Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases (MAG1C)
Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases: A Randomised, Placebo-controlled Trial
Patients with type 1 diabetes (T1D) depend on insulin therapy as substitution for the lack of endocrine insulin production due to an autoimmune destruction of beta-cells in the pancreatic inslets. Insulin therapy is based on long lasting basal insulin for controlling fasting plasma glucose, and short lasting mealtime insulin for the postprandial plasma glucose. The long term efficacy of this treatment is measured in glycated haemoglobin A1c (HbA1c) of <7.0% as the treatment goal.
Intensive insulin therapy is associated with side effects such as hypoglycaemia, weight gain, and unwanted exaggerated excursions in PPG. This may ultimately affect treatment compliance.
The abovementioned problems associated with insulin treatment in T1D can also be seen in insulin-treated patients with type 2 diabetes (T2D). However, in T2D the combination of insulin with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) has proven effective in reducing the weight gain and insulin dose in insulin-treated patients with T2D without exacerbating the risk of hypoglycaemia.
Exenatid is a short lasting GLP-1RA approved for treatment in T2D, and the investigators intend to evaluate it in a randomized, controlled trial as add-on therapy to standard insulin therapy for patients with T1D.
The investigators hypothesise that the add-on of exenatide to insulin therapy in patients with T1D will reduce insulin requirements, glycaemic excursions and body weight and improve glycaemic control without increasing the risk of hypoglycaemia.
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Capital Region
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Gentofte, Capital Region, 덴마크, 2820
- Steno Diabetes Center Copenhagen
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- T1D according to WHO criteria with duration of ≥1 year
- Age ≥18 years
- BMI >22.0 kg/m2
- HbA1c >7.5% and <10.0% at visit 0 (screening)
- Able to count carbohydrates
Exclusion Criteria:
- Insulin pump treatment
- Hypoglycaemia unawareness (inability to register low blood glucose)
- Diabetic gastroparesis
- Compromised kidney function (eGFR <60 ml/min/1.73m2, dialysis or kidney transplantation)
- Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
- History of acute and/or chronic pancreatitis
- Subjects with personal or family history of medullary carcinoma or MEN syndrome
- Inflammatory bowel disease
- Cancer unless in complete remission for >5 years
- Proliferative retinopathy
- Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
- Alcohol/drug abuse
- Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
- Pregnant or nursing women
- Known or suspected hypersensitivity to trial product or related products
- Receipt of an investigational drug within 30 days prior to visit 0
- Simultaneous participation in any other clinical intervention trial
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention
Exenatide 10 mikrogram, thrice daily, subcutaneous injection prior to main meals, 6 months.
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다른 이름들:
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위약 비교기: Placebo
Placebo, thrice daily, subcutaneous injection prior to main meals, 6 months.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in HbA1c
기간: 6 months
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Change in HbA1c from baseline to end of study (time 6 months)
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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adverse events (including hypoglycaemic episodes)
기간: 6 months
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6 months
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changes in insulin dosage
기간: 6 months
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6 months
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changes in body weight
기간: 6 months
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6 months
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changes in BMI
기간: 6 months
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6 months
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changes in body composition
기간: 6 months
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DXA scan measuring bonemineral density
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6 months
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changes in body composition
기간: 6 months
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DXA scan measuring lean mass
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6 months
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changes in body composition
기간: 6 months
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DXA scan measuring fat mass
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6 months
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changes in fasting plasma glucose
기간: 6 months
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6 months
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changes in post prandial plasma glucose
기간: 6 months
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6 months
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changes in fasting plasma levels of C-peptide
기간: 6 months
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6 months
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Quality of life self reported
기간: 6 months
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Quality of Life Questionaire
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6 months
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Treatment satisfaction
기간: 6 months
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Diabetes treatment satisfactory questionnaire status version
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6 months
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Treatment satisfaction
기간: 6 months
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Diabetes treatment satisfactory questionnaire change version
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6 months
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dietary patterns
기간: 6 months
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Food frequency questionaire three times during the intervention
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6 months
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HDL (High Density Lipoprotein)
기간: 6 months
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6 months
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LDL (Low Density Lipoprotein)
기간: 6 months
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6 months
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VLDL (Very Low Density Lipoprotein)
기간: 6 months
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6 months
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총 콜레스테롤
기간: 6 개월
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6 개월
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triglycerides
기간: 6 months
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6 months
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proBNP (Pro-Brain Natriuretic Peptide)
기간: 6 months
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6 months
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hsCRP (High-Sensitivity C-Reactive Protein)
기간: 6 months
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6 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Johansen NJ, Dejgaard TF, Lund A, Vilsboll T, Andersen HU, Knop FK. Protocol for Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetes Cases (The MAG1C trial): a randomised, double-blinded, placebo-controlled trial. BMJ Open. 2018 Jun 27;8(6):e021861. doi: 10.1136/bmjopen-2018-021861.
- Johansen NJ, Dejgaard TF, Lund A, Schluntz C, Frandsen CS, Forman JL, Wewer Albrechtsen NJ, Holst JJ, Pedersen-Bjergaard U, Madsbad S, Vilsboll T, Andersen HU, Knop FK. Efficacy and safety of meal-time administration of short-acting exenatide for glycaemic control in type 1 diabetes (MAG1C): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2020 Apr;8(4):313-324. doi: 10.1016/S2213-8587(20)30030-9. Epub 2020 Mar 2.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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