Glimepiride monotherapy vs. combination of glimepiride and linagliptin therapy in patients with maturity onset diabetes of the young type 3 (MODY3)

Phase 1

• Conditions: Hepatocyte nuclear factor 1-alfa diabetes, also called Maturity onset diabetes of the young type 3'. It is a monogenic form of inherited diabetes.; MedDRA version: 20.0Level: LLTClassification code 10026948Term: Maturity-onset diabetes of the youngSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-000204-15-DK
• Lead Sponsor: Professor, DMSc Tina Vilsbøll

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-22
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with hepatocyte nuclear factor 1-alpha (HNF1A) diabetes caused by heterozygous mutation in HNF1A confirmed by Sanger sequencing of the gene
• Monotherapy with diet or a stable dose of glimepiride of (=0.5 mg per day) during four weeks
• Patients on glimepiride HbA1c =6.5% (HbA1c =47 mmol/mol); treatment naïve patients HbA1c =7.0% (HbA1c =53 mmol/mol)
• Age =18 years of age
• Capability to perform a 30 minute light bicycle test at a heart rate of 100-120 beats per min
• Fertile females: use of anticonception (intrauterine contraceptive devices or hormonal contraception)
• 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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

• Glucose-lowering drugs other than glimepiride
• Uraemia, end-stage renal disease or estimated glomerular filtration rate <30 ml/min/1.73m2 and/or albuminuria
• Liver disease and/or alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) >2 × upper normal serum levels
• Anaemia (males blood haemoglobin <8.0 mmol/l and females <7.0 mmol/l)
• History of acute and/or chronic pancreatitis
• Pregnancy or breast feeding
• Inability to complete the study
• Known allergic reaction to study medication
• Intention to become pregnant

Study & Design

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