X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development Research & Development

Merck’s MK-1293 Shows Statistical Equivalence to Lantus

Yuvraj_pawp by Yuvraj_pawp
13th June 2016
in Research & Development

Merck announced results from two Phase 3 studies evaluating MK-1293, Merck’s investigational, follow-on biologic* insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes.

 

In both studies, MK-1293 achieved its primary endpoint by demonstrating non-inferiority in change from baseline A1C (a measure of average blood glucose) and similar safety to Lantus® (insulin glargine)** after 24 weeks in patients with type 1 and type 2 diabetes. Furthermore, in both studies, MK-1293 met its pre-specified secondary efficacy endpoints of statistical A1C equivalence to Lantus, a measure used to show that an investigational treatment is similar, within an acceptable range, to a current therapy.

 

“It is encouraging to see that the investigational agent MK-1293 met its primary and secondary endpoints,” said Philip Home, D.M., D.Phil, professor of diabetes medicine, Newcastle University, United Kingdom. “These data, together with other clinical studies of its time-action profile, suggest that Merck’s insulin glargine, if approved, could help provide glycemic control in appropriate patients with type 1 and type 2 diabetes.”

 

MK-1293 has the same amino acid sequence as Lantus, the originator insulin glargine. The development of MK-1293 builds on an agreement between Merck and Samsung Bioepis established in February 2013 to develop and commercialize multiple biosimilar candidates across different therapeutic areas. Under the terms of a subsequent 2014 agreement, Merck is responsible for the clinical development, manufacturing and, if approved, commercialization of MK-1293. Samsung Bioepis is partially funding its development.

 

“The investigational agent MK-1293 represents Merck’s entry into insulin therapeutics and into treatments that may be useful for patients with type 1 diabetes, and we are pleased with these Phase 3 results,” said Peter Stein, M.D., vice president, late stage development, diabetes and endocrinology, Merck. “As a follow-on biologic, MK-1293 has the potential to offer a treatment option for pediatric and adult patients with type 1 diabetes and for adults with type 2 diabetes who use basal insulin to help control their glucose levels.”

 

MK-1293 in Patients with Type 1 Diabetes (296-OR)
The Phase 3, randomized, active-controlled, open-label trial assessed the efficacy and safety of MK-1293 (n= 245) compared with Lantus (n=263) in patients with type 1 diabetes. The primary efficacy endpoint was non-inferiority of change from baseline A1C at week 24. At baseline, patients had an A1C level equal to or less than 11.0 percent and were taking basal and prandial insulin.

 

The primary endpoint of the study was met, demonstrating the non-inferiority of MK-1293 to Lantus in patients with type 1 diabetes. The least-squares mean difference in A1C (MK-1293 minus Lantus) was 0.04 percent (95% CI: -0.11, 0.19), meeting A1C non-inferiority (upper bound of the confidence interval <0.4%) and equivalence (confidence interval within -0.4% and 0.4%) criteria. Basal insulin doses were similar between groups (MK-1293 minus Lantus; difference of -0.7 U/day; 95% CI -2.5, 1.0 U/day).

 

MK-1293 in Patients with Type 2 Diabetes (926-P)

The Phase 3, randomized, active-controlled, open-label trial assessed the efficacy and safety of MK-1293 (n=265) compared to Lantus (n=266) in patients with type 2 diabetes inadequately controlled on diet and exercise alone. The primary efficacy endpoint was non-inferiority of change from baseline A1C at week 24. At baseline, patients had an A1C level equal to or less than 11.0 percent and were eligible for or were taking basal insulin greater than or equal to 10 U/day.

 

MK-1293 met the study’s primary endpoint, demonstrating non-inferiority to Lantus with a least-squares mean difference in A1C (MK-1293 minus Lantus) of 0.03 percent (95% CI: -0.12, 0.18), meeting A1C non-inferiority (upper bound of the confidence interval <0.4%) and equivalence (confidence interval within -0.4% and 0.4%) criteria. Basal insulin doses were similar between groups (MK-1293 minus Lantus; difference of 1.4 U/day; 95% CI -2.2, 4.9 U/day).

 

The primary safety objective was anti-insulin antibody (AIA) development. Similar AIA, including incidence and titers, and similar neutralizing antibody responses were seen between treatment groups. In the study, 29.0 percent of patients receiving Lantus and 34.7 percent being treated with MK-1293, irrespective of AIA status at baseline, had an AIA positive at or before week 24. Additionally, 14.9 percent of patients receiving Lantus and 19.3 percent of patients receiving MK-1293 who were negative of AIA at baseline had an AIA positive at or before week 24.

 

About Merck
For 125 years, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com

 
Contact:
Merck
Media:
Doris Li, 908-246-5701
Kristen Drake, 908-334-4688

 

or
Investor:
Justin Holko, 908-740-1879

Previous Post

Sanofi Announces Positive Phase 3 Results For Investigational Titratable Fixed-Ratio

Next Post

Shire to license investigational gastric drug from Pfizer

Related Posts

Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows
Manufacturing

Commercial Success In New Biopharmaceutical Innovation Era

21st May 2022
Manufacturing

Proteros and AstraZeneca Boost Collaboration Agreement

18th May 2022
SEQENS Makes Multi-Million-Dollar Investment in U.S. R&D Laboratory
Middle East and South Asia

SEQENS Makes Multi-Million-Dollar Investment in U.S. R&D Laboratory

22nd March 2022
Exscientia and Sanofi establish strategic research collaboration to develop AI-driven pipeline of precision-engineered medicines
Press Statements

Exscientia and Sanofi establish strategic research collaboration to develop AI-driven pipeline of precision-engineered medicines

17th January 2022
COVID-19 Impact On Changing Pharma Research And Development
News

COVID-19 Impact On Changing Pharma Research And Development

12th January 2022
immuno-oncology therapies
Drug Development

AbbVie, University of Chicago Extend Research Collaboration to Support Preclinical Oncology Research Through 2025

19th November 2021
Next Post

Shire to license investigational gastric drug from Pfizer

Latest News

FDA Experts Recommend Changing COVID Jab Formulation In Fall
Manufacturing

FDA Experts Recommend Changing COVID Jab Formulation In Fall

30th June 2022
Novartis to acquire The Medicines Company for USD 9.7 bn
Manufacturing

Novartis To Slash 8,000 Jobs To Save $1 Billion By 2024

30th June 2022
How Lag In African COVID-19 Jabs Slowed Its Once Rapid Pace
Manufacturing

How Lag In African COVID-19 Jabs Slowed Its Once Rapid Pace

27th June 2022
Australia Creates A Novel Stem Cell Production Technique
Manufacturing

Australia Creates A Novel Stem Cell Production Technique

27th June 2022
Novartis to acquire The Medicines Company for USD 9.7 bn
Manufacturing

Novartis Promises $250M For Tropical Illnesses, Malaria

27th June 2022
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In