OR26-4 Liraglutide As Additional Treatment to Insulin in Patients with Type 1 Diabetes Mellitus: A Randomized Clinical Trial

Program: Abstracts - Orals, Poster Preview Presentations, and Posters
Session: OR26-Type 1 and Cystic Fibrosis Related Diabetes: Technology and Peptides
Sunday, June 22, 2014: 11:30 AM-1:00 PM
Presentation Start Time: 12:15 PM
W184 (McCormick Place West Building)

Helmsley Charitable Trust Abstract Awards in Type 1 Diabetes
Nitesh D Kuhadiya, MD, MPH1, Sandeep S Dhindsa, MD, MBBS2, Aditya Mehta3, Antoine Makdissi, MD4, Sartaj Sandhu, MD5, Husam Ghanim, PHD6, Manav Batra5, Ajay Chaudhuri, MBBS, MRCP7, Jeanne Hejna3, Kelly Green5, Natalie Bellini3 and Paresh Dandona, MD, PHD, FRCP, FACP8
1University at Buffalo, Buffalo, NY, 2SUNY at Buffalo, Amherst, NY, 3Suny at Buffalo, 4State Univ of New York at Buffalo, NY, 5SUNY at Buffalo, 6SUNY at Buffalo, Buffalo, NY, 7UB Sch of Med, Williamsville, NY, 8Diabetes Ctr of W NY, Buffalo, NY
We have previously demonstrated that the addition of liraglutide to insulin therapy in patients with type 1 diabetes(T1D) results in an the improvement in glycemic control, weight loss and a reduction in systolic blood pressure(SBP). We have now conducted the first prospectively randomized study investigating effects of liraglutide in T1D. We present an interim analysis of 47 patients that have completed the study (Placebo=14; Liraglutide = 33).  All patients had T1D for at least one year, on insulin therapy and had no detectable c-peptide in plasma (mean BMI: 29±1,mean A1c: 7.55±0.10%, mean age: 46±2 years, mean age of T1D diagnosis: 20±2). They were randomized to receive placebo, 0.6 , 1.2  and 1.8mg of liraglutide daily for 12 weeks. The number of patients receiving 0.6, 1.2 and 1.8mg doses was 10, 13 and 10 respectively (For purposes of this interim analysis, we have combined data on all 23 patients who received 1.2 and 1.8 mg). In combined group (1.2 and 1.8mg), HbA1c fell by 0.5% from 7.62±0.12% to 7.12±0.11%(p<0.0001, p=0.03vs placebo). Daily average blood glucose fell from 174±4 to 164±6mg/dl (p=0.08, p=0.05 vs placebo). Percent time spent between 70 to 160 mg/dl increased from 42±2 to 49±3%(p=0.05) and that between 160-400 mg/dl decreased from 52±2 to 45±3%(p=0.03) with no additional hypoglycemia. The dose of insulin did not alter. There was a reduction in body weight (194±8.5lbs to 184±8.9lbs,p<0.0001 in combined 1.2 and 1.8 mg groups and 165±8 to 158±8, p=0.0006 in 0.6 mg group) and daily carbohydrate intake (163±14g vs 123±15g;p<0.0002 in higher dose groups) over 12 weeks. SBP in 1.8 mg group fell by 9 mm (118±2.8 to 109±3,p=0.03). CRP fell by 18±7%. There was no change in any of these indices in patients treated with the placebo and 0.6 mg liraglutide. This is the first randomised double-blinded placebo controlled clinical trial to show that the addition of 1.2 mg and 1.8 mg of liraglutide to insulin significantly reduced HbA1c, mean blood glucose, blood pressure, body weight, carbohydrate intake and CRP in type 1 diabetes.  Our findings have significant implications for the future treatment of type 1 diabetes.

Nothing to Disclose: NDK, SSD, AM, AM, SS, HG, MB, AC, JH, KG, NB, PD

*Please take note of The Endocrine Society's News Embargo Policy at https://www.endocrine.org/news-room/endo-annual-meeting

Sources of Research Support: This trial was funded by Novo Nordisk.Dr Kuhadiya Nitesh D received funding from Endocrine Fellows Foundation.