30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks
A Randomised, Double-blind Parallel Group Study to Compare the Efficacy and Safety of Initial Combination Therapy With Linagliptin 5 mg + Pioglitazone 15 mg, 30 mg, or 45 mg, vs. Monotherapy With Pioglitazone (15 mg, 30 mg, or 45 mg) or Linagliptin 5 mg Once Daily for 30 Weeks, Followed by a Blinded Trial Period on Linagliptin 5 mg + Pioglitazone 30 or 45 mg Versus Pioglitazone Monotherapy 30 or 45 mg or Linagliptin 5 mg for up to 54 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control on Diet and Exercise
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ
- 1264.3.01026 Boehringer Ingelheim Investigational Site
-
Montgomery、Alabama、アメリカ
- 1264.3.01021 Boehringer Ingelheim Investigational Site
-
Muscle Shoals、Alabama、アメリカ
- 1264.3.01020 Boehringer Ingelheim Investigational Site
-
-
Arizona
-
Chandler、Arizona、アメリカ
- 1264.3.01062 Boehringer Ingelheim Investigational Site
-
Mesa、Arizona、アメリカ
- 1264.3.01064 Boehringer Ingelheim Investigational Site
-
-
California
-
Carmichael、California、アメリカ
- 1264.3.01049 Boehringer Ingelheim Investigational Site
-
Chino、California、アメリカ
- 1264.3.01078 Boehringer Ingelheim Investigational Site
-
Concord、California、アメリカ
- 1264.3.01031 Boehringer Ingelheim Investigational Site
-
Lakewood、California、アメリカ
- 1264.3.01037 Boehringer Ingelheim Investigational Site
-
Los Angeles、California、アメリカ
- 1264.3.01065 Boehringer Ingelheim Investigational Site
-
Norwalk、California、アメリカ
- 1264.3.01006 Boehringer Ingelheim Investigational Site
-
Rancho Cucamonga、California、アメリカ
- 1264.3.01001 Boehringer Ingelheim Investigational Site
-
San Diego、California、アメリカ
- 1264.3.01059 Boehringer Ingelheim Investigational Site
-
Tarzana、California、アメリカ
- 1264.3.01023 Boehringer Ingelheim Investigational Site
-
Tustin、California、アメリカ
- 1264.3.01016 Boehringer Ingelheim Investigational Site
-
Valencia、California、アメリカ
- 1264.3.01058 Boehringer Ingelheim Investigational Site
-
Westlake Village、California、アメリカ
- 1264.3.01083 Boehringer Ingelheim Investigational Site
-
-
Colorado
-
Denver、Colorado、アメリカ
- 1264.3.01027 Boehringer Ingelheim Investigational Site
-
-
Connecticut
-
Norwalk、Connecticut、アメリカ
- 1264.3.01033 Boehringer Ingelheim Investigational Site
-
-
Florida
-
Boca Raton、Florida、アメリカ
- 1264.3.01035 Boehringer Ingelheim Investigational Site
-
Clearwater、Florida、アメリカ
- 1264.3.01015 Boehringer Ingelheim Investigational Site
-
Hialeah、Florida、アメリカ
- 1264.3.01082 Boehringer Ingelheim Investigational Site
-
Jacksonville、Florida、アメリカ
- 1264.3.01036 Boehringer Ingelheim Investigational Site
-
Longwood、Florida、アメリカ
- 1264.3.01013 Boehringer Ingelheim Investigational Site
-
Miami、Florida、アメリカ
- 1264.3.01038 Boehringer Ingelheim Investigational Site
-
Miami、Florida、アメリカ
- 1264.3.01042 Boehringer Ingelheim Investigational Site
-
Miami、Florida、アメリカ
- 1264.3.01079 Boehringer Ingelheim Investigational Site
-
Port Orange、Florida、アメリカ
- 1264.3.01019 Boehringer Ingelheim Investigational Site
-
St. Cloud、Florida、アメリカ
- 1264.3.01018 Boehringer Ingelheim Investigational Site
-
Tampa、Florida、アメリカ
- 1264.3.01009 Boehringer Ingelheim Investigational Site
-
Tampa、Florida、アメリカ
- 1264.3.01012 Boehringer Ingelheim Investigational Site
-
-
Georgia
-
Atlanta、Georgia、アメリカ
- 1264.3.01008 Boehringer Ingelheim Investigational Site
-
Atlanta、Georgia、アメリカ
- 1264.3.01055 Boehringer Ingelheim Investigational Site
-
Atlanta、Georgia、アメリカ
- 1264.3.01061 Boehringer Ingelheim Investigational Site
-
Blue Ridge、Georgia、アメリカ
- 1264.3.01074 Boehringer Ingelheim Investigational Site
-
Cartersville、Georgia、アメリカ
- 1264.3.01084 Boehringer Ingelheim Investigational Site
-
Perry、Georgia、アメリカ
- 1264.3.01060 Boehringer Ingelheim Investigational Site
-
Savannah、Georgia、アメリカ
- 1264.3.01050 Boehringer Ingelheim Investigational Site
-
-
Illinois
-
Chicago、Illinois、アメリカ
- 1264.3.01077 Boehringer Ingelheim Investigational Site
-
-
Indiana
-
Brownsburg、Indiana、アメリカ
- 1264.3.01052 Boehringer Ingelheim Investigational Site
-
Evansville、Indiana、アメリカ
- 1264.3.01075 Boehringer Ingelheim Investigational Site
-
Evansville、Indiana、アメリカ
- 1264.3.01076 Boehringer Ingelheim Investigational Site
-
Franklin、Indiana、アメリカ
- 1264.3.01073 Boehringer Ingelheim Investigational Site
-
-
Kansas
-
Wichita、Kansas、アメリカ
- 1264.3.01002 Boehringer Ingelheim Investigational Site
-
Wichita、Kansas、アメリカ
- 1264.3.01007 Boehringer Ingelheim Investigational Site
-
-
Kentucky
-
Lexington、Kentucky、アメリカ
- 1264.3.01010 Boehringer Ingelheim Investigational Site
-
-
Louisiana
-
New Orleans、Louisiana、アメリカ
- 1264.3.01028 Boehringer Ingelheim Investigational Site
-
Sunset、Louisiana、アメリカ
- 1264.3.01029 Boehringer Ingelheim Investigational Site
-
-
Maryland
-
Hyattsville、Maryland、アメリカ
- 1264.3.01069 Boehringer Ingelheim Investigational Site
-
-
Michigan
-
Southfield、Michigan、アメリカ
- 1264.3.01066 Boehringer Ingelheim Investigational Site
-
-
Montana
-
Great Falls、Montana、アメリカ
- 1264.3.01057 Boehringer Ingelheim Investigational Site
-
-
North Carolina
-
Burlington、North Carolina、アメリカ
- 1264.3.01045 Boehringer Ingelheim Investigational Site
-
Charlotte、North Carolina、アメリカ
- 1264.3.01044 Boehringer Ingelheim Investigational Site
-
-
Ohio
-
Zanesville、Ohio、アメリカ
- 1264.3.01022 Boehringer Ingelheim Investigational Site
-
-
Oklahoma
-
Oklahoma City、Oklahoma、アメリカ
- 1264.3.01032 Boehringer Ingelheim Investigational Site
-
-
Pennsylvania
-
Fleetwood、Pennsylvania、アメリカ
- 1264.3.01051 Boehringer Ingelheim Investigational Site
-
Pittsburgh、Pennsylvania、アメリカ
- 1264.3.01025 Boehringer Ingelheim Investigational Site
-
-
South Carolina
-
Columbia、South Carolina、アメリカ
- 1264.3.01081 Boehringer Ingelheim Investigational Site
-
Greer、South Carolina、アメリカ
- 1264.3.01003 Boehringer Ingelheim Investigational Site
-
-
Tennessee
-
Kingsport、Tennessee、アメリカ
- 1264.3.01011 Boehringer Ingelheim Investigational Site
-
-
Texas
-
Corpus Christi、Texas、アメリカ
- 1264.3.01017 Boehringer Ingelheim Investigational Site
-
Dallas、Texas、アメリカ
- 1264.3.01067 Boehringer Ingelheim Investigational Site
-
Houston、Texas、アメリカ
- 1264.3.01004 Boehringer Ingelheim Investigational Site
-
Houston、Texas、アメリカ
- 1264.3.01039 Boehringer Ingelheim Investigational Site
-
Houston、Texas、アメリカ
- 1264.3.01041 Boehringer Ingelheim Investigational Site
-
Houston、Texas、アメリカ
- 1264.3.01047 Boehringer Ingelheim Investigational Site
-
Houston、Texas、アメリカ
- 1264.3.01070 Boehringer Ingelheim Investigational Site
-
Killeen、Texas、アメリカ
- 1264.3.01040 Boehringer Ingelheim Investigational Site
-
Midland、Texas、アメリカ
- 1264.3.01048 Boehringer Ingelheim Investigational Site
-
New Braunfels、Texas、アメリカ
- 1264.3.01030 Boehringer Ingelheim Investigational Site
-
North Richland Hills、Texas、アメリカ
- 1264.3.01071 Boehringer Ingelheim Investigational Site
-
Plano、Texas、アメリカ
- 1264.3.01085 Boehringer Ingelheim Investigational Site
-
San Antonio、Texas、アメリカ
- 1264.3.01046 Boehringer Ingelheim Investigational Site
-
-
Virginia
-
Norfolk、Virginia、アメリカ
- 1264.3.01056 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Annan、イギリス
- 1264.3.44032 Boehringer Ingelheim Investigational Site
-
Ash Vale, Aldershot、イギリス
- 1264.3.44028 Boehringer Ingelheim Investigational Site
-
Baillieston, Glasgow、イギリス
- 1264.3.44029 Boehringer Ingelheim Investigational Site
-
Balham、イギリス
- 1264.3.44008 Boehringer Ingelheim Investigational Site
-
Bradford on Avon、イギリス
- 1264.3.44021 Boehringer Ingelheim Investigational Site
-
Burbage、イギリス
- 1264.3.44019 Boehringer Ingelheim Investigational Site
-
Chesterfield、イギリス
- 1264.3.44012 Boehringer Ingelheim Investigational Site
-
Chestfield, Whitstable、イギリス
- 1264.3.44027 Boehringer Ingelheim Investigational Site
-
Chippenham、イギリス
- 1264.3.44011 Boehringer Ingelheim Investigational Site
-
Johnstone、イギリス
- 1264.3.44033 Boehringer Ingelheim Investigational Site
-
Midsomer Norton、イギリス
- 1264.3.44007 Boehringer Ingelheim Investigational Site
-
Paisley、イギリス
- 1264.3.44034 Boehringer Ingelheim Investigational Site
-
Warminster、イギリス
- 1264.3.44031 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Harju、エストニア
- 1264.3.37207 Boehringer Ingelheim Investigational Site
-
Pärnu、エストニア
- 1264.3.37209 Boehringer Ingelheim Investigational Site
-
Tallin、エストニア
- 1264.3.37203 Boehringer Ingelheim Investigational Site
-
Tallin、エストニア
- 1264.3.37204 Boehringer Ingelheim Investigational Site
-
Tallin、エストニア
- 1264.3.37205 Boehringer Ingelheim Investigational Site
-
Tallinn、エストニア
- 1264.3.37201 Boehringer Ingelheim Investigational Site
-
Tallinn、エストニア
- 1264.3.37202 Boehringer Ingelheim Investigational Site
-
Tallinn、エストニア
- 1264.3.37208 Boehringer Ingelheim Investigational Site
-
Tartu、エストニア
- 1264.3.37206 Boehringer Ingelheim Investigational Site
-
Viljandi County、エストニア
- 1264.3.37210 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Badía del Vallès - Barcelona、スペイン
- 1264.3.34013 Boehringer Ingelheim Investigational Site
-
Barcelona、スペイン
- 1264.3.34001 Boehringer Ingelheim Investigational Site
-
Barcelona、スペイン
- 1264.3.34008 Boehringer Ingelheim Investigational Site
-
Borges del Camp- Tarragona、スペイン
- 1264.3.34005 Boehringer Ingelheim Investigational Site
-
Canet de Mar - Barcelona、スペイン
- 1264.3.34006 Boehringer Ingelheim Investigational Site
-
Centelles - Barcelona、スペイン
- 1264.3.34010 Boehringer Ingelheim Investigational Site
-
L'Hospitalet de Llobregat、スペイン
- 1264.3.34009 Boehringer Ingelheim Investigational Site
-
L'Hospitalet de Llobregat - Barcelona、スペイン
- 1264.3.34004 Boehringer Ingelheim Investigational Site
-
Sant Adrià del Besós- Barcelona、スペイン
- 1264.3.34002 Boehringer Ingelheim Investigational Site
-
Tarrega - Lleida、スペイン
- 1264.3.34007 Boehringer Ingelheim Investigational Site
-
Valencia、スペイン
- 1264.3.34012 Boehringer Ingelheim Investigational Site
-
Vic - Barcelona、スペイン
- 1264.3.34011 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Bad Lauterberg / Harz、ドイツ
- 1264.3.49001 Boehringer Ingelheim Investigational Site
-
Dietzenbach、ドイツ
- 1264.3.49007 Boehringer Ingelheim Investigational Site
-
Dortmund、ドイツ
- 1264.3.49002 Boehringer Ingelheim Investigational Site
-
Essen、ドイツ
- 1264.3.49009 Boehringer Ingelheim Investigational Site
-
Hamburg、ドイツ
- 1264.3.49003 Boehringer Ingelheim Investigational Site
-
Ingelheim、ドイツ
- 1264.3.49012 Boehringer Ingelheim Investigational Site
-
Leipzig、ドイツ
- 1264.3.49008 Boehringer Ingelheim Investigational Site
-
Mainz、ドイツ
- 1264.3.49005 Boehringer Ingelheim Investigational Site
-
Offenbach、ドイツ
- 1264.3.49010 Boehringer Ingelheim Investigational Site
-
Stuhr、ドイツ
- 1264.3.49004 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Daugavpils、ラトビア
- 1264.3.37105 Boehringer Ingelheim Investigational Site
-
Daugavpils、ラトビア
- 1264.3.37112 Boehringer Ingelheim Investigational Site
-
Daugavpils、ラトビア
- 1264.3.37113 Boehringer Ingelheim Investigational Site
-
Jelgava、ラトビア
- 1264.3.37110 Boehringer Ingelheim Investigational Site
-
Liepaja、ラトビア
- 1264.3.37101 Boehringer Ingelheim Investigational Site
-
Ogre、ラトビア
- 1264.3.37106 Boehringer Ingelheim Investigational Site
-
Riga、ラトビア
- 1264.3.37104 Boehringer Ingelheim Investigational Site
-
Riga、ラトビア
- 1264.3.37108 Boehringer Ingelheim Investigational Site
-
Riga、ラトビア
- 1264.3.37109 Boehringer Ingelheim Investigational Site
-
Riga、ラトビア
- 1264.3.37111 Boehringer Ingelheim Investigational Site
-
Talsi、ラトビア
- 1264.3.37107 Boehringer Ingelheim Investigational Site
-
Tukums、ラトビア
- 1264.3.37102 Boehringer Ingelheim Investigational Site
-
Valmiera、ラトビア
- 1264.3.37103 Boehringer Ingelheim Investigational Site
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria:
- Diagnosis of type 2 diabetes mellitus prior to informed consent
- Male and female patients with insufficient glycaemic control (HbA1c >= 7.0 to <= 10.5% at Visit 2) on diet and exercise alone, without oral antidiabetic drug therapy within 10 weeks prior to start of the run-in period (date of Visit 2)
- Age >= 18 and <= 80 years at start date of Visit 1 (Screening)
- BMI <= 45 kg/m2 (Body Mass Index) at start date of Visit 1 (Screening)
- Signed and dated written informed consent by start date of Visit 1 in accordance with GCP and local legislation
Exclusion criteria:
- Uncontrolled hyperglycaemia with a confirmed glucose level > 240 mg/dl (> 13.3 mmol/l) after an overnight fast during screening or placebo run-in period (cf. Section 3.3.4.1)
- Myocardial infarction within 6 months, stroke or TIA within 3 months prior to informed consent
- Clinical evidence of active liver disease (e.g. jaundice) or the ALT level > 2.5 times the upper limit of normal (according to pioglitazone label)
- Bariatric surgery, performed within the past 2 years prior to informed consent or planned at the time of informed consent
- Gastrointestinal surgeries prior to informed consent that induce chronic malabsorption
- Known hypersensitivity or allergy to the investigational products (linagliptin and/or pioglitazone) or their excipients (including matching placebos)
Contraindications to pioglitazone as defined in the local prescribing information (SPC), particularly :
- Diagnose of heart failure or history of heart failure
- Haemodialysis patients, due to limited experience with pioglitazone
- Treatment with gemfibrozil, montelukast, trimethoprim, or rifampicin - according to pioglitazone label and respective restrictions in Section 4.2.2
- Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, or insulin within 3 months prior to informed consent
- Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent
- Alcohol or drug abuse within the 3 months prior to informed consent or history of alcoholism
- Current treatment with systemic corticosteroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
- Participation in another trial with an investigational drug within 30 days prior to informed consent
- Any other clinical condition as judged by the investigator that would not allow the safe completion of the protocol, e.g. inability of patients to comply with study procedures
Pre-menopausal women (last menstruation <= 1 year prior to informed consent) who:
- are nursing or pregnant or
- are of child-bearing potential (i.e. not permanently sterilised) and are not practicing a highly effective method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
A highly effective method of birth control is defined - according to the Note for Guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) - as those which result in a low failure rate (i. e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices/systems (IUDs/IUSs), sexual abstinence or vasectomised partner
- Symptomatic gallbladder disease in the last six months
- Medical history of pancreatitis.
- Patients with urinary bladder cancer or a history of urinary bladder cancer or uninvestigated macroscopic haematuria
- Any other contraindication or restriction for use of pioglitazone in accordance with the local prescribing information for pioglitazone.
研究計画
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 |
---|---|
アクティブコンパレータ:Pioglitazone 15 mg
Pioglitazone Capsules 15 mg once daily
|
Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks
|
アクティブコンパレータ:Pioglitazone 30 mg
Pioglitazone Capsules 30 mg once daily
|
Pioglitazone Capsules 30 mg once daily for up to 84 weeks
|
アクティブコンパレータ:Pioglitazone 45 mg
Pioglitazone Capsules 45 mg once daily
|
Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks
|
アクティブコンパレータ:Linagliptin 5mg
Linagliptin 5mg Tablets once daily
|
Linagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
|
実験的:Linagliptin 5mg / Pioglitazone 15 mg
Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily
|
Linagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
|
実験的:Linagliptin 5mg / Pioglitazone 30 mg
Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily
|
Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks
|
実験的:Linagliptin 5mg / Pioglitazone 45 mg
Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily
|
Linagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks
|
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 |
---|---|---|
Change From Baseline in HbA1c After 30 Weeks of Treatment.
時間枠:Baseline and 30 weeks
|
HbA1c is measured as a percentage.
The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.
|
Baseline and 30 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment
時間枠:Baseline and 30 weeks
|
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
|
Baseline and 30 weeks
|
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment
時間枠:Baseline and 30 weeks
|
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
|
Baseline and 30 weeks
|
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)
時間枠:Baseline and 30 weeks
|
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
|
Baseline and 30 weeks
|
HbA1c Change From Baseline by Visit Over Time
時間枠:Baseline, week 6, week 12, week 18, week 24, week 30
|
HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment. by visit interaction. |
Baseline, week 6, week 12, week 18, week 24, week 30
|
Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment
時間枠:Baseline and 30 weeks
|
The change from baseline is the FPG after 30 weeks minus the baseline FPG.
|
Baseline and 30 weeks
|
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
時間枠:Baseline, week 6, week 12, week 18, week 24, week 30
|
The change from baseline is the FPG over time minus the baseline FPG.
Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction
|
Baseline, week 6, week 12, week 18, week 24, week 30
|
Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)
時間枠:Baseline and 30 weeks
|
The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.
|
Baseline and 30 weeks
|
Time to First Use of Rescue Therapy
時間枠:30 weeks
|
Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.
|
30 weeks
|
Incidence of Rescue Therapy During the First 30 Weeks of Treatment
時間枠:30 weeks
|
Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.
|
30 weeks
|
協力者と研究者
スポンサー
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
2型糖尿病の臨床試験
Pioglitazone 15 mgの臨床試験
-
Intergroupe Francophone de Cancerologie Thoracique募集
-
Regeneron Pharmaceuticals完了
-
National Cancer Center, JapanOno Pharmaceutical Co. Ltd募集
-
Merck Sharp & Dohme LLC完了慢性咳嗽カナダ, チェコ, デンマーク, ハンガリー, ペルー, ポーランド, ウクライナ, イギリス, アメリカ, オーストラリア, 中国, コロンビア, ドイツ, グアテマラ, イスラエル, イタリア, マレーシア, ニュージーランド, 南アフリカ, 七面鳥
-
Pfizer完了
-
N-Gene Research Laboratories, Inc.Thermo Fisher Scientific, Inc; Integrium; Msource Medical Development GmbH; Kinexum LLC; Haupt Pharma... と他の協力者終了しました