Abstract | AIMS: METHODS: A post-hoc analysis was performed using data from 3 randomized phase 3 trials (AWARD-2,-4,-5; patients with GADA assessment) which were part of the dulaglutide clinical development programme in T2D. LADA patients were identified by GADA ≥5 IU/mL (ELISA). Changes in HbA1c during 12 months of treatment with dulaglutide or comparator were analysed using mixed-effect model repeated measures. RESULTS: Of 2466 adults tested for GADA ( dulaglutide, 1710; glargine, 298; sitagliptin, 294; placebo, 164), 2278 (92.4%) were GADA-negative and 188 (7.6%) were GADA-positive, including 58 GADA-high patients (> 200 IU/mL) and 130 GADA-low patients (≤200 and ≥5 IU/mL). Overall, baseline parameters were comparable between the groups. Dulaglutide resulted in comparable HbA1c reductions in GADA-negative (LS mean change [95%CI], -1.09% [-1.15, -1.03]) and GADA-positive patients (-0.94% [-1.15, -0.72]) at 12 months. HbA1c reductions were numerically, but not statistically, significantly larger in GADA-low patients (-1.02% [-1.26, -0.78]) vs GADA-high patients (-0.72% [-1.21,-0.24]) at 12 months. Similar outcomes were observed at 3 and 6 months. CONCLUSIONS: These data are the first to indicate that dulaglutide was effective in reducing HbA1c in LADA patients.
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Authors | Paolo Pozzilli, Richard D Leslie, Anne L Peters, Raffaella Buzzetti, Sudha S Shankar, Zvonko Milicevic, Imre Pavo, Jeremie Lebrec, Sherry Martin, Nanette C Schloot |
Journal | Diabetes, obesity & metabolism
(Diabetes Obes Metab)
Vol. 20
Issue 6
Pg. 1490-1498
(06 2018)
ISSN: 1463-1326 [Electronic] England |
PMID | 29377522
(Publication Type: Clinical Trial, Phase III, Comparative Study, Equivalence Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2018 John Wiley & Sons Ltd. |
Chemical References |
- Blood Glucose
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Immunoglobulin Fc Fragments
- Recombinant Fusion Proteins
- Insulin Glargine
- Glucagon-Like Peptides
- Sitagliptin Phosphate
- dulaglutide
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Topics |
- Blood Glucose
(metabolism)
- Double-Blind Method
- Female
- Glucagon-Like Peptides
(administration & dosage, adverse effects, analogs & derivatives)
- Glycated Hemoglobin
(drug effects, metabolism)
- Humans
- Hypoglycemic Agents
(administration & dosage, adverse effects)
- Immunoglobulin Fc Fragments
(administration & dosage, adverse effects)
- Insulin Glargine
(administration & dosage, adverse effects)
- Latent Autoimmune Diabetes in Adults
(blood, drug therapy)
- Male
- Middle Aged
- Recombinant Fusion Proteins
(administration & dosage, adverse effects)
- Sitagliptin Phosphate
(administration & dosage, adverse effects)
- Treatment Outcome
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