CTRI/2024/01/061256尚未招募3 期
Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) s.c. in doses 2.4/2.4 mg and 1.0/1.0 mg once weekly versus semaglutide 2.4 mg and 1.0 mg, cagrilintide 2.4 mg and placebo in participants with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor - REIMAGINE 2
ovo Nordisk AS0 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
- 尚未招募
- 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. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •2. Male or female.
- •3. Age 18 years or above at the time of signing the informed consent.
- •4. Diagnosed with type 2 diabetes mellitus = 180 days before screening.
- •5. Stable daily dose(s) = 90 days before screening of any of the following antidiabetic drug(s) or
- •combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:
- •metformin with or without an SGLT2 inhibitor.
- •6. HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at
- •7. BMI = 25 kg/m2 at screening. BMI will be calculated in the eCRF based on height and body
- •weight at screening.
排除标准
- •1. Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m2 as
- •determined by central laboratory at screening.
- •2. Treatment with any medication for the indication of diabetes or obesity other than stated in the
- •inclusion criteria within 90 days before screening. However, short term insulin treatment for a
- •maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are
- •3. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a
- •fundus examination performed within 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.
- •4. Anticipated initiation or change in concomitant medications (for more than 14 consecutive
- •days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid
- •hormones, or corticosteroids).
- •5. Previous or planned (during the study period) obesity treatment with surgery or a weight loss
- •device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if
- •performed > 1 year before screening, (2) lap banding, if the band has been removed > 1 yearbefore screening, (3) intragastric balloon, if the balloon has been removed > 1 year before
- •screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before
- •6. A self-reported change in body weight > 5% within 90 days before screening irrespective of
- •medical records.
研究者
相似试验
招募中
3 期
REIMAGINE 2: A research study to see how well CagriSema compared to semaglutide, cagrilintide and placebo lowers blood sugar and body weight in people with type 2 diabetes treated with metformin with or without an SGLT2 inhibitorType 2 diabetesJPRN-jRCT2031230369Hiroko Nishida2,700
尚未招募
3 期
A research study to see how much CagriSema lowers blood sugar and body weight compared to tirzepatide in people with type 2 diabetes treated with metformin with or without an SGLT2 inhibitorCTRI/2024/03/064047ovo Nordisk
进行中（未招募）
1 期
REDEFINE 1: A research study to see how well CagriSema helps people losing weight in people who have a body weight above the healthy rangeObesity, OverweightMedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 24.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2020-005435-75-DKovo Nordisk A/S3,400
招募中
1 期
REDEFINE 1: A research study to see how well CagriSema helps people losing weight in people who have a body weight above the healthy rangeObesity, OverweightMedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 24.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2020-005435-75-BGovo Nordisk A/S3,400
进行中（未招募）
1 期
REDEFINE 1: A research study to see how well CagriSema helps people losing weight in people who have a body weight above the healthy rangeObesity, OverweightMedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 24.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2020-005435-75-FRovo Nordisk A/S3,400