Clinical Trial Details
| Trial ID: | L7270 |
| Source ID: | NCT03199053 |
| Associated Drug: | Dapagliflozin |
| Title: | Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT03199053/results |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Dapagliflozin|DRUG: Saxagliptin|DRUG: Placebo |
| Outcome Measures: | Primary: Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26, Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on multiple imputation washout (MI-WO) within each arm using the data from placebo participants with Week 26 data., Baseline and Week 26|Saxagliptin Versus Placebo: Adjusted Mean Change From Baseline in HbA1c at Week 26, Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data., Baseline and Week 26 | Secondary: Dapagliflozin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26, Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Dapagliflozin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1., Baseline and Week 26|Saxagliptin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26, Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Saxagliptin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1., Baseline and Week 26|Dapagliflozin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26, Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Dapagliflozin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1., Baseline and Week 26|Saxagliptin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in HbA1c at Week 26, Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Saxagliptin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1., Baseline and Week 26|Dapagliflozin Versus Placebo: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26, Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data., Baseline and Week 26|Saxagliptin Versus Placebo: Adjusted Mean Change From Baseline in FPG at Week 26, Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data., Baseline and Week 26|Dapagliflozin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26, Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Dapagliflozin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1., Baseline and Week 26|Saxagliptin Low-dose/High-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26, Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Saxagliptin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1., Baseline and Week 26|Dapagliflozin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26, Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Dapagliflozin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1., Baseline and Week 26|Saxagliptin Low-dose Versus Placebo (Weighted): Adjusted Mean Change From Baseline in FPG at Week 26, Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Saxagliptin participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1., Baseline and Week 26|Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26, A logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data., Baseline and Week 26|Low-dose/High-dose Versus Placebo (Weighted): Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26, A weighted logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 0; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 2; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1., Baseline and Week 26|Low-dose Versus Placebo (Weighted): Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26, A weighted logistic regression model adjusting for sex, age group, background antidiabetes medication and Baseline HbA1c was used. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data. Participants were weighted as follows: participants who had HbA1c \< 7% at Week 12 and remained on low-dose were assigned a weight of 1; participants who had HbA1c \>= 7% at Week 12 and continued on the low-dose were assigned a weight of 2; participants who had HbA1c \>= 7% at Week 12 and received the high-dose were assigned a weight of 0; all participants who do not undergo second randomisation were assigned a weight of 1. Placebo participants were assigned a weight of 1., Baseline and Week 26|Low-dose Versus Uptitration to the High Dose: Adjusted Mean Change From Baseline in HbA1c at Week 26, Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline HbA1c as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data., Baseline and Week 26|Low-dose Versus Uptitration to the High Dose: Adjusted Mean Change From Baseline in FPG at Week 26, Data was analysed with an ANCOVA model with treatment, sex, age group and background antidiabetes medication as factors and Baseline FPG as covariate. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data., Baseline and Week 26|Dapagliflozin Low-dose Versus Uptitration to the High Dose: Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26, A Fisher's exact test was used and unadjusted difference in percentage of participants and Clopper-Pearson CIs presented using imputed data. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data., Baseline and Week 26|Saxagliptin Low-dose Versus Uptitration to the High Dose: Percentage of Participants With Baseline HbA1c ≥ 7% Who Achieved HbA1c < 7% at Week 26, A Fisher's exact test was used and unadjusted difference in percentage of participants and Clopper-Pearson CIs presented using imputed data. Missing Week 26 data was handled based on MI-WO within each arm using the data from placebo participants with Week 26 data., Baseline and Week 26 |
| Sponsor/Collaborators: | Sponsor: AstraZeneca |
| Gender: | ALL |
| Age: | CHILD, ADULT |
| Phases: | PHASE3 |
| Enrollment: | 256 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2017-10-11 |
| Completion Date: | 2024-01-03 |
| Results First Posted: | 2024-04-17 |
| Last Update Posted: | 2024-06-21 |
| Locations: | Research Site, Sacramento, California, 95821, United States|Research Site, New Haven, Connecticut, 06519, United States|Research Site, Hialeah, Florida, 33012, United States|Research Site, Hialeah, Florida, 33016, United States|Research Site, Hollywood, Florida, 33021, United States|Research Site, Miami Springs, Florida, 33166, United States|Research Site, Miami, Florida, 33144, United States|Research Site, Miami, Florida, 33155, United States|Research Site, Miami, Florida, 33165, United States|Research Site, Atlanta, Georgia, 30322, United States|Research Site, Atlanta, Georgia, 30341, United States|Research Site, Idaho Falls, Idaho, 83404, United States|Research Site, Neptune, New Jersey, 07753, United States|Research Site, Memphis, Tennessee, 38116, United States|Research Site, Memphis, Tennessee, 38119, United States|Research Site, Edinburg, Texas, 78539, United States|Research Site, Harlingen, Texas, 78550, United States|Research Site, McAllen, Texas, 78503, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, Charlottesville, Virginia, 22903, United States|Research Site, Buenos Aires, 6500, Argentina|Research Site, Buenos Aires, C1180AAX, Argentina|Research Site, Caba, C1119ACN, Argentina|Research Site, Ciudad de Buenos Aires, C1405BCH, Argentina|Research Site, San Miguel de Tucuman, 4000, Argentina|Research Site, San Miguel de Tucumán, 4000, Argentina|Research Site, San Miguel de Tucumán, T4000IHE, Argentina|Research Site, Blacktown, 2148, Australia|Research Site, Brasilia, 71625-009, Brazil|Research Site, Curitiba, 80810-040, Brazil|Research Site, Fortaleza, 60170-320, Brazil|Research Site, Fortaleza, 60430-270, Brazil|Research Site, Passo Fundo, 99010-080, Brazil|Research Site, Porto Alegre, 90430-001, Brazil|Research Site, Porto Alegre, 91350-250, Brazil|Research Site, Ribeirão Preto, 14051-104, Brazil|Research Site, Santa Maria, 97015-530, Brazil|Research Site, Sao Paulo, 01223-001, Brazil|Research Site, Sao Paulo, 05652-900, Brazil|Research Site, Montreal, Quebec, H1T 2M4, Canada|Research Site, Santiago, 7500710, Chile|Research Site, Armenia, 630004, Colombia|Research Site, Barranquilla, 80020, Colombia|Research Site, Tampere, 33520, Finland|Research Site, Ahmedabad, 380008, India|Research Site, Aurangabad, 431003, India|Research Site, Bangalore, 560002, India|Research Site, Bikaner, 334003, India|Research Site, Chandigarh, 160012, India|Research Site, Coimbatore, 641009, India|Research Site, Hyderabad, 500012, India|Research Site, Kolkata, 700054, India|Research Site, Kozhikode, 67300, India|Research Site, Nashik, 422002, India|Research Site, Pune, 411030, India|Research Site, Visakhapatnam, 531011, India|Research Site, Haifa, 3109601, Israel|Research Site, Ancona, 60123, Italy|Research Site, Napoli, 80138, Italy|Research Site, Roma, 00165, Italy|Research Site, Daejeon-si, 35233, Korea, Republic of|Research Site, Incheon, 22332, Korea, Republic of|Research Site, Wonju-si, 26426, Korea, Republic of|Research Site, George Town, 10450, Malaysia|Research Site, Ipoh, 30990, Malaysia|Research Site, Johor Bahru, 80100, Malaysia|Research Site, Klang, 41200, Malaysia|Research Site, Kota Kinabalu, 88996, Malaysia|Research Site, Kuala Lumpur, 50586, Malaysia|Research Site, Kuching, 93586, Malaysia|Research Site, Melaka, 75400, Malaysia|Research Site, Putrajaya, 62250, Malaysia|Research Site, Seremban, 70300, Malaysia|Research Site, Seri Manjung, 32040, Malaysia|Research Site, Taiping, 34000, Malaysia|Research Site, Boca del Rio, 94290, Mexico|Research Site, Celaya, 38000, Mexico|Research Site, Ciudad Madero, 89440, Mexico|Research Site, Cuernavaca, 62209, Mexico|Research Site, Cuernavaca, 62290, Mexico|Research Site, Culiacán, 80230, Mexico|Research Site, Durango, 34000, Mexico|Research Site, Guadalajara, 44150, Mexico|Research Site, Juriquilla, 76230, Mexico|Research Site, Merida, 97000, Mexico|Research Site, Mexico, 06700, Mexico|Research Site, Monterrey, 64460, Mexico|Research Site, Monterrey, 64620, Mexico|Research Site, México, D.F., 11410, Mexico|Research Site, San Juan del Rio, 76800, Mexico|Research Site, Veracruz, 91900, Mexico|Research Site, Zapopan, 45116, Mexico|Research Site, Grafton, 1023, New Zealand|Research Site, Tauranga, 3110, New Zealand|Research Site, Wellington, 6021, New Zealand|Research Site, Quezon City, 1100, Philippines|Research Site, Quezon City, 1112, Philippines|Research Site, San Fernando City, 2000, Philippines|Research Site, Warszawa, 01-868, Poland|Research Site, Izhevsk, 426009, Russian Federation|Research Site, Moscow, 125993, Russian Federation|Research Site, Ufa, 450000, Russian Federation|Research Site, Tainan City, 704, Taiwan|Research Site, Taipei, 112, Taiwan|Research Site, Bangkok, 10400, Thailand|Research Site, Hat Yai, 90110, Thailand|Research Site, Aydin, 9010, Turkey|Research Site, Bursa, 16059, Turkey|Research Site, Eskisehir, 26480, Turkey|Research Site, Istanbul, 34020, Turkey|Research Site, Izmir, 35210, Turkey|Research Site, Izmir, 35330, Turkey|Research Site, Kocaeli, 41380, Turkey|Research Site, Kurupelit, 55139, Turkey|Research Site, Manisa, 45030, Turkey|Research Site, Dnipro, 49023, Ukraine|Research Site, Kyiv, 01021, Ukraine|Research Site, Vinnytsia, 21010, Ukraine|Research Site, Birmingham, B4 6NH, United Kingdom|Research Site, London, E1 1BB, United Kingdom|Research Site, London, SE5 9RS, United Kingdom|Research Site, Middlesborough, TS4 3BW, United Kingdom|Research Site, Nottingham, NG7 2UH, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT03199053 |
