Clinical Trials

At MannKind, our commitment to clinical trials underscores our unwavering dedication to the well-being and safety of patients, along with our unrelenting pursuit of medical innovation. By dedicating substantial time, resources and expertise to the meticulous execution of rigorous clinical trials, we firmly uphold the highest standards of scientific integrity.

Purpose

Purpose

Clinical trials lie at the heart of MannKind’s pursuit to transform medical potential into tangible progress. Each trial illuminates the path toward more effective treatments and therapies. Through meticulous testing and observation, focused on ensuring safety, we uncover the insights that shape medical breakthroughs. At MannKind, our commitment to clinical trials echoes our commitment to humanity, as we work tirelessly to elevate healthcare standards and pave the way for a safer, healthier, and more equitable future.

INFLO-1 Phase 1b, is a randomized, double-blind, placebo-controlled study of Nintedanib DPI in patients with idiopathic pulmonary fibrosis (IPF). The trial consists of multiple ascending doses with the primary objective to evaluate safety, tolerability, and pharmacokinetics of Nintedanib DPI in patients with IPF.

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INHALE-1st is a single-arm, multi-center, clinical study evaluating the safety and efficacy of inhaled insulin in combination with basal insulin (BI) for youth ages 10 to under 18 who have been newly diagnosed with stage 3 type 1 diabetes. The study will also look at how satisfied participants and their parents or legally authorized representatives are with using inhaled insulin plus BI as part of their treatment plan. All participants will use inhaled insulin + BI and will be followed for 13 weeks during the main phase of the study. Those who wish to continue may choose to enter an optional extension phase for up to an additional 26 weeks.

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INHALE-1 is a Phase 3, randomized controlled trial in children and teenagers aged 4-17 with type 1 or type 2 diabetes to evaluate the efficacy and safety of inhaled insulin in combination with basal insulin (BI) versus multiple daily injections of rapid acting insulin in combination with BI.

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Endocrine Scientific Advisory Board

TB
Thomas C. Blevins, MD, ECNU, FACE, FNLA
  • Endocrinologist at Texas Diabetes and Endocrinology (Austin)
BB
Bruce W. Bode, MD, FACE
  • Diabetes specialist, president and CEO of Atlanta Diabetes Associates (Atlanta)
  • Clinical Associate Professor in the Department of Medicine at Emory University
AC
Anders L Carlson, MD
  • Investigator for the International Diabetes Center at Park Nicollet (Minneapolis)
  • Associate Professor at the University of Minnesota Medical School
KC
Kristin Castorino, D.O., BC-ADM
  • Vice President, Clinical Research and Senior Investigator at Sansum Diabetes Research Institute (Santa Barbara, CA)
  • Attending Physician at Santa Barbara County Health Care Center
EC
Eda Cengiz, MD, MHS
  • Professor of Pediatrics at the University of California San Francisco School of Medicine (San Francisco)
  • Benioff UCSF Professor in Children’s Health
  • Director of the UCSF Pediatric Diabetes Program
GG
George Grunberger, MD, FACP, FACE
  • Chairman of Grunberger Diabetes & Endocrinology (Bloomfield Hills, MI)
  • Founder and Chief Medical Officer of HFWL COMPANY
  • Clinical Professor of Internal Medicine and of Molecular Medicine & Genetics at Wayne State University School of Medicine
  • Professor of Internal Medicine at Oakland University William Beaumont School of Medicine
  • Visiting Professor at First Faculty of Medicine at Charles University in Prague (Czech Republic)
MH
Michael Haller, MD, MS-CI
  • Professor and Chief of Pediatric Endocrinology at the University of Florida (Gainesville, FL)
KH
Korey Hood, PhD
  • Professor & Behavioral Scientist at Stanford University
  • Founder of DiabetesWise
DK
Davida Kruger, MSN, APN-BC, BC-ADM
  • Certified nurse practitioner at Henry Ford Health System (Detroit)
  • Division of Endocrinology, Diabetes, Bone and mineral disease
  • Director of Clinical Research
  • Supervisor Advanced Practice Providers
KL
Kashif Latif, MD
  • Medical Director and Principal Investigator for AM Diabetes and Endocrinology Center (Bartlett, TN)
JM
Janet B. McGill, MD, MA, FACE, FACP
  • Professor of Medicine in the Division of Endocrinology, Metabolism and Lipid Research at Washington University School of Medicine (St. Louis)
  • Attending Physical at Barnes-Jewish Hospital
GS
Gary Scheiner, MS, CDCES
  • Owner and Clinical Director of Integrated Diabetes Services (Wynnewood, PA)
AV
Amy M. Valent, D.O., M.C.R.
  • Associate Professor in the Division of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology at Oregon Health & Science University
  • Medical Director, OHSU Diabetes and Pregnancy Program
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