Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes
2017年4月18日 更新者：AstraZeneca
A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on diet and exercise alone.
The safety of this treatment will also be studied
調査の概要
研究の種類
介入
入学 (実際)
497
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Arizona
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Litchfield Park、Arizona、アメリカ、85340
- Dedicated Clinical Research
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Phoenix、Arizona、アメリカ、85051
- 43rd Medical Associates, P.C.
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Tempe、Arizona、アメリカ、85282
- Clinical Research Advantage, Inc.
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California
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Fresno、California、アメリカ、93720
- Valley Research
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Lomita、California、アメリカ、90717
- Marina Raikhel, Md, Faafp
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Los Gatos、California、アメリカ、95032
- Richard S. Cherlin, MD
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Tustin、California、アメリカ、92780
- Orange County Research Center
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Colorado
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Greeley、Colorado、アメリカ、80634
- Family Physicians Of Greeley
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Connecticut
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New London、Connecticut、アメリカ、06320
- Coastal Connecticut Research, LLC
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Florida
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Altamonte Springs、Florida、アメリカ、32701
- Central Florida Clinical Trials, Inc.
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Jacksonville、Florida、アメリカ、32205
- Westside Center for Clinical Research
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Marianna、Florida、アメリカ、32446
- Panhandle Family Care Associates
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Georgia
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Roswell、Georgia、アメリカ、30076
- Endocrine Research Solutions, Inc.
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Mississippi
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Belzoni、Mississippi、アメリカ、39038
- Belzoni Clinical Research
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New Jersey
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Hamilton、New Jersey、アメリカ、08690
- R-Research
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New York
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Syracuse、New York、アメリカ、13210
- Internist Associates Of Central New York
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West Seneca、New York、アメリカ、14224
- Southgate Medical Group
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North Carolina
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Morehead City、North Carolina、アメリカ、28557
- Down East Medical Associates, PA
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Ohio
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Akron、Ohio、アメリカ、44319
- James J. Brown, Md
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Oklahoma
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Oklahoma、Oklahoma、アメリカ、73170
- Integris Family Care South
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South Carolina
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Taylors、South Carolina、アメリカ、29687
- Southeastern Research Associates, Inc.
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Texas
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San Antonio、Texas、アメリカ、78224
- Abbott Clinical Research Group, Inc
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Utah
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Midvale、Utah、アメリカ、84047
- Avastra Clinical Trials
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Salt Lake City、Utah、アメリカ、84102
- Optimum Clinical Research, Inc.
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Washington
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Olympia、Washington、アメリカ、98502
- Capital Clinical Research Center
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Spokane、Washington、アメリカ、99216
- Stephen G. Danley, Do
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Ahmedabad、インド、380 015
- Local Institution
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Bangalore、インド、560 043
- Local Institution
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Bangalore、インド、560 052
- Local Institution
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Jaipur、インド、302001
- Local Institution
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Jaipur、インド、302016
- Local Institution
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Alberta
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Calgary、Alberta、カナダ、T3C 3P1
- Local Institution
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British Columbia
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Coquitlam、British Columbia、カナダ、V3K 3V9
- Local Institution
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Manitoba
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Winnipeg、Manitoba、カナダ、R3E 3P4
- Local Institution
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New Brunswick
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Bathurst、New Brunswick、カナダ、E2A 4X7
- Local Institution
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Ontario
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Ajax、Ontario、カナダ、L1S 7J5
- Local Institution
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Toronto、Ontario、カナダ、M9W 4L6
- Local Institution
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Waterloo、Ontario、カナダ、N2T 2Z6
- Local Institution
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Quebec
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Drummondville、Quebec、カナダ、J2B 7T1
- Local Institution
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L'Ancienne Lorette、Quebec、カナダ、G2E 2X1
- Local Institution
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St-Leonard、Quebec、カナダ、H1S 3A9
- Local Institution
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Ponce、プエルトリコ、00716
- Local Institution
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Ponce、プエルトリコ、00717
- Local Institution
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Durango、メキシコ、34000
- Local Institution
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Mexico City、メキシコ、06700
- Local Institution
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Veracruz、メキシコ、91910
- Local Institution
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Distrito Federal
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Df、Distrito Federal、メキシコ、11800
- Local Institution
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Jalisco
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Guadalajara、Jalisco、メキシコ、44670
- Local Institution
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Nuevo Leon
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Monterrey、Nuevo Leon、メキシコ、64060
- Local Institution
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Yucatan
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Merida、Yucatan、メキシコ、97070
- Local Institution
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Kursk、ロシア連邦、305035
- Local Institution
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Saint-Petersburg、ロシア連邦、191015
- Local Institution
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Saratov、ロシア連邦、410012
- Local Institution
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Smolensk、ロシア連邦、214018
- Local Institution
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St. Petersburg、ロシア連邦、195112
- Local Institution
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St. Petersburg、ロシア連邦、195257
- Local Institution
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St. Petersburg、ロシア連邦、197341
- Local Institution
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St.Petersburg、ロシア連邦、197022
- Local Institution
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Gauteng
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Benoni、Gauteng、南アフリカ、1501
- Local Institution
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Soweto、Gauteng、南アフリカ、1818
- Local Institution
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Western Cape
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Paarl、Western Cape、南アフリカ、7646
- Local Institution
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Tygerberg、Western Cape、南アフリカ、7505
- Local Institution
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～77年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
- Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
- C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
- Body Mass Index ≤ 45 kg/m²
- Must be able to perform self monitoring of blood glucose
Exclusion Criteria:
- aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3* upper limit of normal (ULN)
- Serum Total bilirubin >2 mg/dL (34.2 µmol/L)
- Creatinine kinase >3* ULN
- Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Dapagliflozin 1 mg
Dapagliflozin: 1 mg
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Tablets, Oral, Once Daily, Up to 24 weeks
他の名前：
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実験的：Dapagliflozin 2.5 mg
Dapagliflozin: 2.5 mg
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Tablets, Oral, Once Daily, Up to 24 weeks
他の名前：
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実験的：Dapagliflozin 5 mg
Dapagliflozin: 5 mg
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Tablets, Oral, Once Daily, Up to 24 weeks
他の名前：
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プラセボコンパレーター：Placebo
Placebo: 0 mg
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Tablets, Oral, Once Daily, Up to 24 weeks
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants
時間枠：Baseline (Day 1), Week 24
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Adjusted mean change in HbA1c from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined(LOCF).
HbA1c was measured as percent of hemoglobin by a central laboratory.
Data after rescue medication (metformin) was excluded from this analysis.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication.
In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
HbA1c values were obtained at enrollment, lead-in, and at Day 1, Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.
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Baseline (Day 1), Week 24
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants
時間枠：Baseline (Day 1), Week 24
|
Adjusted mean change in total body weight from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available LOCF was determined.
Data after rescue medication (metformin) was excluded from this analysis.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication.
In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
Body weight was measured in kilograms (kg) at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period.
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Baseline (Day 1), Week 24
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Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants
時間枠：Baseline (Day 1), Week 24
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Adjusted mean change in fasting plasma glucose (FPG) from baseline at Week 24 (LOCF) was determined.
Data after rescue medication (metformin) was excluded from this analysis.
FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication.
In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
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Baseline (Day 1), Week 24
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Adjusted Mean Change From Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants
時間枠：Baseline (Day 1), Week 24
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Liquid meal tolerance tests (MTTs) were scheduled to occur at Day 1 visit (MTT was to be completed 2 hours prior to first dose of treatment) and at Week 24 / End of treatment visit, or Rescue visit for participants meeting criteria for rescue due to lack of glycemic control.
At Week 24, study treatment was given 1 hour before MTT was administered.
Participant fasted for at least 10 hours (h) prior to both visits and abstained from tobacco, alcohol, and caffeine for 24 h prior to the MTT.
The liquid meal supplement was administered over 10 minutes, starting immediately after Time 0 blood sample was drawn.
Blood samples for post-liquid meal Glucose were obtained at 30, 60, 120, and 180 minutes after ingesting the liquid supplement.
Glucose was measured in milligrams per deciliter (mg/dL) by a central laboratory.
Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study medication.
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Baseline (Day 1), Week 24
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Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants
時間枠：Baseline (Day 1), Week 24
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Therapeutic glycemic response was defined as HbA1c less than 7.0%.
n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values.
Percent=n/N and was adjusted for Baseline HbA1c.
Data after rescue medication (metformin) was excluded from this analysis.
HbA1c was measured as a percent of hemoglobin.
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Baseline (Day 1), Week 24
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Adjusted Mean Change From Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants
時間枠：Baseline (Day 1), Week 24
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Adjusted mean waist circumference values from baseline to Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, last observation carried forward, (LOCF) was determined.
Data after rescue medication (metformin) was excluded from this analysis.
Waist circumference was measured centimeters (cm) and obtained at lead-in, Day 1, and Week 24 of the double-blind period.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication.
In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
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Baseline (Day 1), Week 24
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Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
時間枠：Day 1 of Double Blind Period to end of Week 24 Plus 30 days
|
Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator.
Baseline to last dose plus 4 days for AEs, plus 30 days for SAEs.
Data after rescue included.
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Day 1 of Double Blind Period to end of Week 24 Plus 30 days
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Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
時間枠：Baseline to last dose plus 4 days in 12 Week Double Blind Period
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Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 12.1.
Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs were prior to rescue.
Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.
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Baseline to last dose plus 4 days in 12 Week Double Blind Period
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Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue - Treated Participants
時間枠：Baseline (Day 1), Week 24
|
Blood pressure values were obtained on Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double blind period, after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study.
Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine.
Blood pressure was measured in millimeters of mercury (mmHg).
Data after rescue were also included.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication.
In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
|
Baseline (Day 1), Week 24
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Mean Change From Baseline in Seated Heart Rate at Week 24 - Treated Participants
時間枠：Baseline (Day 1), Week 24
|
Heart rate values were obtained after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study.
Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine.
Heart rate was measured in beats per minute (bpm).
Data after rescue were also included.
Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication.
In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
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Baseline (Day 1), Week 24
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Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants
時間枠：Week 24
|
12-Lead electrocardiograms (ECGs) were performed at Day -14 and Week 24/End of treatment visit (last observation carried forward) on participants who were supine.
ECGs were assessed by the investigator.
Baseline (BL) was Day -14 for this parameter.
|
Week 24
|
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Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
時間枠：Baseline to Week 24/end of treatment plus 4 days
|
Safety laboratory measurements were obtained at Day 1, Weeks 1, 2, 4, 8, 12, 20, and 24 in the double blind Period.
Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication.
Data included from baseline up to and including the last day of treatment plus 4 days.
Data after rescue was also included.
Abbreviations; Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP); blood urea nitrogen (BUN).
Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); BUN (>60 mg/dL) or Urea >21.4 mmol/L; creatinine (>=1.5*preRX,
>=2.5 mg/dL); AST and ALT >3*ULN; bilirubin >1.5*ULN; ALP >1.5*ULN.
|
Baseline to Week 24/end of treatment plus 4 days
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2008年9月22日
一次修了 (実際)
2009年12月29日
研究の完了 (実際)
2009年12月29日
試験登録日
最初に提出
2008年8月15日
QC基準を満たした最初の提出物
2008年8月15日
最初の投稿 (見積もり)
2008年8月18日
学習記録の更新
投稿された最後の更新 (実際)
2017年4月20日
QC基準を満たした最後の更新が送信されました
2017年4月18日
最終確認日
2017年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。