluid through a subcutaneous sensor and the reader can be scanned over the sensor to obtain a real-time glucose reading, eighthour trend graph, and glucose rate of change arrow. This format of glucose monitoring was designed to be a patient-friendly intermediate standard self-monitoring of blood glucose (SMBG) and continuous glucose monitoring (CGM). September 7: Eli Lilly (Indianapolis, IN, USA) announced topline results from two phase 3 trials of its novel basal insulin peglispro (PEGylated insulin lispro, or novel basal insulin lispro [BIL]) in patients with type 1 diabetes. The trials, IMAGINE-1 (A Study in Participants With Type 1 Diabetes Mellitus) and IMAGINE-3 (A Study in Patients With Type 1 Diabetes Mellitus), demonstrated superior A1c reductions with BIL compared to Sanofi’s (Paris, France) Lantus (insulin glargine), along with better effects on nocturnal hypoglycemia and weight. Some of the same safety signals that emerged in previous phase 2/3 trials were also seen in these studies, including increases in triglycerides and liver enzymes. In addition, patients treated with BIL experienced significantly more total and daytime hypoglycemia, as well as modest increases in LDL and (in one of the trials) blood pressure. September 8: Hyperion Therapeutics (Brisbane, CA, USA) announced a decision to terminate the development of DiaPep277, its phase 3 “immune intervention therapy” for new onset type 1 diabetes, due to evidence of misconduct by employees of Andromeda Biotech (Yavne, Israel), which Hyperion acquired in June. The implicated employees had allegedly arranged to improperly receive unblinded data from an independent biostatistics firm in order to manipulate the analysis of the phase 3 DIA-AID 1 (Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients) and DIA-AID 2 (Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults) trials. September 9: Mylan (Cecil Township, PA, USA) and Biocon (Bangalore, India) began recruiting participants for two phase 3 trials investigating the companies’ biosimilar insulin glargine formulation. INSTRIDE 1 (Non-inferiority Study to Compare the Efficacy and Safety of Mylan’s Insulin Glargine With Lantus in Type 1 Diabetes Mellitus Patients; n=500) and INSTRIDE 2 (Non-inferiority Study to Compare the Efficacy and Safety of Mylan’s Insulin Glargine With Lantus in Type 2 Diabetes Mellitus Patients; n=600) are both open-label, randomized studies that
This article is protected by copyright. All rights reserved.
Accepted Article
aim to demonstrate non-inferiority compared to Sanofi’s (Paris, France) Lantus (insulin glargine). Both trials have a primary endpoint of change in A1c at 24 weeks, as well as several secondary endpoints including rate of hypoglycemic events. The trials have an estimated completion date of June 2016. September 10: Eli Lilly (Indianapolis, IN, USA) and Boehringer Ingelheim (Ingelheim am Rhein, Germany) announced the European approval of the companies’ biosimilar insulin glargine formulation, formerly known as LY2963016. This product is the first insulin ever approved in Europe under the European Medicines Agency’s biosimilar drug approval pathway. September 18: Novo Nordisk (Bagsvaerd, Denmark) announced the European approval of its GLP-1 agonist/ basal insulin fixed-ratio combination Xultophy (IDegLira; insulin degludec/liraglutide), the first in the class of basal insulin/GLP-1 agonist combinations to reach the market. The product is indicated for the treatment of adults with type 2 diabetes mellitus to improve glycemic control in combination with oral glucose-lowering medications when these alone or combined with basal insulin do not provide adequate glycemic control. The company anticipates a European launch in the first half of 2015. September 18: Eli Lilly (Indianapolis, IN, USA) announced the US approval of its GLP-1 agonist Trulicity (dulaglutide), the first once-weekly GLP-1 agonist available that does not require reconstitution. The company plans to launch the product later in 2014; Trulicity will be available in 0.75 mg and 1.5 mg doses.
Sources: 1. Zoungas S, Chalmers J, Neal B, Billot L, Li Q, Hirakawa Y, Arima H, Monaghan H, Joshi R, Colagiuri S, Cooper ME, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Lisheng L, Mancia G, Marre M, Matthews DR, Mogensen CE, Perkovic V, Poulter N, Rodgers A, Williams B, MacMahon S, Patel A, Woodward M; the ADVANCE-ON Collaborative Group. “Follow-up of Blood-Pressure Lowering and Glucose Control in Type 2 Diabetes.” N Engl J Med. 2014 Sep 19. [Epub ahead of print] PMID: 25234206.
2. Ahrén B, Johnson S, Stewart M, Cirkel D, Yang F, Perry C, Feinglos M. “HARMONY 3: 104Week Randomized, Double-Blind, Placebo- and Active-Controlled Trial Assessing the Efficacy and Safety of Albiglutide Compared With Placebo, Sitagliptin, and Glimepiride in Patients with Type 2 Diabetes Taking Metformin.” Diabetes Care; 37(8): 2141-2148.
This article is protected by copyright. All rights reserved.
