Daily, Long-Acting Oral Insulin Tablet Provides Comparable Glycemic Control to Insulin Glargine Injection in Patients with Type 2 Diabetes

SAN DIEGO , June 13, 2017 /PRNewswire-USNewswire/ -- A long-acting, oral insulin tablet has been found to safely improve glycemic control as effectively as the common, injected insulin glargine in people with Type 2 diabetes, according to the study, "Efficacy and Safety of Oral Basal Insulin: Eight-Week Feasibility Study in People with Type 2 Diabetes (T2DM)," presented today at the American Diabetes Association's 77th Scientific Sessions^® at the San Diego Convention Center. Safe and effective oral insulin has been a long-sought after treatment option in diabetes research. As an alternative to routine insulin injections, an easy-to-take oral insulin tablet has the potential to increase patients' medication compliance and may facilitate earlier initiation of insulin therapy.

The study evaluated the effectiveness and safety of OI338GT, an oral insulin tablet, by comparing it to injectable insulin glargine. The study included 50 patients with type 2 diabetes, average age of 61 years and who had never taken any type of insulin. The patients had A1C levels ranging from 7 to 10 percent, while on metformin alone or in combination with other oral diabetes medications. The patients were randomized 1:1 to receive a once daily treatment tablet of OI338GT, or an injection of insulin, glargine U100 (IGlar), once daily for a period of eight weeks. The trial was fashioned as a "double-blind, double-dummy" study, meaning that all patients received one injection and one tablet a day, only one of which contained insulin. To enable participants to achieve a fasting plasma glucose in the target range of 80-126 mg/dL, doses of both insulins were gradually increased once weekly on an individualized basis until no additional therapeutic benefit was seen.

The results showed that both the oral insulin tablet and injectable insulin glargine substantially improved blood glucose levels and other efficacy parameters, with no significant differences between the two insulins at eight weeks. Patients' A1C levels at baseline were compared to their levels at the end of treatment, at eight weeks. The patients in the OI338GT group had an average baseline A1C of 8.1, and an average ending A1C of 7.3. Patients in the IGlar group had an average baseline A1C of 8.2, and an average ending A1C of 7.1.

The number of episodes of hypoglycemia (low blood glucose) was limited and similar in both treatment groups, and no severe hypoglycemia occurred. There were seven incidents of treatment-emergent hypoglycemia in six patients in the OI338GT group, and 11 incidents of treatment-emergent hypoglycemia in six patients in the IGlar group. The rate and type of adverse events was similar. No severe adverse events were observed in either treatment group. A total of 68 adverse events were reported in 32 patients (31 adverse events by 15 subjects treated with OI338GT, and 37 adverse events by 17 patients treated with IGlar).

"The results of our feasibility study show for the first time that it's possible to develop, on a small-scale level, therapeutically meaningful insulin in an easy-to-take oral tablet," said study co-author, Karsten Wassermann, PhD, DSc, project vice president of global development at Novo Nordisk A/S. "Oral insulin has long been considered a highly desirable option in diabetes research, potentially freeing patients from continuous injections in favor of an easy-to-take tablet. While these data are highly encouraging, there is a need to optimize the tablet to further increase the insulin bioavailability. Within the scientific community there is an ongoing search for alternative ways to administer insulin so that we can enable diabetes patients to receive insulin without continuously breaking the skin barrier with a needle. The goal is to provide optimal coverage and ease insulin therapy for patients with diabetes, and now, we're one step closer to achieving that vision." 

Further development of this particular oral insulin project has been discontinued by Novo Nordisk because the bioavailability is low and, hence, the required overall investments to produce the OI338GT in quantities for wide public use have been assessed to not be commercially viable. Improvement of technologies involved in the product's development is the focus of ongoing research.

To speak with Dr. Wassermann, please contact the Association's media relations team on-site at the San Diego Convention Center on June 9 - 13, by phone at 619-525-6250 or by email at [email protected].

The American Diabetes Association's 77th Scientific Sessions, to be held June 9-13, 2017, at the San Diego Convention Center, is the world's largest scientific meeting focused on diabetes research, prevention and care. During the five-day meeting, health care professionals have exclusive access to more than 2,500 original research presentations, participate in provocative and engaging exchanges with leading diabetes experts, and can earn Continuing Medical Education (CME) or Continuing Education (CE) credits for educational sessions. The program is grouped into eight interest areas: Acute and Chronic Complications; Behavioral Medicine, Clinical Nutrition, Education and Exercise; Clinical Diabetes/Therapeutics; Epidemiology/Genetics; Immunology/Transplantation; Insulin Action/Molecular Metabolism; Integrated Physiology/Obesity; and Islet Biology/Insulin Secretion. Brenda Montgomery, RN, MSHS, CDE, President of Health Care and Education^[1], will deliver her address on Saturday, June 10, and Alvin C. Powers, MD, President of Medicine and Science, will present his address on Sunday, June 11. Eight abstracts were selected by the Scientific Sessions Meeting Planning Committee to be presented on Tuesday, June 13, in the President's Oral Session. These abstracts represent important research being conducted in the field of diabetes today. In total, the 2017 Scientific Sessions includes 378 abstracts in 49 oral sessions; 2,152 poster presentations including 50 moderated poster discussions; and 360 published-only abstracts. Join the Scientific Sessions conversation on Twitter, #2017ADA. 

About the American Diabetes Association
More than 29 million Americans have diabetes, and every 23 seconds another person is diagnosed with diabetes. The American Diabetes Association (Association) is the global authority on diabetes and since 1940 has been committed to its mission to prevent and cure diabetes and to improve the lives of all people affected by diabetes. To tackle this global public health crisis, the Association drives discovery in research to treat, manage and prevent all types of diabetes, as well as to search for cures; raises voice to the urgency of the diabetes epidemic; and provides support and advocacy for people living with diabetes, those at risk of developing diabetes and the health care professionals who serve them. For more information, please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit diabetes.org. Information from both of these sources is available in English and Spanish. Find us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn). 

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Efficacy and Safety of Oral Basal Insulin: Eight-Week Feasibility Study in People with Type 2 Diabetes (T2DM)

77th Scientific Sessions
News Briefing: Novel Therapies, Monday, June 12, 1:15 p.m. PT

Oral Presentation: ADA Presidents Oral Session
Location: Ballroom 20C
Session Time: Tuesday, June 13, 2017, 9:45 - 11:45 a.m.

Authors: LEONA PLUM-MÖRSCHEL, TIM HEISE, ERIC ZIJLSTRA, KARSTEN LYBY, KARSTEN WASSERMANN, LISE BRØNDSTED, INGE BIRK HALBERG, Mainz, Germany, Neuss, Germany, Søborg, Denmark

Oral insulin 338 formulated into a GIPET^® I tablet (OI338GT) is a basal, acylated insulin analog with a half-life of ~70 hours. We investigated efficacy and safety of OI338GT in comparison to subcutaneous insulin glargine U100 (IGlar) in 50 insulin naïve T2DM subjects (mean±SD age 61±7 years, BMI 30.5±3.7 kg/m²) insufficiently controlled (HbA_1c 7-10%) on metformin alone or in combination with other oral agents. Patients were randomized 1:1 to OI338GT or IGlar once daily for 8 weeks in a double-blind, double-dummy fashion as add-on to existing metformin with or without DPP-4 inhibitor. Insulin doses were uptitrated weekly on an individualized basis aided by a pre-specified algorithm aiming at achieving fasting plasma glucose (FPG) in the target range of 80-126 mg/dL. Both treatments substantially improved glycemic control as indicated by FPG (primary endpoint), HbA1c and fructosamine with no significant differences between treatments at 8 weeks (Table). C-peptide was comparable at end of treatment (EOT). The incidence of treatment-emergent hypoglycemia was low (OI338GT: 7 events in 6 subjects, IGlar: 11 events in 6 subjects). No severe hypoglycemia occurred. The rate of adverse events was similar. In conclusion, this study demonstrated for the first time that an oral basal insulin safely improves glycemic control to a similar extent as does IGlar.

Author Disclosures:  L. Plum-Mörschel: None. T. Heise: Advisory Panel; Author; Novo Nordisk A/S. Research Support; Author; ADOCIA, Biocon, Dance Biopharm, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Julphar, MedImmune, LLC., Mylan, Nordic Bioscience, Novo Nordisk A/S, Poxel SA, Roche Diagnostics, Saniona, Sanofi, Senseonics, Skyepharma PLC, Zealand Pharma A/S. Speaker's Bureau; Author; Eli Lilly and Company, Novo Nordisk A/S. E. Zijlstra: Speaker's Bureau; Author; Novo Nordisk A/S, Roche Diabetes Care. K. Lyby: Employee; Author; Novo Nordisk A/S. Stock/Shareholder; Author; Novo Nordisk A/S. K. Wassermann: Employee; Author; Novo Nordisk A/S. Stock/Shareholder; Author; Novo Nordisk A/S. L. Brøndsted: Employee; Author; Novo Nordisk A/S. Stock/Shareholder; Author; Novo Nordisk A/S. I. Birk Halberg: Employee; Author; Novo Nordisk A/S. Stock/Shareholder; Author; Novo Nordisk A/S.

^[1] Disclosures for Brenda Montgomery. Employer: AstraZeneca Pharmaceuticals. Montgomery's role as President, Health Care & Education of the American Diabetes Association (Association) is a voluntary position to which she was elected by the members of the Association in 2015. She continues to recuse herself from any and all discussions, decisions or votes that have or could be perceived as having a conflict of interest with her employer. 

SOURCE American Diabetes Association

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