Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea (JAS)
Efficacy of Adding Sitagliptin or Pioglitazone to Patients With Type 2 Diabetes Insufficiently Controlled With Metformin and Sulfonylurea
調査の概要
詳細な説明
This is a prospective, open-label, randomized, parallel, 24-week study. Inclusion criteria: type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to their half maximally dose (sulfonylureas > half maximal dose, and metformin > 1500 mg/d) for > 10 weeks. > 20 years old; A1C:> 7.0 % and < 11% Exclusion criteria: insulin use within 12 weeks of the screening visit, any contraindications for use of sitagliptin or pioglitazone, impaired renal function (serum creatinine > 1.4 mg/dl), alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) > 2.5 times the upper limit of normal (ULN), current or prepare to pregnancy and lactation.
Primary Purpose:
compare the change in hemoglobin A1c and the proportion of patients achieving A1C < 7% between the 2 groups
Secondary Purposes:
- Changes in fasting plasma glucose, high sensitive C-reactive protein (hsCRP)
- Homeostasis model assessment-β cell function(HOMA-β) will be calculated to assess changes in β-cell function and HOMA-insulin resistance(HOMA-IR)to assess changes in insulin resistance
- Body weight change, proportion of side effects
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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-
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Taipei、台湾、10449
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
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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:
- Type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to their half maximally dose (sulfonylureas > half maximal dose, and metformin > 1500 mg/d) for > 10 weeks
- > 20 years old
- A1C: > 7.0 % and < 11%
Exclusion Criteria:
- Insulin use within 12 weeks of the screening visit
- Any contraindications for use of sitagliptin or pioglitazone, impaired renal function (serum creatinine > 1.4 mg/dl), alanine aminotransferase or aspartate aminotransferase levels > 2.5 times the upper limit of normal
- Current or prepare to pregnancy and lactation
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:なし(オープンラベル)
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:sitagliptin
add sitagliptin100mg/d to pre-study OADs
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add sitagliptin100mg/d to pre-study OADs
他の名前:
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アクティブコンパレータ:pioglitazone
add pioglitazone 30mg/d to pre-study OADs
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add pioglitazone 30mg/d to pre-study OADs
他の名前:
|
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 |
---|---|---|
Mean Change in Glycosylated Hemoglobin (A1C)
時間枠:24 weeks
|
A1C change from baseline to 24 weeks
|
24 weeks
|
Baseline A1C
時間枠:Baseline
|
baseline A1C
|
Baseline
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The Percentages of Patient Achieving an A1C <7%
時間枠:24 weeks
|
The percentages of patient achieving an A1C <7% at endpoint
|
24 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Changes in Fasting Plasma Glucose
時間枠:24 weeks
|
fasting serum sugar change from baseline to 24 weeks
|
24 weeks
|
Changes in High Sensitive C-reactive Protein
時間枠:24 weeks
|
fasting high sensitive serum C-reactive protein change from baseline to 24 weeks
|
24 weeks
|
Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
時間枠:24 weeks
|
HOMA-IR change from baseline to 24 weeks
|
24 weeks
|
Body Weight Change
時間枠:24 weeks
|
body weight change from baseline to 24 weeks
|
24 weeks
|
Percentages of Patients With Total Adverse Events (AE)
時間枠:24 weeks
|
percentages of total adverse events
|
24 weeks
|
Change in Fasting Total-cholesterol
時間枠:24 weeks
|
Total-cholesterol change from baseline to 24 weeks
|
24 weeks
|
Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
時間枠:24 weeks
|
LDL-C change from baseline to 24 weeks
|
24 weeks
|
Change in Fasting Triglycerides(TG)
時間枠:24 weeks
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TG change from baseline to 24 weeks
|
24 weeks
|
Change in Fasting High-density Lipoprotein Cholesterol(HDL-C)
時間枠:24 weeks
|
HDL-C change from baseline to 24 weeks
|
24 weeks
|
Change in Fasting Plasma Alanine-aminotransferase (ALT)
時間枠:24 weeks
|
ALT change from baseline to 24 weeks
|
24 weeks
|
Percentages of Patients With Mild to Moderate Hypoglycemia
時間枠:24 weeks
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Incidence of mild to moderate hypoglycemia after treatment
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24 weeks
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Percentages of Patients With Edema
時間枠:24 weeks
|
proportion of edema after treatment
|
24 weeks
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Percentages of Patients With Gastrointestinal Adverse Events
時間枠:24 weeks
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Proportion of Gastrointestinal adverse events after treatment
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24 weeks
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Percentages of Patients With Nasopharyngitis
時間枠:24 weeks
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Proportion of Nasopharyngitis after treatment
|
24 weeks
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Percentages of Patients With Severe Hypoglycemia
時間枠:24 weeks
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Proportion of severe hypoglycemia after treatment
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24 weeks
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Baseline Fasting Plasma Glucose
時間枠:baseline
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Baseline fasting plasma glucose
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baseline
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Baseline High Sensitive C-reactive Protein
時間枠:baseline
|
Baseline high sensitive C-reactive Protein
|
baseline
|
Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
時間枠:Baseline HOMA-IR
|
Baseline HOMA-IR
|
Baseline HOMA-IR
|
Baseline Alanine-aminotransferase (ALT)
時間枠:Baseline
|
Baseline alanine-aminotransferase
|
Baseline
|
Baseline Body Weight
時間枠:Baseline
|
Baseline body weight
|
Baseline
|
Baseline Total Cholesterol
時間枠:Baseline
|
Baseline Total cholesterol
|
Baseline
|
Baseline Triglyceride (TG)
時間枠:Baseline
|
Baseline TG
|
Baseline
|
Baseline Low-density Lipoprotein Cholesterol (LDL-C)
時間枠:Baseline
|
Baseline LDL-C
|
Baseline
|
Baseline High-density Lipoprotein Cholesterol (HDL-C)
時間枠:Baseline
|
Baseline HDL-C
|
Baseline
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Sung-Chen Liu, MD、Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
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。
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