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1. Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial.

Author

Martens T, Beck RW, Bailey R, Ruedy KJ, Calhoun P, Peters AL, Pop-Busui R, Philis-Tsimikas A, Bao S, Umpierrez G, Davis G, Kruger D, Bhargava A, Young L, McGill JB, Aleppo G, Nguyen QT, Orozco I, Biggs W, Lucas KJ, Polonsky WH, Buse JB, Price D, and Bergenstal RM

Subjects
Aged, Confidence Intervals, Diabetes Mellitus, Type 2 blood, Female, Glycated Hemoglobin analysis, Humans, Male, Middle Aged, Patient Satisfaction, Postprandial Period, Sample Size, Time Factors, Treatment Outcome, Blood Glucose analysis, Diabetes Mellitus, Type 2 drug therapy, Glycemic Control methods, Hypoglycemic Agents therapeutic use, Insulin therapeutic use
Abstract

Importance: Continuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy, but its use in type 2 diabetes treated with basal insulin without prandial insulin has not been well studied., Objective: To determine the effectiveness of CGM in adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices., Design, Setting, and Participants: This randomized clinical trial was conducted at 15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications., Interventions: Random assignment 2:1 to CGM (n = 116) or traditional blood glucose meter (BGM) monitoring (n = 59)., Main Outcomes and Measures: The primary outcome was hemoglobin A1c (HbA1c) level at 8 months. Key secondary outcomes were CGM-measured time in target glucose range of 70 to 180 mg/dL, time with glucose level at greater than 250 mg/dL, and mean glucose level at 8 months., Results: Among 175 randomized participants (mean [SD] age, 57 [9] years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4% [95% CI, -0.8% to -0.1%]; P = .02). In the CGM group, compared with the BGM group, the mean percentage of CGM-measured time in the target glucose range of 70 to 180 mg/dL was 59% vs 43% (adjusted difference, 15% [95% CI, 8% to 23%]; P < .001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, -16% [95% CI, -21% to -11%]; P < .001), and the means of the mean glucose values were 179 mg/dL vs 206 mg/dL (adjusted difference, -26 mg/dL [95% CI, -41 to -12]; P < .001). Severe hypoglycemic events occurred in 1 participant (1%) in the CGM group and in 1 (2%) in the BGM group., Conclusions and Relevance: Among adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin, continuous glucose monitoring, as compared with blood glucose meter monitoring, resulted in significantly lower HbA1c levels at 8 months., Trial Registration: ClinicalTrials.gov Identifier: NCT03566693.

Published
2021
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2. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes

Author

Gough, S. C., Bode, B., Woo, V., Rodbard, H. W., Linjawi, S., Poulsen, P., Damgaard, L. H., Buse, J. B., NN9068 3697 trial investigators, Donnelly, T, Gerstman, M, Linjawi, S, Park, K, Roberts, A, Shaw, Je, Wu, T, Aggarwal, N, Bowering, K, Chouinard, G, Deyoung, P, Dumas, R, Elliott, Tg, Frechette, A, Giguere, N, Gottesman, I, Ho, K, Kohli, S, Teitelbaum, I, Tytus, R, Wharton, S, Woo, V, Hellsten, T, Kuusela, M, Sarti, C, Strand, J, Valli, K, Erlinger, R, Goelz, S, Hauser, Kh, Hilgenberg, J, Kaiser, M, Marck, C, Merfort, F, Milek, K, Paschen, B, Rose, L, Schlecht, K, Wenzl Bauer, V, Dudas, M, Fulop, G, Harcsa, E, Kerenyi, Z, Szőcs, A, Takacs, R, Babu, T, Bandgar, Tr, Bantwal, G, Bhagwat, Nm, Chatterjee, S, Jain, Sm, John, M, Kale, S, Kanungo, Ak, Kumar, A, Kumar, H, Kumar, Sn, Lodha, S, Majumder, A, Mithal, A, Murthy, S, Sethi, Bk, Shah, P, Sharma, Sk, Sivagnanam, N, Velu, S, Viswanathan, V, Yajnik, Cs, Byrne, M, O'Brien, T, Aimaretti, G, Baroni, Mg, D'Amico, E, Dotta, Francesco, Giordano, C, Sforza, A, Tonolo, G, Bebakar, Wm, Kamaruddin, Na, Hussein, Z, Mumtaz, M, Sothiratnam, R, Gonzalez Galvez, G, Hernandez, Pa, Grineva, E, Kalashnikova, Mf, Kulkova, P, Krasilnikova, Ee, Kondrachenko, S, Kunitsyna, Ma, Poley, M, Sardinov, R, Vorokhobina, Nv, Yurievna, M, Zhdanova, Ea, Zhukova, La, Dalan, R, Khoo, Ey, Sum, Cf, Cizova, M, Martinka, E, Schroner, Z, Teplanova, M, Tomasova, L, Biermann, E, Dulabh, R, Khutsoane, Dt, Komati, Sm, Makan, Ha, Mayet, L, Mitha, Ea, Padayachee, T, Pillay, S, Reddy, J, Snyman, Hh, Siddique, N, Trokis, J, Bobillo, Er, de la Cuesta, C, Fernández, Mr, González, As, De Teresa Parreño, L, Raya, Pm, de la Torre ML, Torres, Jf, Sheu, Wh, Sun, Jh, Yang, Cy, Deerochanawong, C, Phornphutkul, M, Suwanwalaikorn, S, Sriwijitkamol, A, Clark, J, Downie, P, Evans, P, Furlong, N, Gough, S, Harper, R, Harvey, Jn, Khan, A, Leese, G, Mckinnon, C, Narendran, P, Patterson, C, Raymond, F, Singhal, P, Smith, P, Viljoen, A, Willis, T, Acampora, M, Agaiby, Jm, Ahmed, I, Allison, Jr, Altamirano, D, Anderson, Mw, Andrawis, N, Aroda, Vr, Ballard, Tv, Beavins, J, Bedel, Gw, Bernstein, R, Blaze, K, Bode, Bw, Bononi, Pl, Broker, Re, Buse, Jb, Butuk, Dj, Camiscoli, Dj, Canadas, R, Castorino, K, Cathcart, H, Cha, G, Chang, A, Chappel, Cm, Cheema, C, Chenore, M, Cheung, D, Christensen, J, Chu, Jw, Chuck, L, Cohen, Cd, Cohen, K, Cho, Mh, Rivera Colon, L, Condit, J, Corbett, B, Pearlstein, R, Cox, Wr, Daboul, Ny, Deatkine, D, Dunn, Lj, Ellison, Hs, Feldman, Bn, Fidelholtz, J, First, B, Fishman, N, Fogarty, Cm, Fraser, Nj, Gabra, N, Gaona, Re, Gerety, G, Gilman, Rm, Gonte, Ws, Gottschlich, Gm, Grant, Dm, Hewitt, M, Hollander, P, House, Ba, Huffman, D, Jain, Rk, Johnson, G, Jones, Sw, Kayne, Dm, Kimmel, Ma, Klonoff, D, Knight, H, Koontz, D, Kutner, Me, Lenhard, Jm, Liss, Jl, Litchfield, Wr, Lubin, B, Lucas, Kj, Lynn, L, Lyons, Tj, Macadams, Mr, Mach, Mq, Maletz, L, Mariano, Hg, Mayeda, So, Pratley, Re, Madder, R, Martinez, Gj, Mcgarity WC Jr, Mckenzie, Wc, Meisner, Cr, Montenegro, C, Moran, Je, Morawski, Ej, Moretto, Tj, Mudaliar, Sr, Murray, Av, Myers, L, Odugbesan, Ao, Olivarez, E, Pangtay, D, Patel, Mb, Patel, Nr, Patel, R, Perdomo, A, Pritchett, Kl, Rasmussen, B, Reed, Jc, Reeves, Ml, Reichman, A, Rhee, C, Rice, Lc, Risser, J, Rodbard, Hw, Rosen, R, Rosenstock, J, Ryan, Eh, Schreiman, Rc, Scott, Rb, Selagamsetty, Mr, Shaughnessy, J, Silver, R, Simon, Hj, Snyder, B, Soufer, J, Stegemoller, Rk, Sugimoto, D, Thurman, J, Tolia, Kk, Wagner, R, Wahlen, J, Webster, De, Weisbrot, Aj, Whittier, F, Winkle, Pj, Woolley, Jh, Yeoman, G, Zemel, Lr, Smith, Bp, Philis Tsimikas, A, Weissman, P, and Kurland Wise, J.

Subjects
Insulin degludec, Blood Glucose, Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Urology, Type 2 diabetes, law.invention, Endocrinology, Randomized controlled trial, law, Glucagon-Like Peptide 1, Internal medicine, Diabetes mellitus, Internal Medicine, medicine, Humans, Hypoglycemic Agents, Glycated Hemoglobin, Liraglutide, business.industry, Insulin, Middle Aged, medicine.disease, Metformin, Insulin, Long-Acting, Drug Combinations, Treatment Outcome, Diabetes Mellitus, Type 2, Female, business, Pioglitazone, medicine.drug
Abstract

A fixed-ratio combination of the basal insulin analogue insulin degludec and the glucagon-like peptide-1 (GLP-1) analogue liraglutide has been developed as a once-daily injection for the treatment of type 2 diabetes. We aimed to compare combined insulin degludec-liraglutide (IDegLira) with its components given alone in insulin-naive patients.In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day). IDegLira and insulin degludec were titrated to achieve a self-measured prebreakfast plasma glucose concentration of 4-5 mmol/L. The primary endpoint was change in HbA1c after 26 weeks of treatment, and the main objective was to assess the non-inferiority of IDegLira to insulin degludec (with an upper 95% CI margin of 0·3%), and the superiority of IDegLira to liraglutide (with a lower 95% CI margin of 0%). This study is registered with ClinicalTrials.gov, number NCT01336023.1663 adults (mean age 55 years [SD 10], HbA1c 8·3% [0·9], and BMI 31·2 kg/m(2) [4·8]) were randomly assigned, 834 to IDegLira, 414 to insulin degludec, and 415 to liraglutide. After 26 weeks, mean HbA1c had decreased by 1·9% (SD 1·1) to 6·4% (1·0) with IDegLira, by 1·4% (1·0) to 6·9% (1·1) with insulin degludec, and by 1·3% (1·1) to 7·0% (1·2) with liraglutide. IDegLira was non-inferior to insulin degludec (estimated treatment difference -0·47%, 95% CI -0·58 to -0·36, p0·0001) and superior to liraglutide (-0·64%, -0·75 to -0·53, p0·0001). IDegLira was generally well tolerated; fewer participants in the IDegLira group than in the liraglutide group reported gastrointestinal adverse events (nausea 8·8 vs 19·7%), although the insulin degludec group had the fewest participants with gastrointestinal adverse events (nausea 3·6%). We noted no clinically relevant differences between treatments with respect to standard safety assessments, and the safety profile of IDegLira reflected those of its component parts. The number of confirmed hypoglycaemic events per patient year was 1·8 for IDegLira, 0·2 for liraglutide, and 2·6 for insulin degludec. Serious adverse events occurred in 19 (2%) of 825 patients in the IDegLira group, eight (2%) of 412 in the insulin degludec group, and 14 (3%) of 412 in the liraglutide group.IDegLira combines the clinical advantages of basal insulin and GLP-1 receptor agonist treatment, resulting in improved glycaemic control compared with its components given alone.Novo Nordisk.

Published
2014

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