Adding Once-Daily Lixisenatide for Type 2 Diabetes Inadequately Controlled With Newly Initiated and Continuously Titrated Basal Insulin Glargine A 24-Week,

Slides:



Advertisements
Similar presentations
In the name of GOD In the name of GOD.
Advertisements

THE DIABETES PREVENTION PROGRAM RESEARCH GROUP*
Dual Add-on Therapy in Type 2 Diabetes Poorly Controlled With Metformin Monotherapy: A Randomized Double-Blind Trial of Saxagliptin Plus Dapagliflozin.
Journal Club 埼玉医科大学 総合医療センター 内分泌・糖尿病内科 Department of Endocrinology and Diabetes, Saitama Medical Center, Saitama Medical University 松田 昌文 Matsuda, Masafumi.
New Insulin Glargine 300 Units∙mL2-1 Provides a More Even Activity Profile and Prolonged Glycemic Control at Steady State Compared With Insulin Glargine.
Glucagon-Like Peptide 1 Receptor Agonist or Bolus Insulin With Optimized Basal Insulin in Type 2 Diabetes Featured Article: Michaela Diamant, Michael A.
New Insulin Glargine 300 Units/mL Versus Glargine 100 Units/mL in People With Type 2 Diabetes Using Basal and Mealtime Insulin: Glucose Control and Hypoglycemia.
Liraglutide and the Preservation of Pancreatic β-Cell Function in Early Type 2 Diabetes: The LIBRA Trial Featured Article: Ravi Retnakaran, Caroline K.
Efficacy and Safety of Dulaglutide Added Onto Pioglitazone and Metformin Versus Exenatide in Type 2 Diabetes in a Randomized Controlled Trial (AWARD-1)
Improved Glucose Control With Weight Loss, Lower Insulin Doses, and No Increased Hypoglycemia With Empagliflozin Added to Titrated Multiple Daily Injections.
Contrasting Effects of Lixisenatide and Liraglutide on Postprandial Glycemic Control, Gastric Emptying, and Safety Parameters in Patients With Type 2 Diabetes.
Pramlintide Advisory Committee July 26, 2001 Symlin ® Amylin Pharmaceuticals New Drug Application (21-332) Advisory Committee Meeting Bethesda, Maryland.
An Automated Internet Behavioral Weight-Loss Program by Physician Referral: A Randomized Controlled Trial Featured Article: J. Graham Thomas, Tricia M.
Individualizing Targets and Tactics for High- Risk Patients With Type 2 Diabetes Practical lessons from ACCORD and other cardiovascular trials Featured.
Long-Term Efficacy of Dapagliflozin in T2DM Patients Receiving High-Dose Insulin John P.H. Wilding, DM, FRCP

An analysis of early insulin glargine added to metformin with or without sulfonylurea: impact on glycaemic control and hypoglycaemia.
Titrating Insulin to Glycemic Target Judy Bowen, MD CIM Rotation September, 2006.
Consider this Combo: GLP-1 Receptor Agonists and Basal Insulin Matt Heinsen, PharmD PGY2 Pharmacotherapy Resident Butler University & Community Health.
ORIGIN Outcome Reduction with an Initial Glargine Intervention (ORIGIN) Trial Overview Large international randomized controlled trial in patients with.
Basal Bolus: The Strategy for Managing All Diabetes Fall, 2003 Paul Davidson, MD, FACE Atlanta Diabetes Associates Atlanta, Georgia.
Toujeo® and it’s Place in Therapy
Maternal Efficacy and Safety Outcomes in a Randomized, Controlled Trial Comparing Insulin Detemir With NPH Insulin in 310 Pregnant Women With Type 1 Diabetes.
GLP-1 Agonists and DPP-4 Inhibitors How do they work? Part 7.
Patient-directed titration to achieve glycaemic goals in type 2 diabetes using once-daily basal insulin: results of the TITRATE randomized controlled trial.
Journal Club 亀田メディカルセンター 糖尿病内分泌内科 Diabetes and Endocrine Department, Kameda Medical Center 松田 昌文 Matsuda, Masafumi 2007 年 11 月 1 日 8:20-8:50 B 棟8階 カンファレンス室.
Clinical Practice Glycemic Management of Type 2 Diabetes Mellitus Faramarz Ismail-Beigi, M.D., Ph.D. Dr.kalantar N Engl J Med Volume 366(14):
A Diabetes Outcome Progression Trial
New Insulin Formulations Guillermo Umpierrez, MD, FACP, FACE Professor of Medicine Emory University School of Medicine Part 1.
Overnight Closed-Loop Insulin Delivery in Young People With Type 1 Diabetes: A Free- Living, Randomized Clinical Trial Featured Article: Roman Hovorka,
Safety and Efficacy of Sitagliptin Therapy for the Inpatient Management of General Medicine and Surgery Patients With Type 2 Diabetes A pilot, randomized,
Efficacy and Safety of Canaglifozin, a Sodium- Glucose Cotransporter 2 Inhibitor, as Add-on to Insulin in Patients With Type 1 Diabetes Featured Article:
Biphasic insulin aspart 30 + metformin vs once-daily insulin glargine + glimepiride Kann P, Regulski M, Medding J, Ligthelm R A study in people with type.
Sglt-2 insulin Matthews D, Fulcher G, Perkovic V, et al. Ef  cacy and safety of canagliflozin,an inhibitor of sodium glucose co-transporter 2, added.
Canagliflozin Compared With Sitagliptin for Patients With Type 2 Diabetes Who Do Not Have Adequate Glycemic Control With Metformin Plus Sulfonylurea A.
Journal Club 亀田メディカルセンター 糖尿病内分泌内科 Diabetes and Endocrine Department, Kameda Medical Center 松田 昌文 Matsuda, Masafumi 2008 年5月1日 8:20-8:50 B 棟8階 カンファレンス室.
GLP-1 Agonists and DPP-4 Inhibitors How do they work? Part 4.
Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomized open-label controlled trial Yves.
Gerti Tashko, M.D. DM Journal Club 12/16/2010. The use of exenatide with insulin is not FDA approved. The study was designed to evaluate if exenatide.
Featured Article: Wayne H.-H. Sheu, Ira Gantz, Menghui Chen, Shailaja Suryawanshi, Arpana Mirza, Barry J. Goldstein, Keith D. Kaufman, and Samuel S. Engel.
Introduction Subcutaneous insulin absorption is not reproducible and insulin entry directly into the circulation is not linked to glucose sensing Basal.
 Insulin Degludec  Ultra long action  Due to formation of soluble multihexamers at the injection site from which monomers gradually separate and are.
The Primary Glucose-Lowering Effect of Metformin Resides in the Gut, Not the Circulation: Results From Short-term Pharmacokinetic and 12-Week Dose- Ranging.
R2. Sun Hee Park/Prof. Moon Chan Choi
Glycemia Treatment Strategies Used In ACCORD
Key publication slides
Key publication slides
Neal B, et al. Diabetes Care 2015;38:403–411
Cycloset®A Dopamine Receptor Agonist Cycloset® -Bromocriptine: Safety Trial: Post Hoc Analysis of Cumulative Percent MACE Endpoint Bromocriptine (Parlodel)
Program Goals. Inhaled Insulin: Overcoming Past Obstacles With Advances in Understanding.
Diabetes Journal Club Julie Shah.
Examining CV Effects of Basal Insulin Therapy
Sodium-glucose co-transporter 2 (SGLT2) inhibitors work by blocking the reabsorption of filtered glucose in the kidneys. This leads to glucosuria and improved.
Program Goals. What Will the Emerging Basal Insulin Products Mean for My Diabetes Practice?
Athena Philis-Tsimikas, MD  The American Journal of Medicine 
Novel Insulin Combinations: What Does the Primary Care Physician Need to Know?
Integrated Diabetes Care: How Can We Make the Best Use of New Technology?
Injectable Options as Add-Ons to Basal Insulin: Targeting PPG in Type 2 Diabetes Patients.
T2DM, CV Safety, and Efficacy: DPP-4 Inhibitors in focus
Younger Patients With Type 1 Diabetes: Can We Optimize Their Insulin Therapy?
Patient flow chart: the final prospective study population consisted of 521 individuals, 113 on basal insulin and 408 on OADs. *Plausibility: height (130–230 cm),
Mean daily glucose concentration and frequency of hypoglycemia in long-term care residents with type 2 diabetes. Mean daily glucose concentration and frequency.
Receiver operating characteristic analyses showing area under the curves with reference to 2-hour OGTT (A,B) and fasting plasma glucose (C,D). HbA1c, glycated.
Flow of Patients Through Trial
Effect of empagliflozin on efficacy parameters at week 18.
Changes in glycated hemoglobin (HbA1c) levels after 12 weeks’ treatment with lixisenatide (according to dose increase regimen) or placebo. Changes in glycated.
Glycemic control and body weight over 52 weeks.
Insulin Delivery Systems Atlanta Diabetes Associates
Clinical responses to therapy from baseline to week 24 and end point with last observation carried forward (LOCF). Clinical responses to therapy from baseline.
Insulin in Type 2 Diabetes
Cumulative mean numbers of confirmed (plasma glucose ≤3
Presentation transcript:

Adding Once-Daily Lixisenatide for Type 2 Diabetes Inadequately Controlled With Newly Initiated and Continuously Titrated Basal Insulin Glargine A 24-Week, Randomized, Placebo-Controlled Study (GetGoal-Duo 1) Featured Article: Matthew C. Riddle, M.D., Thomas Forst, M.D., Ronnie Aronson, M.D., F.R.C.P.C., F.A.C.E., Leobardo Sauque-Reyna, M.D., Elisabeth Souhami, M.D., Louise Silvestre, M.D., Lin Ping, M.D., Julio Rosenstock, M.D. Diabetes Care Volume 36: September, 2013

STUDY OBJECTIVE When oral therapy for type 2 diabetes is ineffective, adding basal insulin improves glycemic control However, when glycated hemoglobin (HbA1c) remains elevated because of postprandial hyperglycemia, the next therapeutic step is controversial We examined the efficacy and safety of lixisenatide in patients with HbA1c still elevated after initiation of insulin glargine Riddle M. C. et al. Diabetes Care 2013;36:

STUDY DESIGN AND METHODS This double-blind, parallel-group trial enrolled patients with HbA1c of 7–10% despite oral therapy Insulin glargine was added and systematically titrated during a 12-week run-in After the run-in period, candidates with fasting glucose ≤7.8 mmol/L and HbA1c 7–9% were randomized to 20  g lixisenatide or placebo for 24 weeks while insulin titration continued Primary end point was HbA1c change after randomization Riddle M. C. et al. Diabetes Care 2013;36:

RESULTS Randomized population had mean diabetes duration of 9.2 years, BMI 31.8 kg/m2, and daily glargine dosage of 44 units HbA1c had decreased during run-in from 8.6 to 7.6% Adding lixisenatide further reduced HbA1c by 0.71 vs. 0.40% with placebo More participants attained HbA1c <7% with lixisenatide Lixisenatide reduced plasma glucose 2 h after a standardized breakfast and had a favorable effect on body weight Nausea, vomiting, and symptomatic hypoglycemia <3.3 mmol/L were more common with lixisenatide Riddle M. C. et al. Diabetes Care 2013;36:

CONCLUSIONS Adding lixisenatide to insulin glargine improved overall and postprandial hyperglycemia Lixisenatide should be considered as an alternative to prandial insulin for patients not reaching HbA1c goals with recently initiated basal insulin Riddle M. C. et al. Diabetes Care 2013;36: