Personalized treatment of type 2 diabetes

Phase 1

• Conditions: Type 2 diabetes; MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2020-000913-33-SE
• Lead Sponsor: niversity of gothenburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-17
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

•Diabetes mellitus diagnosed according to the WHO criteria and disease characteristics typical for SIDD or SIRD according to the ANDIS clustering
•Ongoing metformin therapy with constant dose the last three months
•Age 18 years or above
•HbA1c =48 and <91 mmol/mol
•Women who are not postmenopausal and who have not undergone surgical sterilization must have no current pregnancy, which will be assessed by pregnancy test, must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose and must be willing to use a method of contraception that is reliable in the judgement of the Investigator
•Willingness to take injectable and oral medication
•Written informed consent
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

•Type 1 diabetes, LADA, MODY, secondary diabetes or history of diabetic ketoacidosis
•Anti-diabetic treatment other than metformin within 90 days prior to randomization or changed metformin dose within 90 days prior to randomization
•Known acute cardiovascular event, e.g. transient ischemic attack, stroke, acute coronary syndrome, decompensated heart failure, coronary by-pass surgery or other coronary vessel intervention within 90 days prior to screening.
•Heart failure NYHA class IV
•History of acute or chronic pancreatitis
•Known liver cirrhosis
•A level of aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT), ALP or bilirubin of more than three times the upper limit of the normal range
•Current chronic daily treatment with an oral steroid at a dose equivalent to oral prednisolone =10 mg (e.g., betamethasone =1.2 mg, dexamethasone =1.5 mg, hydrocortisone =40 mg)
•Pregnancy or breast-feeding
•Known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
•Estimated glomerular filtration rate <45 ml/min/1,73 m2 or unstable or rapidly progressing renal disease
•Participant unable to understand the study information herself or himself
•Involvement in the planning and/or conduct of the study
•Participation in other clinical trial which may affect the outcome of the present study
•Any condition or treatment that in the judgment of the investigator makes it difficult or unsafe to participate in the study.

Study & Design

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