CTRI/2024/02/062375招募中3 期
A 40-week study comparing the efficacy and safety of once weekly IcoSema and daily insulin glargine 100 units/mL in participants with type 2 diabetes inadequately controlled on oral anti-diabetic drugs. - COMBINE 4
ovo Nordisk0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female and age above or equal to 18 years at the time of signing the informed consent.
- •2. Diagnosed with T2D = 180 days before screening.
- •3. HbA1c = 8.0% (= 64.0 mmol/mol) as assessed by central laboratory on the day of screening.
- •4. Insulin naïve. Short term insulin treatment for a maximum of 14 consecutive days before screening is allowed, as is prior insulin treatment for gestational diabetes.
- •5. Currently treated with 1-3 OADs with stable daily doses = 90 days before screening comprising any of the following anti-diabetic drug(s) at effective or maximum tolerated dosea:
- •Metformin, Sulfonylureasb, Meglitinides (glinides)b, DPP-4 inhibitorsb, Sodium-glucose co-transporter 2 inhibitors, Alpha-glucosidase-inhibitors, Thiazolidinediones, Marketed oral combination products only including the products listed above.
- •6. Body mass index (BMI) = 40.0 kg/m2.
- •aAs per investigator judgement, participant is suitable for intensification with injectables. bSulfonylureas, meglitinides (glinides) and DPP-4 inhibitors must be discontinued at randomisation.
排除标准
- •1. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- •2. Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids).
- •3. Any episodesa of diabetic ketoacidosis or treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
- •4. Presence or history of pancreatitis (acute or chronic) within 180 days before screening.b
- •5. Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
- •6. Chronic heart failure classified as being in New York Heart Association Class IV at screening.
- •7. Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
- •8. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
- •aas declared by the participant or in the medical records, bFor Turkey, stricter exclusion criteria applies Presence or history of pancreatitis (acute or chronic) ?
- •For Italy, an additional exclusion criteria known severe diabetic autonomic neuropathy as judged by the investigator ? is applicable.
- •Data monitoring committee: No
研究者
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