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Clinical Trial Details

Trial ID: L4830
Source ID: NCT02582814
Associated Drug: Dapagliflozin 5 Mg
Title: The Safety and Efficacy of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02582814/results
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: Dapagliflozin 5 mg|DRUG: Dapagliflozin 10mg
Outcome Measures: Primary: Overall Adverse Event Summary, To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy., From baseline to 52 weeks|Hypoglycemia, To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy., From baseline to 52 weeks|Diabetic Ketoacidosis (DKA), To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy., From baseline to 52 weeks|Vital Signs (Heart Rate), To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy., From baseline to 52 weeks|ECGs, To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy., From baseline to 52 weeks|Clinical Laboratory Measures, Urine Test Results (Any Marked Abnormality), To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy., From baseline to 52 weeks|Vital Signs (Blood Pressure), To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy., From baseline to 52 weeks | Secondary: Adjusted Change From Baseline in HbA1c, To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy., From baseline to 24/52 weeks|Adjusted Percent Change From Baseline in Total Daily Insulin Dose, To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy., From baseline to 24/52 weeks|Adjusted Percent Change From Baseline in Body Weight, To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy., From baseline to 24/52 weeks|Adjusted Change From Baseline in Glycoalbumin, To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy., From baseline to 24/52 weeks|Adjusted Change From Baseline in Average Daily Glucose Measured by 6-point SMBG, To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy., From baseline to 24/52 weeks|Adjusted Change From Baseline in Post-prandial Glucose Measured by 6-point SMBG, To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy., From baseline to 24/52 weeks|Proportion of Subjects Achieving HbA1c Reduction of 0.5 Percent Without Severe Hypoglycemia, To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin, From baseline to 24/52 weeks|Proportion of Subjects Achieving HbA1c Reduction of 0.5 Percent, To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin, From baseline to 24/52 weeks|Proportion of Subjects Achieving HbA1c < 7.0 Percent, To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin, From baseline to 24/52 weeks|Adjusted Change From Baseline in SBP in Subjects With Baseline SBP/DBP >= 140/90 mmHg, To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin, From baseline to 24/52 weeks
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 151
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-10-26
Completion Date: 2017-06-15
Results First Posted: 2019-04-12
Last Update Posted: 2019-04-12
Locations: Research Site, Aizu Wakamatsu-shi, Japan|Research Site, Chuo-ku, Japan|Research Site, Fukuoka-shi, Japan|Research Site, Fukuyama-shi, Japan|Research Site, Funabashi-shi, Japan|Research Site, Hamamatsu-shi, Japan|Research Site, Hirosaki-shi, Japan|Research Site, Ise-shi, Japan|Research Site, Kagoshima-shi, Japan|Research Site, Koriyama-shi, Japan|Research Site, Kumamoto-shi, Japan|Research Site, Kunitachi-shi, Japan|Research Site, Minato-ku, Japan|Research Site, Nagoya-shi, Japan|Research Site, Oita-shi, Japan|Research Site, Otsu-shi, Japan|Research Site, Oyama-shi, Japan|Research Site, Sapporo-shi, Japan|Research Site, Sendai-shi, Japan|Research Site, Shinjyuku-ku, Japan|Research Site, Suita-shi, Japan|Research Site, Tama-shi, Japan|Research Site, Tsukuba-shi, Japan|Research Site, Yokohama-shi, Japan
URL: https://clinicaltrials.gov/show/NCT02582814