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治験 NCT00609895（対象：糖尿病）は完了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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サノフィThe Incidence of Hypoglycemia in Insulin Glargine-Treated Subjects With Diabetes Mellitus Upon Switching Between Bedtime and Morning Dosing 第IV相・フェーズ4 22
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT00609895 は 治療 の研究で、糖尿病 を対象とした 第IV相・フェーズ4 介入研究 臨床試験 でした。現在は 完了 です。2004年1月1日 に開始し、22 名の参加者 が参加しました。この試験は サノフィ によって主導され、2004年8月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2008年3月28日 です。
概要
To compare the percentage of subjects with a glucose measurement < than or = to 56 mg/dL at any point of the 8-point glucose profiles during 3 consecutive days before vs. 3 consecutive days after switching insulin glargine dosing time from bedtime to morning and vs. 3 consecutive days after switching back to bedtime dosing of insulin glargine.
公式タイトル
The Incidence of Hypoglycemia in Insulin Glargine-Treated Subjects With Diabetes Mellitus Upon Switching Between Bedtime and Morning Dosing
疾患名
糖尿病その他の研究識別子
- HOE901_4038
主目的
治療
割付方法
非無作為化
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
該当なし | INSULIN GLARGINE |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Compare % of subjects with glucose > or = to 56 mg/dL at any point of 8-point glucose profiles during 3 consecutive days | before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Compare % subjects with glucose measurements < or = to 72 mg/dL & < or = to 36 mg/dL at any point of the 8-point glucose profile during 3 consecutive days | before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime | |
To compare the mean daily rate of hypoglycemia during 3 consecutive days | before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime | |
To compare the changes from baseline in glucose values at each specific measurement time of the 8-point glucose profile during 3 consecutive days | before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime | |
To compare the incidence of symptomatic hypoglycemia | at any time during 3 consecutive days before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime | |
To evaluate overall safety and tolerability based on adverse event reporting, laboratory tests, and clinical examinations | at any time during the study |
適格基準
対象年齢
小児, 成人, 高齢者
試験の最低年齢
6 Years
対象性別
全て
- Type 1 or type 2 diabetes mellitus diagnosis for at least 1 year Administration of insulin glargine for at least 2 months prior to screening; subjects must be on a stable dose of insulin glargine, + or - 15%, for at least 1 week prior to screening, given once daily at bedtime, and the dose must remain unchanged (+ or - 15%) during the screening period.
- If subjects are taking a short-acting insulin (e.g., regular human insulin, insulin lispro, or insulin aspart) or oral antidiabetic agents (e.g., a sulfonylurea, metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, or a metiglinide), the subject must have been receiving these medications for at least 2 months prior to screening.
- For subjects taking an oral antidiabetic agent, the dose must be unchanged for the 2 weeks (4 weeks for a thiazolidinedione) prior to screening and should not be expected to be changed from the screening visit (day 14) through the final visit (day 11). The dose of any short-acting insulin may be changed if medically indicated.
- Males or non-pregnant females between the ages of 6 and 75 years; women must be postmenopausal for more than 2 years, surgically sterile, or agree to use a reliable contraceptive measure for the duration of the study. Reliable contraceptive measures include the following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide.
- Ability and willingness to perform blood glucose profiles using a plasma glucose meter provided at home over 11 consecutive days.
- HbA1c < than or = to 8.5% at screening.
- Use of any other intermediate- or long-acting insulin (e.g., NPH, Ultralenter, Lenter) within the last 2 months prior to screening.
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g., systemic corticosteroids).
- History of hypoglycemia unawareness.
- Pregnancy (as determined by a serum pregnancy test at the screening visit).
- Breast-feeding.
- Treatment with any investigational drug in the 2 months prior to the screening visit.
- Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult.
- History of drug or alcohol abuse.
- Impaired hepatic function, as shown by but not limited to serum glutamic-oxaloacetic transaminase (SGPT, also known as alanine transaminase \[ALT\]) or serum glutamic-pyruvic transaminase (SGOT, also known as aspartate transaminase \[AST\]) above 2x the upper limit of normal range (ULN) measured at the screening visit.
- Impaired renal function, as shown by, but not limited to serum creatinine > than or = to 1.5 mg/dL (133 micromol/L) \[males\] or > than or = to1.4 mg/dL (124 micromol/L) \[females\] measured at the screening visit. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
- Subjects who work the night shift.
サノフィ