NCT04153981已完成4 期
A Multicenter, Open-Label, Single-Arm, Phase 4 Study to Assess the Safety of Basaglar in Subjects With Type 2 Diabetes Mellitus in India
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 11
- 主要终点
- Number or Participants With Hypoglycemic Events
研究概览
简要总结
The reason for this study is to see if insulin glargine is safe in participants with type 2 diabetes mellitus (T2DM) in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have T2DM based on the disease diagnostic criteria from the World Health Organization (WHO) classification for at least 6 months before screening.
- •Have been receiving glucagon-like peptide-1 receptor agonist (GLP-1 RA) or ≥2 oral antihyperglycemic medication (OAMs) at stable doses for 90 days prior to screening.
- •Have an HbA1c level ≥7.0% and <11.0%.
- •Have never been treated with insulins except for short term treatment of acute conditions up to a maximum of 14 days.
排除标准
- •Have any form of diabetes other than T2DM.
- •Have hypersensitivity to the active substance of LY2963016 or to any of the excipients.
- •Have any clinically significant disorder, other than T2DM, that in the investigator's opinion, would preclude participation in the trial.
- •Are receiving systemic glucocorticosteroids therapy or have excessive insulin resistance (total insulin dose >2 units per kilogram).
- •Have a history or diagnosis of human immunodeficiency virus infection, hepatitis B and C.
- •Have comorbidities of unstable angina, cardiac failure (Stage III or IV as per New York Heart Association guidelines) or renal failure (estimated glomerular filtration rate <30 milliliters/minute/meter squared).
- •Are pregnant or intend to become pregnant during the course of the study; or are sexually active women of child-bearing potential not actively practicing birth control by a medically acceptable method as determined by the investigator.
- •Is a woman who is breastfeeding.
- •Have participated within the last 30 days in a clinical trial involving an investigational product other than the LY
- •If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed.
- •Have previously completed or withdrawn from this study or any other study investigating LY
- •This exclusion criterion does not apply to participants who are rescreened prior to baseline visit.
- •Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Are unwilling or unable to comply with the use of a glucometer.
研究组 & 干预措施
Insulin Glargine
Experimental
Participants received insulin glargine once a day (QD) subcutaneously (SC) with a starting dose of 10 units. Participants self-titrated once or twice weekly until fasting blood glucose level was lowered to <100 milligrams per deciliter (mg/dL). Dose was reduced by 4 units in case of hypoglycemia.
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Number or Participants With Hypoglycemic Events
时间窗: Baseline to Week 24
Hypoglycemic event is when the fasting blood glucose (FBG) level is ≤ 54 milligrams per deciliter (mg/dL) \[≤ 3.0 millimoles per liter (mmol/L)\].
次要结局
- Change From Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ)(Baseline (Week 4), Week 24)
- Basal Insulin Dose(Week 24)
- Change From Baseline in Body Weight(Baseline, Week 24)
- Change From Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 12 and Week 24)
- Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values(Baseline, Week 24)
研究者
研究点 (11)
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