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1. 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial

Author

Hamann, Andreas, Barakat, Alain, Blüher, Matthias, Linn, Thomas, Mölle, Andrea, Segner, Alexander, Stübler, Petra, Tosch-Sisting, Regina, Pacini, Furio, Santini, Ferruccio, Marchesini, Giulio, Rotella, Carlo Maria, Invitti, Cecilia, Vettor, Roberto, Buscemi, Silvio, Raya, Pedro Mezquita, Freijoo, Felipe Casanueva, de Barbará, Ramón Gomis, Carraro, Raffaele, Bobillo, Enrique Romero, de la Cuesta, Carmen, Farsang, Csaba, Csaszar, Albert, Zahorska-Markiewicz, Barbara, Pupek-Musialik, Danuta, Franek, Edward, Ostrowska, Lucyna, Olszanecka-Glinianowicz, Magdalena, Lalic, Nebojsa, Micic, Dragan, Ludvik, Bernhard, Paulweber, Bernhard, Prager, Rudolf, Scheen, André, Van Gaal, Luc, Astrup, Arne Vernon, Hermansen, Kjeld, Madsbad, Sten, Rissanen, Aila, Nieminen, Sakari, Savolainen, Markku, Krempf, Michel, Romon, Monique, Laville, Martine, Marre, Michel, Mira, Reginald, Finucane, Francis, Veenendaal, Aletha, van Berkum, Frank, Johannsson-Vidarsdóttir, Solrun, Van de Walle, Vivienne, Meesters, Eelco, Hjelmesæth, Jøran, Klemsdal, Tor Ole, Kulseng, Bård, Bach-Kliegel, Birgit, Laederach, Kurt, Villiger, Lukas, Golay, Alain, Bilz, Stefan, Sathyapalan, Thozhukat, Bain, Stephen, Kumar, Sudesh, Le Roux, Carel Wynard, Lean, Michael E.J., McGowan, Barbara, Rehman, Tariq, Wilding, John, Wittert, Gary, Caterson, Ian, Proietto, Joeseph, Prins, John, Neto, Bruno Geloneze, Gross, Jorge Luiz, Chacra, Antonio Roberto, Halpern, Alfredo, de Almeida Suplicy, Henrique, Chow, Francis Chun Chung, Thacker, Hemant P, Chadha, Manoj, Chandalia, Hemaraj, Unnikrishnan, Ambika, Kalra, Sanjay, Deshpande, Neeta, Shunmugavelu, Minakshi, Deshmukh, Vaishali Chetan, Maislos, Maximo, Lieberman, Gabriella Segal, Shimon, Ilan, Stern, Naftali, Nabriski, Dan, Karnieli, Eddy, Shehadeh, Naim, Gonzalez-Galvez, Guillermo, del Rosario Arechavaleta-Granell, Maria, Ortiz, Rafael Margarito Violante, Franco, Guadalupe Morales, Gurieva, Irina, Suplotova, Lyudmila Aleksandrovna, Troshina, Ekaterina, Ruyatkina, Ludmila Aleksandrovna, Voychik, Emma Anatolievna, Martsevich, Sergey, Startseva, Maria A, Seeber, Mary Elizabeth, Badat, Aysha, Ellis, Graham, Altuntas, Yuksel, Guler, Serdar, Ulgen, Ender, Delibasi, Tuncay, Chetty, Tony, Hart, Randy, Janzen, Jeannette, Labonte, Isabelle, Lau, David, Liutkus, Joanne, O'Keefe, Dennis, Padwal, Raj, Ransom, Thomas P.P., Tytus, Richard, Weisnagel, Stanley John, Adler, Jay, Aqua, Keith, Aronoff, Stephen L, Bedel, Gary W., Blevins, Thomas Craig, Blumenau, Joe, Brockmyre, Andrew Peter, Call, Robert S, Canadas, Rafael, Chaykin, Louis B, Cohen, Kenneth, Conrow, Jeffrey Keith, Davis, Matthew G, Downey, H Jackson, Drosman, Steven Richard, Duckor, Steven, Farmer, H. Frank, Farrell, James, Fehnel, Stephen, Finneran, Matthew Patrick, Forbes, Ray, Forker, Alan, Fredrick, Mark, Fujioka, Ken, Geller, Steven Andrew, Gill, Santosh, Glaser, Linda, Greco, Susan Neims, Greenway, Frank Lyons, Harper, Wayne, Herman, Lee, Hoekstra, John, Ingebretsen, Richard, Ison, Rodney, Jain, Rajeev K, Kaplan, Roy, Kaster, Steven Richard, Haase, Gregory A, Kerzner, Boris, Kirstein, Judith Lee, Koltun, William, Krieger, Diane R, Lewis, Cora Elizabeth, Madder, Robert, Marple, Richard N, McDermott, Edward J, Mello, Curtis John, Miller, Alan B., Mullen, Julie, Nardandrea, John, O'Neil, Patrick, Pi-Sunyer, F. Xavier, Pucillo, Ronald M, Rhee, Chanhaeng, Redrick, Scott, Pardini, Aaron, Rothman, Jeffrey, Rubino, Domenica Marie, Sellers, Gladstone, Smith, Timothy, Byars, William David, Soufer, Joseph, Sussman, Allen Michael, Patrick, Kyle, Schramm, Erich Lloyd, Van Cleeff, Martin, Berg, Saul Reuel, Wyatt, Holly Roxanna, Simon, James Alan, le Roux, Carel W, Astrup, Arne, Greenway, Frank, Lau, David C W, Ortiz, Rafael Violante, Wilding, John P H, Skjøth, Trine V, Manning, Linda Shapiro, and Pi-Sunyer, Xavier

Published
2017
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2. Triple fixed-dose combination empagliflozin, linagliptin, and metformin for patients with type 2 diabetes.

Author

Lingvay, Ildiko, Beetz, Nadine, Sennewald, Regina, Schuler-Metz, Annette, Bertulis, Julia, Loley, Christina, Lang, Benjamin, Lippert, Caroline, Lee, Jisoo, Manning, Linda Shapiro, and Terada, Derek

Subjects
EMPAGLIFLOZIN, TYPE 2 diabetes, METFORMIN, GLYCEMIC control, BLOOD sugar, FREE groups, BENZENE, RESEARCH, COMBINATION drug therapy, RESEARCH methodology, HYPOGLYCEMIC agents, GLYCOSIDES, PHARMACOKINETICS, EVALUATION research, MEDICAL cooperation, COMPARATIVE studies, RANDOMIZED controlled trials, CONTROLLED release preparations, DRUGS, PATIENT compliance, CROSSOVER trials
Abstract

Objectives: Fixed-dose combination (FDC) therapy can improve outcomes in type 2 diabetes (T2D). We evaluated the bioequivalence of 2 doses of an FDC of extended-release metformin (metformin XR), empagliflozin, a sodium-glucose co-transporter 2 inhibitor, and linagliptin, a dipeptidyl peptidase-4 inhibitor, versus corresponding free tablet combinations.Methods: Two randomized, open-label, two-way crossover studies in healthy adults compared: 2 FDC tablets of empagliflozin 5 mg/linagliptin 2.5 mg/metformin XR 1000 mg (Study 1; N = 30), 1 FDC tablet of empagliflozin 25 mg/linagliptin 5 mg/metformin XR 1000 mg (Study 2; N = 30) versus corresponding dose of free combinations. Subjects received study medication under fed conditions; washout was ≥35 days between treatments. Primary endpoints: area under the plasma concentration-time curve (AUC) from time 0 to last quantifiable data point for empagliflozin and metformin; AUC from time 0 to 72 hours for linagliptin, and peak plasma concentration (Cmax) for empagliflozin, linagliptin, and metformin. Bioequivalence was defined as adjusted geometric mean ratios (FDC: free combination) and two-sided 90% confidence intervals (CIs) of AUC and Cmax for each component within 80.00-125.00%.Results: Study 1: 27/29 and 28/30 treated participants were included in the pharmacokinetic analysis for the FDC and free combination periods, respectively. Study 2: 29/29 treated participants were included in the pharmacokinetic analysis for both periods. The adjusted geometric mean ratios of FDCs to their respective free tablet combinations and two-sided 90% CIs were all within the predefined range. The shapes of the mean plasma concentration-time profile of empagliflozin, linagliptin, and metformin XR were similar for subjects in the FDC and free combination groups in both studies. No serious adverse events were reported.Conclusion: The evaluated doses of empagliflozin/linagliptin/metformin XR FDC tablets were bioequivalent to the corresponding free combinations. Based on these two bioequivalence studies and existing phase 3 data, the FDA has recently approved this triple FDC to improve glycemic control in adults with T2D. [ABSTRACT FROM AUTHOR]

Published
2020
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3. Reduction in the risk of developing type 2 diabetes (T2D) with liraglutide 3.0 mg in individuals with prediabetes and obesity or overweight from the SCALE Obesity and prediabetes randomised, double-blind, placebo-controlled trial

Author

O’Moore-Sullivan, Trisha, Roux, Carel W. Le, Astrup, Arne, Fujioka, Ken, Greenway, Frank, Lau, David C.W., van Gaal, Luc, Ortiz, Rafael Violante, Wilding, John P.H., Skjøth, Trine V., Manning, Linda Shapiro, and Pi-Sunyer, Xavier

Published
2019
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6. Reduction in the risk of developing type 2 diabetes (T2D) with liraglutide 3.0 mg in individuals with prediabetes and obesity or overweight from the SCALE Obesity and prediabetes randomised, double-blind, placebo-controlled trial.

Author

O'Moore-Sullivan, Trisha, Roux, Carel W. Le, Astrup, Arne, Fujioka, Ken, Greenway, Frank, Lau, David C.W., van Gaal, Luc, Ortiz, Rafael Violante, Wilding, John P.H., Skjøth, Trine V., Manning, Linda Shapiro, and Pi-Sunyer, Xavier

Subjects
TYPE 2 diabetes diagnosis, TYPE 2 diabetes prevention, TYPE 2 diabetes risk factors, TYPE 2 diabetes treatment, OBESITY treatment, CONFIDENCE intervals, EXERCISE, EXERCISE therapy, PANCREATITIS, PATIENT monitoring, PREDIABETIC state, WEIGHT loss, BODY mass index, RANDOMIZED controlled trials, TREATMENT effectiveness, BLIND experiment, HYPODERMOCLYSIS, KAPLAN-Meier estimator, GLUCAGON-like peptide-1 agonists, ODDS ratio, THERAPEUTICS
Published
2019
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7. 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial.

Author

le Roux, Carel W., Astrup, Arne, Fujioka, Ken, Greenway, Frank, Lau, David C. W., Van Gaal, Luc, Violante Ortiz, Rafael, Wilding, John P. H., Skjøth, Trine V., Shapiro Manning, Linda, Pi-Sunyer, Xavier, Ortiz, Rafael Violante, Manning, Linda Shapiro, and SCALE Obesity Prediabetes NN8022-1839 Study Group

Subjects
*MENTAL illness, *TYPE 2 diabetes, *PLACEBOS, *REGULATION of body weight, *PREDIABETIC state, *RANDOMIZED controlled trials, *TYPE 2 diabetes diagnosis, *HYPOGLYCEMIC agents, *INCRETINS, *OBESITY complications, *SUBCUTANEOUS injections, *BEHAVIOR, *BLOOD sugar, *BODY weight, *COMPARATIVE studies, *RESEARCH methodology, *MEDICAL cooperation, *OBESITY, *RESEARCH, *STATISTICAL sampling, *WEIGHT loss, *GLUCAGON-like peptide 1, *EVALUATION research, *BODY mass index, *TREATMENT effectiveness, *BLIND experiment, *DISEASE complications, *PHARMACODYNAMICS, *DIAGNOSIS, *PREVENTION, *THERAPEUTICS
Abstract

Background: Liraglutide 3·0 mg was shown to reduce bodyweight and improve glucose metabolism after the 56-week period of this trial, one of four trials in the SCALE programme. In the 3-year assessment of the SCALE Obesity and Prediabetes trial we aimed to evaluate the proportion of individuals with prediabetes who were diagnosed with type 2 diabetes.Methods: In this randomised, double-blind, placebo-controlled trial, adults with prediabetes and a body-mass index of at least 30 kg/m2, or at least 27 kg/m2 with comorbidities, were randomised 2:1, using a telephone or web-based system, to once-daily subcutaneous liraglutide 3·0 mg or matched placebo, as an adjunct to a reduced-calorie diet and increased physical activity. Time to diabetes onset by 160 weeks was the primary outcome, evaluated in all randomised treated individuals with at least one post-baseline assessment. The trial was conducted at 191 clinical research sites in 27 countries and is registered with ClinicalTrials.gov, number NCT01272219.Findings: The study ran between June 1, 2011, and March 2, 2015. We randomly assigned 2254 patients to receive liraglutide (n=1505) or placebo (n=749). 1128 (50%) participants completed the study up to week 160, after withdrawal of 714 (47%) participants in the liraglutide group and 412 (55%) participants in the placebo group. By week 160, 26 (2%) of 1472 individuals in the liraglutide group versus 46 (6%) of 738 in the placebo group were diagnosed with diabetes while on treatment. The mean time from randomisation to diagnosis was 99 (SD 47) weeks for the 26 individuals in the liraglutide group versus 87 (47) weeks for the 46 individuals in the placebo group. Taking the different diagnosis frequencies between the treatment groups into account, the time to onset of diabetes over 160 weeks among all randomised individuals was 2·7 times longer with liraglutide than with placebo (95% CI 1·9 to 3·9, p<0·0001), corresponding with a hazard ratio of 0·21 (95% CI 0·13-0·34). Liraglutide induced greater weight loss than placebo at week 160 (-6·1 [SD 7·3] vs -1·9% [6·3]; estimated treatment difference -4·3%, 95% CI -4·9 to -3·7, p<0·0001). Serious adverse events were reported by 227 (15%) of 1501 randomised treated individuals in the liraglutide group versus 96 (13%) of 747 individuals in the placebo group.Interpretation: In this trial, we provide results for 3 years of treatment, with the limitation that withdrawn individuals were not followed up after discontinuation. Liraglutide 3·0 mg might provide health benefits in terms of reduced risk of diabetes in individuals with obesity and prediabetes.Funding: Novo Nordisk, Denmark. [ABSTRACT FROM AUTHOR]

Published
2017
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