Ardhanareeshwarn, Sharada Shah, Parag Kumar, Ajay. Romania: Popa, Amorin Ciomos, Daniela Mistodie, Cristina
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1 Participating Investigators: Argentina: Massari, Fabio Sposetti, Georgina Maffei, Laura Starosiliz, David Goycoa, Claudia Perez Mangui, Federico Chertkoff, Alejandro Salzberg, Susana Belgium: Mathieu, Chantal Timmermans, Bruno Quintens, Theo Reynders, Paul Brazil: Canani, Luis Henrique Forti, Adriana Chacra, Antonio Geloneze, Bruno Baggentoss, Rejane Bandeira, Francisco Eliaschewitz, Freddy Borges, Joao Hissa, Miguel Rea, Rosangela Canada: Duffy, Patrick Rosenthall, Wendy Shu, Daniel Garon, Jean Kooy, Jacobus Janzen, Jeannette Gavin, Claire France: Boye, Alain Boucher, Loic Guinet, Jean Michel Lejay, Dominique Germany: Hanefeld, Markolf Rose, Ludger Forst, Thomas Naudts, Ingomar Hungary: Fulop, Gabor Kis-gombos, Piroska Dudas, Mihaly India: Kumar, Harish Tandon, Nikhil Balaji, Vijayan Yajnik, Chittaranjan Vishwanathan, Vijay Shivane, Vyankatesh Prasanna Kumar, Kankatte Chatterjee, Sudip Ardhanareeshwarn, Sharada Shah, Parag Kumar, Ajay Israel: Wainstein, Julio Karasik, Avraham Minuchin, Oscar Italy: Dotta, Francesco Bonomo, Matteo Korea: Yoon, Kun-ho Park, Sung Woo Lee, In Kyu Baik, Sei Hyun Choi, Dong Seop Kim, In Joo Koo, Bo Kyung Moon, Min Kyong Kang, Eun Seok Lee, Hyun Chul Park, Tae Sun Park, Seok-won Mexico: Nevarez, Luis Mauricio, Gilberto Gonzalez, Gerardo Poland: Nowakowski, Andrzej Jarosz-skokowska, Ewa Stasinska, Teresa Gromniak, Elwira Romania: Popa, Amorin Ciomos, Daniela Mistodie, Cristina Russia: Vorobiev, Sergey Arefieva, Elena Pronin, Vyatcheslav Miroshnichenko, Olga Ivanova, Svetlana Dvoryashina, Irina Zhavoronkova, Natalia Slavitskaya, Elena Alpenidze, Diana Slovakia: Ilavska, Adriana Duda, Jozef South Africa: Coetzer, Thomas Wing, Jeffrey Bhana, Sindeep Jacovides, Andrew Spain: Duran Garcia, Santiago Vazquez Martinez, Clotilde Gonzalbez Morgaez, Jose De Teresa, Luis Taiwan: Ma, Wen-ya Huang, Chien-ning Wang, Tzu-yuan Hsieh, An-tsz Turkey: Altuntas, Yuksel United Kingdom: Stephens, Jeffrey Russell-Jones, David Atkin, Stephen Barnett, Anthony Cahill, Thomas Frier, Brian United States: Adelizzi, Angela Miller, Jeffrey Blevins, Thomas Greco, Susan Brown, Morris Butuk, David Comulada Rivera, Angel Cuddihy, Robert Guice, Michael Harris, Ronald Herring, Charles Jacks, Randal Kennedy, John Severa, Larry Ortiz-Carrasquillo, Ramon Pin, Michael Rovner, Sergio Samson, Mercedes Bhargava, Anuj 1
2 Supplementary Table 1. Demographics and baseline characteristics EQW (N=248) MET (N=246) PIO (N=163) SITA (N=163) Age, y 54 (11) 54 (11) 55 (11) 52 (11) Gender, n % Male 139 (56.0) 154 (62.6) 97 (59.5) 94 (57.7) Female 109 (44.0) 92 (37.4) 66 (40.5) 69 (42.3) Race/Ethnicity, n % Caucasian 169 (68.1) 160 (65.0) 110 (67.5) 113 (69.3) East Asian 34 (13.7) 31 (12.6) 19 (11.7) 18 (11.0) West Asian 21 (8.5) 20 (8.1) 15 (9.2) 15 (9.2) Hispanic 16 (6.5) 21 (8.5) 15 (9.2) 13 (8.0) African 7 (2.8) 11 (4.5) 4 (2.5) 3 (1.8) Other a 1 (0.4) 3 (1.2) 0 (0) 1 (0.6) Weight, kg 87.5 (18.9) 85.9 (19.6) 86.1 (17.8) 88.7 (18.7) BMI, kg/m (5.3) 30.7 (5.5) 31.1 (5.3) 31.8 (5.4) HbA 1c, % 8.5 (1.2) 8.6 (1.2) 8.5 (1.2) 8.5 (1.3) FSG, mmol/l 9.9 (2.9) 10.0 (3.4) 9.8 (3.0) 9.7 (2.6) Duration of T2D, y 2.7 (3.2) 2.6 (3.6) 2.7 (3.7) 2.7 (3.7) Data are presented as n (%) or mean (SD). a Native American, Aboriginal and/or Torres Strait Islander. ITT population. Abbreviations: HbA 1c = hemoglobin HbA 1c ; BMI = body mass index; EQW = exenatide once weekly; FSG = fasting serum glucose; MET = metformin; PIO = pioglitazone; SITA = sitagliptin; T2D = type 2 diabetes.
3 Supplementary Table 2. Resolution of ongoing treatment-emergent adverse events during the 10-week safety follow-up EQW (N=248) MET (N=246) PIO (N=163) SITA (N=163) Ongoing a Resolved b Ongoing a Resolved b Ongoing a Resolved b Ongoing a Resolved b Headache 2 (0.8) 1 (0.4) 1 (0.4) 0 (0) 0 (0) 0 (0) 1 (0.6) 1 (0.6) Diarrhoea 2 (0.8) 1 (0.4) 10 (4.1) 1 (0.4) 0 (0) 0 (0) 1 (0.6) 0 (0) Injection Site 18 (7.3) 8 (3.2) 17 (6.9) 8 (3.3) 3 (1.8) 1 (0.6) 9 (5.5) 2 (1.2) Nodule Nasopharyngitis 1 (0.4) 1 (0.4) 2 (0.8) 0 (0) 0 (0) 0 (0) 1 (0.6) 0 (0) Nausea 1 (0.4) 0 (0) 3 (1.2) 1 (0.4) 0 (0) 0 (0) 0 (0) 0 (0) Dyspepsia 5 (2.0) 0 (0) 2 (0.8) 1 (0.4) 1 (0.6) 0 (0) 1 (0.6) 0 (0) Constipation 1 (0.4) 0 (0) 1 (0.4) 0 (0) 0 (0) 0 (0) 2 (1.2) 0 (0) Back Pain 0 (0) 0 (0) 5 (2.0) 1 (0.4) 2 (1.2) 0 (0) 1 (0.6) 0 (0) Arthralgia 7 (2.8) 0 (0) 3 (1.2) 0 (0) 5 (3.1) 1 (0.6) 2 (1.2) 1 (0.6) Hypertension 2 (0.8) 0 (0) 3 (1.2) 0 (0) 8 (4.9) 0 (0) 3 (1.8) 0 (0) Peripheral oedema 0 (0) 0 (0) 1 (0.4) 0 (0) 2 (1.2) 0 (0) 0 (0) 0 (0) Data are presented as n (%) of patients. a At 26 weeks; b By the end of the 10-week safety follow-up. ITT population. Abbreviations: EQW = exenatide once weekly; MET = metformin; PIO = pioglitazone; SITA = sitagliptin.
4 Supplementary Table 3. Change in HbA 1c (%) from baseline by anti-exenatide antibody status at endpoint Antibody to exenatide at endpoint (LOCF) Endpoint HbA 1c (LOCF) Change from Baseline to Endpoint (LOCF) Between-group treatment comparison LS mean difference (pvalue) 2-level status Negative (n=96) 7.12 (0.12) (0.12) N/A Positive (n=135) 7.03 (0.10) (0.10) 0.08 (p=0.549) 3-level status Negative (n= (0.12) (0.12) N/A Positive lower (n=107) 6.92 (0.12) (0.12) 0.18 (p=0.214) Positive higher (n=28) 7.40 (0.20) (0.20) (p=0.179) Abbreviations: LOCF = last post-baseline measurement carried forward; LS mean = least-squares mean; n = number of patients having both baseline and post-baseline data; n = total number of patients; N/A = not applicable; SE = standard error. Note: Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Antibodies to exenatide were defined as a positive titer reported after a negative titer at baseline, or a positive titer that had increased by at least three dilutions from a detectable baseline titer. Analysis of covariance (ANCOVA) model: Post-baseline Response Variable = Antibody to Exenatide at Endpoint + Baseline Response Variable + Pooled Country (Type III sums of squares).
5 Supplementary Table 4. IWQOL-Lite Total Scores Endpoint (LOCF) Change from Baseline to Endpoint (LOCF) Comparison EQW vs. Comparators LS mean difference (95% CI) Between-group Comparison p-value EQW (n=228) (0.77) 4.85 (0.77) N/A N/A MET (n=221) (0.77) 4.84 (0.77) 0.01 (-2.02, 2.04) PIO (n=142) (0.94) 1.31 (0.94) 3.54 (1.23, 5.84) SITA (n=142) (0.95) 4.02 (0.95) 0.83 (-1.48, 3.13) Abbreviations: CI = confidence interval; EQW = exenatide once weekly; IWQOL-Lite = Impact of Weight on Quality of Life Questionnaire-Lite; LOCF = last post-baseline measurement carried forward; LS Mean = least-squares mean; MET = metformin; n = number of patients having both baseline and post-baseline data; N/A = not applicable; PIO = pioglitazone; SE = standard error; SITA = sitagliptin; vs. = versus. Note: Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included. Analysis of covariance (ANCOVA) model: Post-baseline Variable = + Baseline Response Variable + Pooled Country (Type III sums of squares). The two-sided 95% confidence interval is for the LS mean difference between Exenatide, MET, PIO and SITA.
6 Supplementary Table 5. BES Total Score Endpoint (LOCF) Change from Baseline to Endpoint (LOCF) Comparison EQW vs. Comparators LS mean difference (95% CI) Between-group Comparison p-value EQW (n=212) 5.02 (0.34) (0.34) N/A N/A MET (n=196) 5.04 (0.35) (0.35) (-0.94, 0.89) PIO (n=163) 6.61 (0.41) (0.41) (-2.61, -0.57) SITA (n=163) 5.99 (0.41) (0.41) (-1.98, 0.03) Abbreviations: BES = Binge Eating Scale; CI = confidence interval; EQW = exenatide once weekly; LOCF = last post-baseline measurement carried forward; LS mean = least-squares mean; MET = metformin; n = number of patients having both baseline and post-baseline data; N/A = not applicable; PIO = pioglitazone; SE = standard error; SITA = sitagliptin; vs. = versus. Note: Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included. Analysis of covariance (ANCOVA) model: Post-baseline Response Variable = + Baseline Response Variable + Pooled Country (Type III sums of squares). The two-sided 95% confidence interval is for the LS mean difference between Exenatide, MET, PIO and SITA.
7 Supplementary Table 6. DTSQc Total Scores Endpoint (LOCF) Comparison EQW vs. Comparators LS mean difference (95% CI) Between-group Comparison p-value EQW (n=221) N/A N/A MET (n=224) (-0.48, 1.78) PIO (n=143) (-1.55, 1.01) SITA (n=140) (-0.70, 1.87) Abbreviations: CI = confidence interval; DTSQc = Diabetes Satisfaction Questionnaire (change version); EQW = exenatide once weekly; LOCF = last post-baseline measurement carried forward; LS mean = least-squares mean; MET = metformin; n = number of patients having both baseline and post-baseline data; N/A = not applicable; PIO = pioglitazone; SE = standard error; SITA = sitagliptin; vs. = versus. Analysis of covariance (ANCOVA) model: Post-baseline Response Variable = + Pooled Country (Type III sums of squares). The two-sided 95% confidence interval is for the LS mean difference between Exenatide, MET, PIO and SITA.
8 Supplementary Table 7. DTSQs Total Scores Endpoint (LOCF) Change from Baseline to Endpoint (LOCF) Comparison EQW vs. Comparators LS mean difference (95% CI) Between-group Comparison p-value EQW (n=222) (0.40) 3.38 (0.40) N/A N/A MET (n=210) (0.40) 2.95 (0.40) 0.43 (-0.62, 1.49) PIO (n=138) (0.49) 3.70 (0.49) (-1.51, 0.88) SITA (n=143) (0.48) 2.61 (0.48) 0.77 (-0.41, 1.95) Abbreviations: CI = confidence interval; DTSQs = Diabetes Satisfaction Questionnaire (status version); EQW = exenatide once weekly; LOCF = last post-baseline measurement carried forward; LS mean = least-squares mean; MET = metformin; n = number of patients having both baseline and post-baseline data; N/A = not applicable; PIO = pioglitazone; SE = standard error; SITA = sitagliptin; vs. = versus. Note: Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included. Analysis of covariance (ANCOVA) model: Post-baseline Response Variable = + Baseline Response Variable + Pooled Country (Type III sums of squares). The two-sided 95% confidence interval is for the LS mean difference between Exenatide, MET, PIO and SITA.
9 Supplementary Table 8. EQ-5D Index Scores UK Population-based Index Score Endpoint (LOCF) Change from Baseline to Endpoint (LOCF) Comparison EQW vs. Comparators LS mean difference (95% CI) Between-group Comparison p-value EQW (n=232) 0.88 (0.01) 0.03 (0.01) N/A N/A MET (n=227) 0.88 (0.01) 0.03 (0.01) 0.00 (-0.02, 0.03) PIO (n=146) 0.84 (0.01) (0.01) 0.04 (0.01, 0.07) SITA (n=149) 0.87 (0.01) 0.02 (0.01) 0.02 (-0.02, 0.05) Abbreviations: CI = confidence interval; EQ-5D = EuroQol-5 dimensions; EQW = exenatide once weekly; LOCF = last postbaseline measurement carried forward; LS mean = least-squares mean; MET = metformin; n = number of patients having both baseline and post-baseline data; N/A = not applicable; PIO = pioglitazone; SE = standard error; SITA = sitagliptin; vs. = versus. Note: Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included. Analysis of covariance (ANCOVA) model: Post-baseline Response Variable = + Baseline Response Variable + Pooled Country (Type III sums of squares). The two-sided 95% confidence interval is for the LS mean difference between Exenatide, MET, PIO and SITA.
10 Supplementary Table 9. EQ-5D Index Scores US Population-based Index Score Endpoint (LOCF) Change from Baseline to Endpoint (LOCF) Comparison EQW vs. Comparators LS mean difference (95% CI) Between-group Comparison p-value EQW (n=232) 0.90 (0.01) 0.02 (0.01) N/A N/A MET (n=227) 0.91 (0.01) 0.02 (0.01) 0.00 (-0.02, 0.02) PIO (n=146) 0.88 (0.01) (0.01) 0.03 (0.00, 0.05) SITA (n=149) 0.89 (0.01) 0.01 (0.01) 0.01 (-0.01, 0.03) Abbreviations: CI = confidence interval; EQ-5D = EuroQol-5 dimensions; EQW = exenatide once weekly; LOCF = last postbaseline measurement carried forward; LS mean = least-squares mean; MET = metformin; n = number of patients having both baseline and post-baseline data; N/A = not applicable; PIO = pioglitazone; SE = standard error; SITA = sitagliptin; vs. = versus. Note: Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included. Analysis of covariance (ANCOVA) model: Post-baseline Response Variable = + Baseline Response Variable + Pooled Country (Type III sums of squares). The two-sided 95% confidence interval is for the LS mean difference between Exenatide,MET, PIO and SITA.
11 Supplementary Figure 1A. Mean (SE) 7-point SMBG at baseline (solid lines) and endpoint (LOCF) (dashed lines) with EQW (white circles) and MET (light gray squares). Postprandial was 2 hours after the start of the meal. Abbreviations: EQW = exenatide once weekly; LOCF = last observation carried forward; MET = metformin; SE = standard error; SMBG = self-monitored blood glucose.
12 Supplementary Figure 1B. Mean (SE) 7-point SMBG at baseline (solid lines) and endpoint (LOCF) (dashed lines) with EQW (white circles) and PIO (dark gray triangles). Postprandial was 2 hours after the start of the meal. Abbreviations: EQW = exenatide once weekly; LOCF = last observation carried forward; PIO = pioglitazone; SE = standard error; SMBG = selfmonitored blood glucose.
13 Supplementary Figure 1C. Mean (SE) 7-point SMBG at baseline (solid lines) and endpoint (LOCF) (dashed lines) with EQW (white circles) and SITA (black diamonds). Postprandial was 2 hours after the start of the meal. Abbreviations: EQW = exenatide once weekly; LOCF = last observation carried forward; SE = standard error; SITA = sitagliptin; SMBG = self-monitored blood glucose.
14 Supplementary Figures 2A-D. Changes in HbA 1c vs. changes in weight over 26 weeks. White circles = EQW; light gray squares = MET; dark gray triangles = PIO; white diamonds = SITA.
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