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  • 1.
    Jendle, Johan
    et al.
    Örebro universitet, Institutionen för medicinska vetenskaper.
    Birkenfeld, A. L.
    Department of Medicine III, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany; Paul Langerhans Institute Dresden, Helmholtz Center Munich at Technische Universität Dresden, Dresden, Germany.
    Polonsky, W. H.
    Behavioral Diabetes Institute, University of California San Diego, San Diego, CA, USA.
    Silver, R.
    Southern New Hampshire Diabetes and Endocrinology, Nashua, NH, USA.
    Uusinarkaus, K.
    DaVita Medical Group, University of Colorado School of Medicine, Colorado Springs, CO, USA.
    Hansen, T.
    Novo Nordisk A/S, Søborg, Denmark.
    Håkan-Bloch, J.
    Novo Nordisk A/S, Søborg, Denmark.
    Tadayon, S.
    Novo Nordisk A/S, Søborg, Denmark.
    Davies, M. J.
    University of Leicester, Diabetes Research Centre, Leicester, UK.
    Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials2019Ingår i: Diabetes, obesity and metabolism, ISSN 1462-8902, E-ISSN 1463-1326, Vol. 21, nr 10, s. 2315-2326Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    AIM: To investigate treatment satisfaction with semaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, versus placebo/active comparators in theSUSTAIN clinical trial programme.

    METHODS: In SUSTAIN 2-5 and 7, the Diabetes Treatment Satisfaction Questionnaire was used to evaluate patient-perceived treatment satisfaction, hyperglycaemia and hypoglycaemia. Post hoc subgroup analyses were conducted to explore the effects of gastrointestinal adverse events (GI AEs), weight loss (>= 5%) or achieving glycaemic (HbA1c < 7%) targets on treatment satisfaction.

    RESULTS: Overall treatment satisfaction increased from baseline to end of treatment with all treatments across trials. Improvements were significantly greater with semaglutide versus comparators/placebo in SUSTAIN 2-5 (all P < 0.05), and generally greater in patients who achieved versus did not achieve weight loss and glycaemic targets, often with greater improvements with semaglutide 1.0 mg versus comparator/placebo in both weight loss groups. In SUSTAIN 7, improvements in overall treatment satisfaction were generally similar between semaglutide and dulaglutide, irrespective of weight loss or glycaemic control. In SUSTAIN 7, changes in overall treatment satisfaction score were generally lower in patients with versus without GI AEs at week 16 (except dulaglutide 0.75 mg), but similar by week 40. Perceived hyperglycaemia was significantly reduced from baseline to end of treatment with semaglutide versus all comparators/placebo (all P < 0.05). No differences between treatments were observed for perceived hypoglycaemia.

    CONCLUSIONS: Semaglutide was associated with significantly greater (SUSTAIN 2-5) or similar (SUSTAIN 7) improvements in overall treatment satisfaction versus comparators/placebo. Improvements in overall treatment satisfaction were generally greater in patients achieving versus not achieving treatment targets. Clinicaltrials.gov: NCT01930188 (SUSTAIN 2), NCT01885208 (SUSTAIN 3), NCT02128932 (SUSTAIN 4), NCT02305381 (SUSTAIN 5) and NCT02648204 (SUSTAIN 7). EudraCT: 2012-004827-19 (SUSTAIN 2), 2012-004826-92 (SUSTAIN 3), 2013-004392-12 (SUSTAIN 4), 2013-004502-26 (SUSTAIN 5) and 2014-005375-91 (SUSTAIN 7).

  • 2.
    Jendle, Johan
    et al.
    Örebro universitet, Hälsoakademin.
    Nauck, M. A.
    Matthews, D. R.
    Frid, A.
    Hermansen, K.
    During, M.
    Zdravkovic, M.
    Strauss, B. J.
    Garber, A. J.
    Weight loss with liraglutide, a once-daily human glucagon-like peptide-1 analogue for type 2 diabetes treatment as monotherapy or added to metformin, is primarily as a result of a reduction in fat tissue2009Ingår i: Diabetes, obesity and metabolism, ISSN 1462-8902, E-ISSN 1463-1326, Vol. 11, nr 12, s. 1163-1172Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Aim The effect on body composition of liraglutide, a once-daily human glucagon-like peptide-1 analogue, as monotherapy or added to metformin was examined in patients with type 2 diabetes (T2D). Methods These were randomized, double-blind, parallel-group trials of 26 [Liraglutide Effect and Action in Diabetes-2 (LEAD-2)] and 52 weeks (LEAD-3). Patients with T2D, aged 18-80 years, body mass index (BMI) < 40 kg/m2 (LEAD-2), < 45 kg/m2 (LEAD-3) and HbA1c 7.0-11.0% were included. Patients were randomized to liraglutide 1.8, 1.2 or 0.6 mg/day, placebo or glimepiride 4 mg/day, all combined with metformin 1.5-2 g/day in LEAD-2 and to liraglutide 1.8, 1.2 or glimepiride 8 mg/day in LEAD-3. LEAD-2/3: total lean body tissue, fat tissue and fat percentage were measured. LEAD-2: adipose tissue area and hepatic steatosis were assessed. Results LEAD-2: fat percentage with liraglutide 1.2 and 1.8 mg/metformin was significantly reduced vs. glimepiride/metformin (p < 0.05) but not vs. placebo. Visceral and subcutaneous adipose tissue areas were reduced from baseline in all liraglutide/metformin arms. Except with liraglutide 0.6 mg/metformin, reductions were significantly different vs. changes seen with glimepiride (p < 0.05) but not with placebo. Liver-to-spleen attenuation ratio increased with liraglutide 1.8 mg/metformin possibly indicating reduced hepatic steatosis. LEAD-3: reductions in fat mass and fat percentage with liraglutide monotherapy were significantly different vs. increases with glimepiride (p < 0.01). Conclusion Liraglutide (monotherapy or added to metformin) significantly reduced fat mass and fat percentage vs. glimepiride in patients with T2D.

  • 3.
    Jendle, Johan
    et al.
    Örebro universitet, Institutionen för medicinska vetenskaper.
    Testa, Marcia A.
    Department of Biostatistics, Harvard T.H. Chan School of Public Health, Harvard University, Boston MA, USA.
    Martin, Sherry
    Eli Lilly and Company, Indianapolis, USA.
    Jiang, Honghua
    Eli Lilly and Company, Indianapolis, USA.
    Milicevic, Zvonko
    Eli Lilly and Company Regional Operations, Vienna, Austria.
    Continuous glucose monitoring in patients with type 2 diabetes treated with glucagon-like peptide-1 receptor agonist dulaglutide in combination with prandial insulin lispro: an AWARD-4 substudy2016Ingår i: Diabetes, obesity and metabolism, ISSN 1462-8902, E-ISSN 1463-1326, Vol. 18, nr 10, s. 999-1005Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Background: Insulin use with GLP-1 receptor agonists is of interest because of the potential for glucose lowering with reduced insulin dosing versus an insulin-only regimen. The AWARD-4 trial, designed to compare these regimens, included a sub-study using 24-hour continuous glucose monitoring (CGM).

    Methods: The AWARD-4 trial randomised 884 conventional insulin regimens-treated patients to dulaglutide 1.5 mg, 0.75 mg and glargine, all in combination with prandial insulin lispro. The CGM sub-study included 144 patients inserted with Medtronic CGMS® iPro™ CGM device to enable 3-day glucose monitoring. CGM sessions were completed at weeks 0, 13, 26, and 52. CGM measures included mean 24-hour glucose, percentage time in target glucose ranges, hyper- and hypoglycaemia, and glucose variability. The primary objective was treatment comparison for percentage time CGM glucose in the 3.9-7.8 mmol/L range after 26 weeks.

    Results: At week 26, mean CGM glucose decreased in all treatment groups (change from baseline -2.8 ± 0.3, -2.4 ± 0.3, and -2.5 ± 0.3 mmol/L for dulaglutide 1.5 mg, 0.75 mg, and glargine, respectively); between-group differences were not statistically significant. Treatment groups were similar for percentage time in 3.9-7.8 mmol/L range. Percentage time in 3.9-10.0 mmol/L range was greater for dulaglutide 1.5 mg than glargine (p < 0.05). Dulaglutide and glargine were associated with decreased glucose variability for all CGM variability indices. Overall within-patient SD was significantly reduced with dulaglutide 1.5 mg versus glargine (p < 0.05). At week 52, there were no significant differences between groups for measures of normoglycaemia or near-normoglycaemia and for the overall within-patient SD. Treatment with glargine was associated with greater increases in percentage time glucose was ≤3.9 mmol/L with statistically significant differences between the groups at 52 weeks (p < 0.05).

    Conclusions: In combination with prandial lispro, treatment with dulaglutide and glargine resulted in similar proportions of glucose values in the normoglycaemic range, but dulaglutide provided an improved balance between the proportion of values within the near-normoglycaemia range and values within the hypoglycaemic range.

  • 4.
    Lindblad, U.
    et al.
    Department of Public Health and Community Medicine/Primary Health Care, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Enheten för allmämedicin, Göteborgs universitet, Göteborg, Sverige; Skaraborg Institute, Skövde, Sweden.
    Lindberg, G.
    Department of Clinical Sciences, Clinical Research Centre, Malmö University Hospital, Lund University, Malmö, Sweden; The NEPI Foundation, Malmö, Sweden.
    Månsson, N.-O.
    Department of Clinical Sciences, Clinical Research Centre, Malmö University Hospital, Lund University, Malmö, Sweden.
    Ranstam, J.
    The NEPI Foundation, Malmö, Sweden; Swedish National Competence Centre for Musculoskeletal Disorders, Department of Orthopædics, Lund University Hospital, Lund, Sweden.
    Tyrberg, M.
    Department of Ophtalmology, Helsingborg Hospital, Helsingborg, Sweden; Department of Clinical Sciences, Lund University, Lund, Sweden.
    Jansson, Stefan
    Family Medicine Research Centre, Örebro University Hospital, Örebro, Sweden.
    Lindwall, K.
    The NEPI Foundation, Malmö, Sweden; The NEPI Foundation, Linköping, Sweden.
    Svärdh, M.
    Department of Clinical Sciences, Clinical Research Centre, Malmö University Hospital, Lund University, Malmö, Sweden; The NEPI Foundation, Malmö, Sweden.
    Kindmalm, L
    Skaraborg Institute, Skövde, Sweden; Skaraborg Primary Care, Skövde, Sweden.
    Melander, A.
    Department of Clinical Sciences, Clinical Research Centre, Malmö University Hospital, Lund University, Malmö, Sweden; The NEPI Foundation, Malmö, Sweden; Community Medicine, Clinical Sciences, Malmö, Sweden.
    Can sulphonylurea addition to lifestyle changes help to delay diabetes development in subjects with impaired fasting glucose? The Nepi ANtidiabetes StudY (NANSY)2011Ingår i: Diabetes, obesity and metabolism, ISSN 1462-8902, E-ISSN 1463-1326, Vol. 13, nr 2, s. 185-8Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    The Nepi ANtidiabetes StudY (NANSY) is a 5-year randomized, double-blind, placebo-controlled trial in Swedish primary care, examining whether the development of type 2 diabetes (T2D) and retinopathy (separately reported) would be delayed in 40- to 70-year-old subjects with impaired fasting glucose (IFG) who, in addition to lifestyle changes, were treated with either placebo or low-dosage sulphonylurea (SU) (1-mg glimepiride; Amaryl). Of 274 subjects (163 men, 111 women), 138 were allocated to placebo (46.0% men, 56.8% women) and 136 to glimepiride (54.0% men, 43.2% women). The primary endpoint was conversion to diabetes. Average follow-up time was 3.71 years; 96 subjects converted to diabetes, 55 allocated to placebo and 41 to glimepiride (absolute difference 9.8%; p = 0.072). In conclusion, the study failed to support the notion that low-dose SU added to lifestyle changes in IFG subjects would help to delay the conversion to diabetes.

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