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Emerging Therapies: Drugs and Regimens

Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial

  1. W. Timothy Garvey1⇑,
  2. Andreas L. Birkenfeld2,3,4,
  3. Dror Dicker5,6,
  4. Geltrude Mingrone4,7,8,
  5. Sue D. Pedersen9,
  6. Altynai Satylganova10,
  7. Dorthe Skovgaard10,
  8. Danny Sugimoto11,
  9. Camilla Jensen10 and
  10. Ofri Mosenzon12
  1. 1Department of Nutrition Sciences, The University of Alabama at Birmingham and the Birmingham VA Medical Center, Birmingham, AL
  2. 2Department of Diabetology, Endocrinology, and Nephrology, Eberhard Karls University Tübingen, Tübingen, Germany
  3. 3Institute for Diabetes Research and Metabolic Diseases, Helmholtz Centre Munich at the University of Tübingen, Tübingen, Germany
  4. 4Division of Diabetes and Nutritional Sciences, Faculty of Life Sciences and Medicine, King’s College London, London, U.K.
  5. 5Internal Medicine D, Hasharon Hospital, Rabin Medical Center, Petah Tikva, Israel
  6. 6Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
  7. 7Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
  8. 8Università Cattolica del Sacro Cuore, Rome, Italy
  9. 9C-ENDO Diabetes and Endocrinology Clinic, Calgary, Alberta, Canada
  10. 10Novo Nordisk A/S, Søborg, Denmark
  11. 11Cedar Crosse Research Center, Chicago, IL
  12. 12Diabetes Unit, Department of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel
  1. Corresponding author: W. Timothy Garvey, garveyt{at}uab.edu
Diabetes Care 2020 May; 43(5): 1085-1093. https://doi.org/10.2337/dc19-1745
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    Figure 1

    Change in body weight and glycemic control over time. A: Change in body weight (percentage); observed mean data ± SEM. n values refer to all individuals who attended visit regardless of treatment status; on-drug n values refer to individuals who were still on active treatment at time of visit. B: Change in HbA1c; observed mean data ± SEM. n values refer to all individuals who attended visit regardless of treatment status; on-drug n values refer to individuals who were still on active treatment at time of visit. C: Change in total daily insulin dose; graph shows observed mean data ± SEM. n values refer to all individuals who attended visit regardless of treatment status; on-drug n values refer to individuals who were still on active treatment at time of visit. U, units.

Tables

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  • Table 1

    Baseline demographics and medications

    Liraglutide 3.0 mg (n = 198)Placebo (n = 198)
    Male sex, n (%)90 (45.5)99 (50.0)
    Mean age, years (SD)55.9 (11.3)57.6 (10.4)
    Race, n (%)
     White174 (87.9)180 (90.9)
     Black17 (8.6)11 (5.6)
     Asian3 (1.5)5 (2.5)
    Ethnicity not Hispanic or Latino, n (%)155 (78.3)169 (85.4)
    Mean body weight, kg (SD)*100.6 (20.8)98.9 (19.9)
    Mean BMI, kg/m2 (SD)35.9 (6.5)35.3 (5.8)
    Mean waist circumference, cm (SD)114.8 (13.7)114.2 (13.2)
    Mean HbA1c, % (SD)7.9 (1.1)8 (1.0)
    Mean HbA1c, mmol/mol (SD)63.0 (11.5)63.6 (11.3)
    Mean FPG, mmol/L (SD)7.8 (2.2)8.1 (2.5)
    Mean FPG, mg/dL (SD)141 (40)146 (46)
    Mean diabetes duration, years (SD)11.4 (6.8)12.8 (6.9)
    Mean heart rate, bpm (SD)†74.0 (10.0)75.0 (11.0)
    Mean SBP, mmHg (SD)129.0 (14.0)132.0 (16.0)
    Mean DBP, mmHg (SD)78.0 (9.0)78.0 (9.0)
    Mean total cholesterol, mmol/L (SD)4.5 (1.0)4.4 (0.9)
    Mean total cholesterol, mg/dL (SD)172 (39)171 (36)
    Mean LDL cholesterol, mmol/L (SD)2.4 (0.9)2.4 (0.8)
    Mean LDL cholesterol, mg/dL (SD)94 (33)94 (29)
    Mean HDL cholesterol, mmol/L (SD)1.2 (0.3)1.2 (0.3)
    Mean HDL cholesterol, mg/dL (SD)45 (12)45 (11)
    Mean VLDL cholesterol, mmol/L (SD)0.9 (0.4)0.8 (0.4)
    Mean VLDL cholesterol, mg/dL (SD)33 (16)32 (15)
    Mean triglycerides, mmol/L (SD)2.0 (1.2)1.9 (1.0)
    Mean triglycerides, mg/dL (SD)174 (105)168 (89)
    Mean free fatty acids, mmol/L (SD)0.6 (0.2)0.6 (0.3)
    Mean free fatty acids, mg/dL (SD)15.9 (6.9)15.5 (7.3)
    Antidiabetic medications at screening, n (%)
     Biguanides175 (88.4)176 (88.9)
     SUs68 (34.3)71 (35.9)
     SGLT2i44 (22.2)44 (22.2)
     Thiazolidinediones4 (2.0)6 (3.0)
     Combination BG-lowering drugs (oral)4 (2.0)3 (1.5)
     α-Glucosidase inhibitors2 (1.0)0 (0.0)
     Other BG-lowering drugs, excluding insulins1 (0.5)5 (2.5)
    Insulins/analogs (injection), n (%)
     Long-acting180 (90.9)184 (92.9)
     Intermediate-acting18 (9.1)14 (7.1)
    • DBP, diastolic blood pressure; SBP, systolic blood pressure; SGLT2i, sodium–glucose cotransporter 2 inhibitor.

    • ↵* Body weight measurements include both fasting and nonfasting measures.

    • ↵† Safety analysis set; liraglutide, n = 195; placebo, n = 197.

  • Table 2

    Change in primary and secondary end points from baseline to week 56: treatment policy estimand

    Liraglutide 3.0 mg (n = 198)Placebo (n = 198)ETD/OR* (95% CI)P value
    Primary end points
     Change in body weight from baseline, %−5.8−1.5−4.3 (−5.5; −3.2)<0.0001
     Proportion of individuals achieving ≥5% weight loss,* %51.824.03.4 (2.2; 5.3)<0.0001
    Secondary confirmatory end points
     Proportion of individuals achieving >10% weight loss,* %22.86.64.2 (2.2; 8.2)<0.0001
     Change in waist circumference from baseline, cm−5.3−2.6−2.7 (−3.9; −1.5)<0.0001
     Change in HbA1c from baseline, %−1.1−0.6−0.5 (−0.8; −0.3)<0.0001
     Change in HbA1c from baseline, mmol/mol−11.9−6.0−5.8 (−8.3; −3.4)<0.0001
     Change in FPG from baseline, mmol/L−1.0−0.6−0.4 (−0.9; 0.1)0.1502
     Change in FPG from baseline, mg/dL−18.4−11.5−6.9 ( −16.4; 2.5)0.1502
     Change in SF-36 physical functioning score from baseline2.72.30.4 (−1.0; 1.8)0.5716
     Change in IWQOL-Lite for CT physical function domain score from baseline8.25.72.5 (−1.5; 6.4)0.2218
    Secondary supportive end points
     Change in total daily insulin dose from baseline, units2.817.8−15.0 (−22.0; −8.0)<0.0001
     Change in mean daytime glucose value from baseline, mmol/L−2.2−1.5−0.7 (−1.1; −0.2)0.0032
     Change in mean daytime glucose value from baseline, mg/dL−39.6−27.3−12.4 (−20.6; −4.1)0.0032
     Individuals achieving ≥5% weight loss and HbA1c <7% at week 56*39.013.93.9 (2.4; 6.5)<0.0001
     Individuals achieving ≥5% weight loss, HbA1c <7%, and no documented symptomatic hypoglycemia at week 56*17.86.23.3 (1.66; 6.48)0.0006
     Change in systolic blood pressure from baseline, mmHg−5.6−1.6−4.0 (−6.4; −1.5)0.0014
     Change in diastolic blood pressure from baseline, mmHg−2.3−0.9−1.4 (−3.0; 0.2)0.0905
     Total cholesterol†0.971.010.97 (0.94; 1.00)0.0463
     LDL cholesterol†0.971.010.96 (0.91; 1.01)0.1027
     HDL cholesterol†1.041.021.02 (0.99; 1.04)0.2778
     VLDL cholesterol†0.890.940.94 (0.88; 1.01)0.0830
     Triglycerides†0.880.940.94 (0.87; 1.01)0.0715
     Free fatty acids†0.790.840.95 (0.85; 1.07)0.3936
    • Baseline to week 56 vs. placebo. Full analysis set. Statistical analysis is ANCOVA with jump-to-reference multiple imputation.

    • ↵* The end point is analyzed in a logistic regression model.

    • ↵† Data are treatment ratios (liraglutide 3.0 mg/placebo).

  • Table 3

    Safety data (on-drug)

    Liraglutide 3.0 mgPlacebo
    n (%)ERn (%)ER
    Number of individuals195——197——
    Total AEs180 (92.3)1,139578.3175 (88.8)1,053531.2
    Serious AEs16 (8.2)2311.719 (9.6)2512.6
    Fatal AEs0 (0.0)00.00 (0.0)00.0
    Events leading to treatment discontinuation15 (7.7)178.66 (3.0)63.0
    GI AEs121 (62.1)408207.192 (46.7)202101.9
     Nausea58 (29.7)10553.323 (11.7)2713.6
     Constipation28 (14.4)3618.317 (8.6)2110.6
     Diarrhea45 (23.1)7739.130 (15.2)5427.2
     Vomiting32 (16.4)5326.912 (6.1)136.6
     Abdominal discomfort11 (5.6)178.68 (4.1)115.5
    Hypoglycemic episodes140 (71.8)1,462742.3140 (71.1)1,859937.9
    ADA classified
     Severe3 (1.5)31.52 (1.0)21.0
     Asymptomatic116 (59.5)742376.7116 (58.9)988498.4
     Documented symptomatic92 (47.2)662336.1102 (51.8)816411.7
     Pseudohypoglycemia17 (8.7)4221.314 (7.1)3115.6
     Probable symptomatic8 (4.1)105.118 (9.1)2211.1
     Unclassifiable2 (1.0)31.50 (0.0)00
    • Safety analysis set. Hypoglycemic episodes were classified using ADA criteria and recorded in individual diaries. Data are from individuals on-drug.

    • E, number of events; GI, gastrointestinal; n, number of individuals experiencing at least one event; %, percentage of individuals experiencing at least one event; R, event rate per 100 patient-years of exposure.

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Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial
W. Timothy Garvey, Andreas L. Birkenfeld, Dror Dicker, Geltrude Mingrone, Sue D. Pedersen, Altynai Satylganova, Dorthe Skovgaard, Danny Sugimoto, Camilla Jensen, Ofri Mosenzon
Diabetes Care May 2020, 43 (5) 1085-1093; DOI: 10.2337/dc19-1745

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Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial
W. Timothy Garvey, Andreas L. Birkenfeld, Dror Dicker, Geltrude Mingrone, Sue D. Pedersen, Altynai Satylganova, Dorthe Skovgaard, Danny Sugimoto, Camilla Jensen, Ofri Mosenzon
Diabetes Care May 2020, 43 (5) 1085-1093; DOI: 10.2337/dc19-1745
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