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A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

2015年9月30日 更新者：AstraZeneca

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

915

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

  • アメリカ
    • Arizona
      • Tempe、Arizona、アメリカ、85282
        • Clinical Research Advantage / Desert Clinical Res, Llc
    • California
      • Encino、California、アメリカ、91436
        • Medical Group of Encino
      • Fresno、California、アメリカ、93720
        • Valley Research
      • Los Angeles、California、アメリカ、90023
        • Randall Shue, D.O.
      • Northridge、California、アメリカ、91325
        • Diabetes Medical Center Of California
      • San Diego、California、アメリカ、92117
        • Ritchken & First M.D.'S
      • Spring Valley、California、アメリカ、91978
        • Encompass Clinical Research
      • Torrance、California、アメリカ、90505
        • Raikhel, Marina
    • Colorado
      • Colorado Springs、Colorado、アメリカ、80909
        • Express Care Clinical Res
      • Denver、Colorado、アメリカ、80209
        • Denver Internal Medicine
      • Golden、Colorado、アメリカ、80401
        • New West Physicians
    • Florida
      • Altamonte Springs、Florida、アメリカ、32701
        • Central Florida Clinical Trials, Inc.
      • Chipley、Florida、アメリカ、32428
        • Family Care Associates Of Nw Florida
    • Minnesota
      • Minneapolis、Minnesota、アメリカ、56440
        • Health Partners Research Foundation
    • Missouri
      • Chesterfield、Missouri、アメリカ、63017
        • Woodlake Research
    • Nevada
      • Las Vegas、Nevada、アメリカ、89101
        • Nevada Alliance Against Diabetes
    • North Carolina
      • Morehead City、North Carolina、アメリカ、28557
        • Diabetes & Endocrinology Consultants, PC
    • Ohio
      • Newark、Ohio、アメリカ、43055
        • Newark Physician Associates
    • Oklahoma
      • Oklahoma City、Oklahoma、アメリカ、73159
        • Integris Family Care S. Penn
    • Pennsylvania
      • Carlisle、Pennsylvania、アメリカ、17013
        • Cumberland Valley Endocrinology Center, Llc
      • Pittsburgh、Pennsylvania、アメリカ、15216
        • Banksville Medical Pc
    • South Carolina
      • Summerville、South Carolina、アメリカ、29485
        • Palmetto Clinical Research
      • Taylors、South Carolina、アメリカ、29687
        • Southeastern Research Assoc
    • Texas
      • Houston、Texas、アメリカ、77081
        • Texas Center For Drug Development, P.A.
      • San Antonio、Texas、アメリカ、78229
        • Diabetes & Glandular Disease Research Associates, Inc.
      • San Antonio、Texas、アメリカ、78229
        • S.A.M. Clinical Research Center
    • Utah
      • Salt Lake City、Utah、アメリカ、84102
        • Optimum Clinical Research
    • Washington
      • Spokane、Washington、アメリカ、99216
        • Office Of Dr. Gray
  • アルゼンチン
      • Buenos Aires、アルゼンチン、1431
        • Local Institution
      • Cordoba、アルゼンチン、5000
        • Local Institution
    • Buenos Aires
      • Capital Federal、Buenos Aires、アルゼンチン、1034
        • Local Institution
      • Capital Federal、Buenos Aires、アルゼンチン、1429
        • Local Institution
      • Capital Federal、Buenos Aires、アルゼンチン、C1056ABJ
        • Local Institution
      • Capital Federal、Buenos Aires、アルゼンチン、C1425AGC
        • Local Institution
      • Ciudad Auton、Buenos Aires、アルゼンチン、C1408INH
        • Local Institution
      • Ciudad Auton.、Buenos Aires、アルゼンチン、C1505CWB
        • Local Institution
      • Mar Del Plata、Buenos Aires、アルゼンチン、7600
        • Local Institution
      • Zarate、Buenos Aires、アルゼンチン、2800
        • Local Institution
    • Cordoba
      • Villa Carlos Paz、Cordoba、アルゼンチン、5152
        • Local Institution
  • カナダ
    • Alberta
      • Calgary、Alberta、カナダ、T2R 0X7
        • Local Institution
    • British Columbia
      • Kelowna、British Columbia、カナダ、V1Y 2H4
        • Local Institution
    • Manitoba
      • Winnipeg、Manitoba、カナダ、R3E 3P4
        • Local Institution
    • New Brunswick
      • Bathurst、New Brunswick、カナダ、E2A 4X7
        • Local Institution
    • Newfoundland and Labrador
      • Mount Pearl、Newfoundland and Labrador、カナダ、A1N 1W7
        • Local Institution
      • St-John、Newfoundland and Labrador、カナダ、A1E 2E2
        • Local Institution
    • Ontario
      • Sarnia、Ontario、カナダ、N7T 4X3
        • Local Institution
      • Thornhill、Ontario、カナダ、L4J 8L7
        • Local Institution
      • Toronto、Ontario、カナダ、M4R 2G4
        • Local Institution
      • Toronto、Ontario、カナダ、M9W 4L6
        • Local Institution
    • Prince Edward Island
      • Charlottetown、Prince Edward Island、カナダ、C1A 5Y9
        • Local Institution
    • Quebec
      • Drummondville、Quebec、カナダ、J2B 7T1
        • Local Institution
      • Granby、Quebec、カナダ、J2G 8Z9
        • Local Institution
      • L'Ancienne Lorette、Quebec、カナダ、G2E 2X1
        • Local Institution
      • Mirabel、Quebec、カナダ、J7J 2K8
        • Local Institution
      • St-Leonard、Quebec、カナダ、H1S 3A9
        • Local Institution
    • Saskatchewan
      • Saskatoon、Saskatchewan、カナダ、S7K 3H3
        • Local Institution
      • Saskatoon、Saskatchewan、カナダ、S7K 7H9
        • Local Institution
  • ブラジル
      • Rio De Janeiro、ブラジル、20211
        • Local Institution
    • Ceara
      • Fortaleza、Ceara、ブラジル、60021
        • Local Institution
    • Minas Gerais
      • Itajuba、Minas Gerais、ブラジル、37502
        • Local Institution
    • Para
      • Belem、Para、ブラジル、66073
        • Local Institution
    • Rio Grande Do Sul
      • Caxias Do Sul、Rio Grande Do Sul、ブラジル、95070
        • Local Institution
      • Porto Alegre、Rio Grande Do Sul、ブラジル、90020090
        • Local Institution
      • Porto Alegre、Rio Grande Do Sul、ブラジル、90035
        • Local Institution
    • Sao Paulo
      • Marilia、Sao Paulo、ブラジル、17519
        • Local Institution
  • メキシコ
      • Durango、メキシコ、64710
        • Local Institution
    • Distrito Federal
      • Df、Distrito Federal、メキシコ、11800
        • Local Institution
      • Guadalajara、Distrito Federal、メキシコ、44670
        • Local Institution
      • Zapopan、Distrito Federal、メキシコ、45150
        • Local Institution
    • Jalisco
      • Guadalajara、Jalisco、メキシコ、44650
        • Local Institution
      • Guadalajara、Jalisco、メキシコ、44670
        • Local Institution
    • Nuevo Leon
      • Monterrey、Nuevo Leon、メキシコ、64710
        • Local Institution
      • Monterrey、Nuevo Leon、メキシコ、64460
        • Local Institution
      • Monterrrey、Nuevo Leon、メキシコ、64700
        • Local Institution
    • Tamaulipas
      • Tampico、Tamaulipas、メキシコ、89109
        • Local Institution

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

Key Inclusion Criteria

  • Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
  • Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
  • C-peptide ≥1.0 ng/mL
  • Body mass index ≤45.0 kg/m^2
  • Serum creatinine level <1.50 mg/dL for men or <1.40 mg/dL for women.

Key Exclusion Criteria

  • Aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper limit of normal
  • Serum total bilirubin level >2 mg/dL
  • Creatinine kinase level >3 times upper limit of normal
  • Symptoms of severely uncontrolled diabetes
  • Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women
  • Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, 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
プラセボコンパレーター：Placebo + Metformin
Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
薬：Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
薬：Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
実験的：Dapagliflozin, 2.5 mg + Metformin
Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
薬：Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
薬：Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
他の名前：
  • BMS-512148
実験的：Dapagliflozin, 5 mg + Metformin
Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
薬：Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
薬：Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
他の名前：
  • BMS-512148
実験的：Dapagliflozin, 10 mg + Metformin
Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
薬：Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
薬：Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
薬：Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
他の名前：
  • BMS-512148

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
24 週目のヘモグロビン A1C (HbA1c) のベースラインからの調整平均変化 (最終観察値繰り越し [LOCF])
時間枠：ベースラインから 24 週目まで
HbA1c は中央検査機関によってヘモグロビンのパーセントとして測定されました。 救急投薬後のデータはこの分析から除外されました。 ベースラインは、二重盲検治験薬の初回投与の開始日時前の最後の評価として定義されました。 最初の投与の時間または評価の時間が利用できない場合、ベースラインは、二重盲検試験薬の最初の投与日またはそれ以前の最後の評価として定義されました。 HbA1c 測定は、認定期間および導入期間中、ならびに二重盲検期間の 1 日目および 4、8、12、16、20、および 24 週目に取得されました。
ベースラインから 24 週目まで

二次結果の測定

結果測定
メジャーの説明
時間枠
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
時間枠：From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured as 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 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.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])
時間枠：From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication 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 measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
From Baseline to Week 24
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
時間枠：From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])
時間枠：From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c > 9.0%. Data after rescue medication were 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.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])
時間枠：From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.) Data after rescue medication 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 measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])
時間枠：From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were 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.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])
時間枠：From Baseline to Week 1
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. 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.
From Baseline to Week 1
Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])
時間枠：From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
From Baseline to Week 24

その他の成果指標

結果測定
メジャーの説明
時間枠
Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation
時間枠：From Baseline to end of Long-term Period (Week 102)
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. Related=having certain, probable, possible, or missing relationship to study drug. Events captured from baseline to last dose plus 4 days for AEs and plus 30 days for SAEs during the double-blind 12-week period. Data after rescue included.
From Baseline to end of Long-term Period (Week 102)
Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality
時間枠：Day 1 to Week 102
BUN=blood urea nitrogen; preRX=pretreatment; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Phosphorus, inorganic (low): ages 17-65 years, ≤1.8 mg/dL; ages≥66 years, ≤2.1 mg/dL. Phosphorus, inorganic (high): ages 17-65 years, ≥5.6 mg/dL; ages≥66 years, ≥5.6 mg/dL. Phosphorus, inorganic (low) ≤1.8 mg/dL if age 17-65 or ≤2.1 mg/dL if age ≥66. Calcium, total (high): ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRx value.
Day 1 to Week 102
Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])
時間枠：Baseline to Week 102
12-Lead electrocardiograms (ECGs) were performed at entry into lead-in period Day -7 visit and Week 24/dnd of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter. Data after rescue included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available.
Baseline to Week 102
Mean Changes From Baseline in Seated Systolic Blood Pressure
時間枠：From Baseline to Week 102
Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. 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.
From Baseline to Week 102
Mean Changes From Baseline in Seated Diastolic Blood Pressure
時間枠：From Baseline to Week 102
Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. 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.
From Baseline to Week 102
Number of Participants With Orthostatic Hypotension
時間枠：From Baseline to Week 102
Orthostatic hypotension was defined as a decrease from supine to standing blood pressure of >20 mm Hg in systolic blood pressure or >10 mm Hg in diastolic blood pressure.
From Baseline to Week 102

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

AstraZeneca

協力者

Bristol-Myers Squibb

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。

一般刊行物

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

2007年9月1日

一次修了 (実際)

2008年11月1日

研究の完了 (実際)

2010年5月1日

試験登録日

最初に提出

2007年9月11日

QC基準を満たした最初の提出物

2007年9月11日

最初の投稿 (見積もり)

2007年9月12日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年10月20日

QC基準を満たした最後の更新が送信されました

2015年9月30日

最終確認日

2015年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • MB102-014 LT
  • MB102-014 (その他の識別子：Other Study ID Numbers:)

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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。

2型糖尿病の臨床試験

Placeboの臨床試験

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条件

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ダイエットサプリメント

スポンサー/協力者

場所

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