Optimal treatment of glucocorticoid-induced diabetes.

Phase 1

• Conditions: Diabetes Mellitus that is induced by the use of glucocorticoids; MedDRA version: 20.0Level: LLTClassification code 10012628Term: Diabetes steroid-inducedSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2018-002640-82-DK
• Lead Sponsor: ordsjællands Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-13
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1.Written signed informed consent prior to any study specific procedures
2.Recent (within a week) diagnosis of GIDM (defined as non-fasting plasma glucose measured > 11.1 mmol/l at two different occasions, OR at one occasion above 11.1 mmol/L with classical hyperglycaemia symptoms, OR a fasting plasma glucose of >7 mmol/L).
3.Hospitalized at the time of screening.
4.Patients >18 years at the time of consent.
5.eGFR = 60 ml/min/1.73 m2 (estimated by CKD-EPI formula) at visit 1
6.Female patients must use contraception. The following contraceptives are considered as safe contraception in drug trials: Intra-uterine-device or hormonal contraception (birth control pills, implant, transdermal patch, vaginal ring or depot injection). Sterile or non-fertile subjects are exempted from the requirement for contraception. In order to be considered sterile or non-fertile, one must generally be surgically sterilized (bilateral oophorectomy or hysterectomised at least six months prior to screening) or be postmenopausal, defined as non-menstrual period for at least 12 months before studying. For some individuals or special populations, there may be relationships that speak against the use of the above methods. Examples may be severely impaired hospitalized patients. Such an assessment is taken by the investigator and is his responsibility
7.Must be able to communicate with the study personnel.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37

Exclusion Criteria

Exclusion criteria
1.Known diabetes (treated or not treated) prior to initiation of glucocorticoid treatment.
2.Use of any blood glucose-lowering medication for the last 30 days prior to the trial for any reason, except up to 2 doses of insulin prior to screening
3.Hyperglycaemia with a glucose level >20mmol/L
4.Any former or ongoing pancreatic disorder.
5.Known or suspected hypersensitivity to trial product(s) or products with the same content/known cross-reactivity.
6.Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods.
7.The receipt of any investigational product 30 days prior to this trial
8.Known or suspected abuse of alcohol or drugs.
9.Suspected non-compliance with the protocol (as judged by the investigator).
10.Involvement in the planning/or conduct of the study
11.Previous randomisation in the study
12.Participation in another study with an investigational product during the last 30 days prior to enrolment
13. Age > 85 years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified