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1 Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: in people treated for type 2 diabetes with multiple daily insulin injections: randomised clinical trial (MDI trial) Marcus Lind, MD, PhD, Associate Professor 1,2, Irl B Hirsch, MD, Professor 3, Jaakko Tuomilehto, MD, Professor 4, Sofia Dahlqvist 2, Bo Ahrén, MD, Professor 5, Ole Torffvit, MD, PhD, Associate Professor 5, Stig Attvall, MD, PhD, Associte Professor 1, Magnus Ekelund, MD, PhD 5, Karin Filipsson, MD, PhD 5, Bengt-Olov Tengmark, MD, PhD, Associate Professor 6, Stefan Sjöberg, MD, PhD, Associate Professor 7, Nils-Gunnar Pehrsson, BA 8 1. Institute of Medicine, University of Gothenburg, Gothenburg, Sweden 2. Department of Medicine, NU-Hospital Group, Uddevalla, Sweden 3. University of Washington, Seattle, U.S. 4. Centre for Vascular Prevention, Danube-University, Krems, Austria; Department of Chronic Disease Prevention, National Institute for Health and Welfare, Helsinki, Finland; Diabetes Research Group, King Abdulaziz University, Jeddah, Saudi Arabia 5. Lund University, Lund, Sweden 6. Citydiabetes, Stockholm 7. Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden; Department of Medicine, Halland County Hospital, Halmstad Sweden 8. Statistiska Konsultgruppen, Gothenburg, Sweden 1
2 1 Table of contents 1 Table of contents Procedure for randomisation Changes to eligibility criteria Tables etable 1. Protocol deviations leading to exclusion from Per Protocol population etable 2. Efficacy analyses of the Per Protocol population etable 3. Efficacy analyses of predefined endpoints of all randomised patients
3 2 Procedure for randomisation Treatment kits labelled with sequential code, with the content of each code determined and packed from a traditional block randomisation scheme were used. For label codes, block randomisation was performed with blocks 2+2. The block randomisation scheme for labelling and packaging was created by a statistician, and forwarded to the National Pharmacy, Sweden for packaging/labelling and to one (1) dedicated unblinded data manager for setting up the computerized system that applies the minimization algorithm for label code assignment to subjects. Label codes were assigned to subjects using a central computerized system that applies a minimization algorithm to ensure good statistical balance arms. The system is aware of the treatment arm behind each label code and the available supply at each site, and internally randomises to a treatment arm and then selects, randomly, and reveals a label code matching the treatment arm. Minimization was balancing on the following variables age, sex, weight, HbA1c, and total daily insulin dose, and applies an in- treatment arms difference of max 4 at study level and max 2 at site level. Statistiska Konsultgruppen performed the randomisation scheme. Sites enrolled participants and assigned the intervention, using the above described computerized system. The statistician who created the block randomisation scheme, the National Pharmacy, and one data manager were unblinded. All study personnel and participants were blinded to treatment. The blind was broken by the data manager after clean file and database lock. 3 Changes to eligibility criteria The inclusion/exclusion criteria were changed partly to use more general and conventional cut-offs for variables and partly to facilitate further recruitment. The following changes were made: Lower limit of HbA1c was changed from 8.0% to 7.8% (64 to 62 mmol/l) on 28 January 2013, and from 7.8% to 7.5% (62 to 58 mmol/l) on 2 April Lower limit of C-peptide was changed from 0.2 to 0.15 on 28 January 2013 and from 0.15 to 0.10 nmol/l on 11 July Upper limit of calcitonin was changed from 50 ng/l to 14.6 pmol/l on 28 January Lower limit of fasting glucose was changed from 7.0 to 6.0 mmol/l on 28 January Accepted contraceptive methods were defined from e.g. oral contraceptive pills and intrauterine device (IUD) to accepted methods: oral contraceptive pills, depo provera contraceptive injections, implanted contraceptive, transdermal patch, intrauterine device, vasectomized partner, or abstinence. on 28 January Lower limit of BMI was changed from 28 to 27.5 kg/m 2 on 30 January Upper age limit was changed from 75 to 80 years on 17 June Upper limit of creatinine was changed from 130 to 150 micromol/l on 20 June 2013 Exclusion due to systemic glucocorticoid treatment was changed so that individual treated with systemic corticoid treatment for substitution of cortisol deficiency were able to participate. Changed on 28 August
4 4 Tables 4.1 etable 1. Protocol deviations leading to exclusion from Per Protocol population Variable (n=64) (n=60) Non-PP 6 (9.4%) 5 (8.3%) Reason for exclusion specified Baseline HbA1c sampled long before Baseline visit 2 (33.3%) 2 (40.0%) Early Termination 2 (33.3%) 0 (0.0%) Early Termination + early rescue therapy 0 (0.0%) 1 (20.0%) Early rescue therapy, before 6W 0 (0.0%) 1 (20.0%) Early rescue therapy, W12 and W18 0 (0.0%) 1 (20.0%) Incorrectly included, with too low c-peptide 1 (16.7%) 0 (0.0%) Periods of not taking study medication, including the time before 18W & 24W visits For categorical variables n (%) is presented. 1 (16.7%) 0 (0.0%) 4
5 4.2 etable 2. Efficacy analyses of the Per Protocol population Variable HbA1c (IFCC; mmol/mol), from Baseline to 24 W (10.0) -18 (-46; 11) HbA1c (NGSP; %), from Baseline to 24W (0.92) (-4.21; 1.01) (n=58) (-19.3 to -14.2) (-1.76 to -1.30) (9.88) -3 (-26; 23) (0.904) (-2.379; 2.105) (n=55) p-value (-6.94 to -1.76) (-0.64 to -0.16) Means <.0001 < (-16.0 to - 8.8) <.0001 < (-1.47 to ) Weight (kg), from Baseline to 24W (3.11) (-12.6; 2.1) Fasting Plasma Glucose (mmol/l), from Baseline to 24W (3.39) -1.4 (-14.7; 4.0) HbA1c less than 8.0% (64 mmol/mol) at 24W (-4.55 to -3.04) (-2.41 to -1.16) (2.65) -0.1 (-12.6; 6.1) (2.812) 0.0 (-9.8; 5.2) >= 8.0% (64 mmol/mol) 14 (24.1%) 32 (58.2%) ( to 0.748) ( to 0.156) < 8.0% (64 mmol/mol) 44 (75.9%) 23 (41.8%) HbA1c less than 7.5% (58 mmol/mol) at 24W <.0001 < (-4.85 to ) (-2.20 to ) 5
6 (n=58) >= 7.5% (58 mmol/mol) 23 (39.7%) 42 (76.4%) (n=55) p-value < 7.5% (58 mmol/mol) 35 (60.3%) 13 (23.6%) HbA1c less than 7.0% (53 mmol/mol) at 24W >= 7.0% (53 mmol/mol) 32 (55.2%) 52 (94.5%) < 7.0% (53 mmol/mol) 26 (44.8%) 3 (5.5%) <.0001 Total daily Meal and Basal insulin (Units), from Baseline to 24W (24.0) -12 (-92; 22) CGM Mean (mmol/l), from Baseline to 24W (2.12) (-6.77; 3.84) n=57 CGM SD (mmol/l), from Baseline to 24W (0.718) (-1.767; 1.936) n=57 Number of symptomatic non-severe hypoglycemia < (2.58) 0 (0; 16) (-23.8 to -13.2) (-2.31 to -1.27) ( to ) (18.88) 0 (-89; 27) (2.081) (-3.715; 5.628) n= (0.696) (-1.274; 1.874) n= (3.57) 0 (0; 19) (-8.84 to 2.09) ( to 0.632) ( to 0.211) Means (-22.8 to - 7.5) <.0001 < (-2.63 to ) <.0001 < ( to )
7 Number of asymptomatic non-severe hypoglycemia < (0.539) 0 (0; 4) (n=58) (0.229) 0 (0; 1) (n=55) p-value 0.94 Means Number of symptomatic non-severe hypoglycemia < (0.954) 0 (0; 4) (0.990) 0 (0; 5) 0.57 Number of asymptomatic non-severe hypoglycemia < (0.00) 0.00 (0.00) 1.00 Number of Severe hypoglycemia, Baseline to 24W 0.00 (0.00) 0.00 (0.00) 1.00 Treatment Satisfaction Status Scale Total, from Baseline to 24W Treatment Satisfaction Change Scale Total (range -18 to 18), at 24W 5.16 (7.02) 3 (-7; 28) n= (4.6) 15 (-2; 18) n= (3.19 to 6.31) 1.11 (7.95) 1 (-23; 19) n= (6.84) 11 (-7; 18) n= (-0.05 to 3.11) (1.00 to 5.45)
8 Mean Postprandial glucose level (mmol/l), from Baseline to 24W (2.90) (-13.55; 4.15) n=50 Fasting total cholesterol (mmol/l), from Baseline to 24W (0.541) -0.1 (-1.3; 1.6) n=57 Fasting High-Density Lipoprotein (HDL) cholesterol (mmol/l), from Baseline to 24W Fasting Low-Density Lipoprotein (LDL) cholesterol (mmol/l), from Baseline to 24W (0.137) 0.0 (-0.3; 0.4) n=57 (n=58) (0.497) (-1.1; 1.6) n=56 Fasting Triglycerides (mmol/l), from Baseline to 24W (1.005) (-2.86; 3.40) n= (-3.06 to -1.46) ( to 0.086) (0.003 to 0.075) ( to 0.001) ( to 0.938) (3.229) (-7.000; 6.033) n= (0.718) 0.0 (-2.5; 2.9) n= (0.140) 0.0 (-0.3; 0.4) n= (0.487) -0.1 (-2.1; 1.2) n= (4.030) 0.10 (-2.60; 28.80) n=53 (n=55) p-value ( to 0.604) ( to 0.187) ( to 0.059) ( to 0.033) ( to 1.186) Means (-3.19 to ) ( to 0.134) ( to 0.070) ( to 0.160) 0.72 (0.72;0. 73)* ( to 0.855) 8
9 Systolic Blood Pressure (mmhg), from Baseline to 24W (12.98) -4 (-38; 24) n=56 Diastolic Blood Pressure (mmhg), from Baseline to 24W (10.489) 1 (-20; 26) n=56 For categorical variables n (%) is presented. For continuous variables / / n= is presented. For comparison Fisher s Exact test was used for dichotomous variables and the Fisher s Non Parametric Permutation Test was used for continuous variables. *) Adjustment for variable baseline values is made using Analysis of Covariance (ANCOVA). (n=58) (-7.22 to -0.93) ( to 2.602) 1.91 (13.11) 3.5 (-47; 28) n= (10.741) -0.5 (-27; 43) n=54 (n=55) p-value ( to 4.135) ( to 2.562) Means (-9.53 to ) ( to 3.519) 9
10 4.3 etable 3. Efficacy analyses of predefined endpoints of all randomised patients. Variable HbA1c (IFCC; mmol/mol), from Baseline to 24W (10.48) -18 (-46; 11) HbA1c (NGSP; %), from Baseline to 24W (0.96) (-4.21; 1.01) (n=64) Weight (kg), from Baseline to 24W (3.11) -3.5 (-12.6; 2.1) Fasting Plasma Glucose (mmol/l), from Baseline to 24W (3.39) -1.4 (-14.7; 4.0) ( to ) (-1.74 to ) (-4.43 to ) (-2.37 to ) (n=60) (9.66) -3.5 (-26; 23) (0.88) (-2.38; 2.10) 0.06 (2.72) 0.0 (-12.6; 6.1) (2.96) 0.1 (-9.8; 7.9) (-7.03 to ) (-0.64 to ) (-0.70 to ) (-0.89 to 0.39) p- value Adjuste d Means <.0001 < (-15.6 to - 8.6) <.0001 < (-1.42 to ) <.0001 < (-4.80 to ) (-2.39 to ) 10
11 HbA1c less than 64 mmol/mol (8.0%) at 24W (n=64) (n=60) >= 64 mmol/mol (8.0%) 17 (26.6%) 37 (61.7%) < 64 mmol/mol (8.0%) 47 (73.4%) 23 (38.3%) HbA1c less than 58 mmol/mol (7.5%) at 24W >= 58 mmol/mol (7.5%) 27 (42.2%) 47 (78.3%) < 58 mmol/mol (7.5%) 37 (57.8%) 13 (21.7%) <.0001 HbA1c less than 53 mmol/mol (7.0%) at 24W >= 53 mmol/mol (7.0%) 37 (57.8%) 57 (95.0%) < 53 mmol/mol (7.0%) 27 (42.2%) 3 (5.0%) <.0001 Total daily Meal and Basal insulin (Units), from Baseline to 24W (23.37) -12 (-92; 22) CGM Mean (mmol/l), from Baseline to 24W (2.24) (-7.86; 3.84) n= ( to ) (-2.24 to ) (19.05) 0 (-89; 41) 0.17 (2.03) (-3.71; 5.63) n= (-7.45 to 2.90) (-0.41 to 0.66) p- value Adjuste d Means <.0001 < (-22.7 to - 8.3) <.0001 < (-2.59 to ) 11
12 CGM SD (mmol/l), from Baseline to 24W (0.74) (-1.77; 1.94) n=63 Number of symptomatic non-severe hypoglycaemia < (2.48) 0 (0; 16) (n=64) (-0.62 to ) (n=60) 0.04 (0.67) 0.04 (-1.27; 1.87) n= (3.44) 0 (0; 19) (-0.14 to 0.22) p- value Adjuste d Means (-0.73 to ) 0.96 Number of asymptomatic non-severe hypoglycaemia < 4.0 Number of symptomatic non-severe hypoglycaemia < (0.51) 0 (0; 4) 0.36 (0.91) 0 (0; 4) 0.05 (0.22) 0 (0; 1) 0.25 (0.95) 0 (0; 5) 0.94 (0.94;0. 94)** 0.59 Number of asymptomatic non-severe hypoglycaemia < (0.00) 0.00 (0.00) 1.00 Number of Severe hypoglycaemia, Baseline to 24W 0.00 (0.00) 0.00 (0.00)
13 Treatment Satisfaction Status Scale Total, from Baseline to 24W 4.62 (6.80) 2 (-7; 28) n=63 Treatment Satisfaction Change Scale Total (range -18 to 18), at 24W (4.48) 15.5 (-2; 18) n=58 Mean Postprandial glucose level (mmol/l), from Baseline to 24W (2.85) (-13.55; 4.15) n=53 (n=64) Fasting total cholesterol (mmol/l), from Baseline to 24W (0.54) -0.1 (-1.3; 1.6) Fasting High-Density Lipoprotein (HDL) cholesterol (mmol/l), from Baseline to 24W 0.04 (0.15) 0.0 (-0.3; 0.5) (2.71 to 5.74) (-2.98 to ) (-0.23 to 0.08) (0.01 to 0.08) (n=60) 0.97 (7.96) 1 (-23; 19) n= (6.76) 11 (-7; 18) n= (3.21) (-7.00; 6.03) n= (0.72) 0.0 (-2.5; 2.9) n= (0.14) 0.0 (-0.3; 0.4) n= (-0.18 to 2.95) (-1.00 to 0.62) (-0.11 to 0.21) (-0.01 to 0.06) p- value Adjuste d Means (0.66 to 5.03) (-3.14 to ) (-0.34 to 0.10) ( to 0.065) 13
14 Fasting Low-Density Lipoprotein (LDL) cholesterol (mmol/l), from Baseline to 24W (n=64) (0.50) -0.1 (-1.1; 1.6) n=62 Fasting Triglycerides (mmol/l), from Baseline to 24W 0.05 (0.97) (-2.86; 3.40) Systolic Blood Pressure (mmhg), from Baseline to 24W (13.11) -4 (-38; 24) Diastolic Blood Pressure (mmhg), from Baseline to 24W 0.67 (10.09) 1 (-20; 26) (-0.24 to 0.00) (-0.56 to 0.77) (-7.60 to ) (-1.92 to 2.57) (n=60) (0.52) -0.1 (-2.1; 1.4) n= (3.82) 0.00 (-2.60; 28.80) n= (13.09) 2.5 (-47; 28) 0.22 (10.49) 0 (-27; 43) (-0.19 to 0.07) (-0.29 to 1.10) (-1.85 to 4.14) (-1.73 to 2.90) p- value Adjuste d Means (-0.24 to 0.12) 0.66 (0.66;0. 66)** (-1.26 to 0.67) ( to ) (-3.49 to 2.97) 14
15 (n=64) (n=60) p- value Adjuste d Means For categorical variables n (%) is presented. For continuous variables / / n= is presented. For comparison Fisher s Exact test was used for dichotomous variables and the Fisher s Non Parametric Permutation Test was used for continuous variables. *) Adjustment for variable baseline values is made using Analysis of Covariance (ANCOVA). **) The Fisher Non Parametric Permutation Test failed to approximate the p-value so Monte Carlo simulation (p-value (99% CI)) of Fisher Non Parametric Permutation Test was used instead. 15
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