The use of glycaemic response to sulphonylureas as a tool to investigate Type 2 diabetes pathophysiology - Variation in sulphonylurea response in Type 2 diabetes

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000594-29-GB

Enrollment

Unknown

Registered

2007-02-26

Start date

2007-04-25

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Interventions

Trade Name: Gliclazide Pharmaceutical Form: Tablet INN or Proposed INN: GLICLAZIDE CAS Number: 21187984 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Study 1. • Type 2 diabetes • Age >35 and 35 and 60mls/min • No frank proteinuria (on multistix 10SG) • No active foot ulceration or infection • Liver ALT within the laboratory reference range • Contactable by telephone Study 2. • Age >35 and 35 and 60 ml/min • No frank proteinuria (on multistix 10SG) • No active foot ulceration or infection • Liver ALT within the laboratory reference range • Contactable by telephone 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Type 1 diabetes • HbA1c >10% prior to commencing SU • HbA1c>9% on SU treatment Study 1 • Previous cardiovascular or cerebrovascular disease • Pre-proliferative or proliferative retinopathy • eGFR<60 ml/min • Proteinuria (multistix 10 SG) • Active foot ulceration or infection • Liver ALT outwith the reference range • Female planning to conceive within the study period • Any other significant medical reason for exclusion as determined by the investigator Study 2 • Type 1 diabetes • HbA1c = 7% or = 9%. • Previous cardiovascular or cerebrovascular disease • Pre-proliferative or proliferative retinopathy • eGFR< 60 ml/min • Proteinuria (multistix 10 SG) • Active foot ulceration or infection • Liver ALT outwith the reference range • Female planning to conceive within the study period • Any other significant medical reason for exclusion as determined by the investigator

Design outcomes

Primary

Measure	Time frame
Main Objective: To define phenotypic differences that predict sulphonylurea response in order to identify aetiological differences in these distinct subgroups, by intensively studying: i. Beta cell response to intravenous glucose and tolbutamide to identify quantitative and qualitative differences in function ii. Insulin sensitivity iii. Pharmacokinetics ;Secondary Objective: a) To establish a cohort of patients who are adherent to sulphonylurea therapy, but whose response is either good or poor. b) To validate the initial determination of response from the database by correlation with a controlled re-challenge response, to allow future large-scale pharmacogenetics studies c) To investigate whether patients GG homozygous at rs12255372 of TCF7L2 respond better to sulphonylureas than those who are TT homozygous at this SNP ;Primary end point(s): Study 1 and 2. Change in HbA1c	—

Measure

Time frame

Main Objective: To define phenotypic differences that predict sulphonylurea response in order to identify aetiological differences in these distinct subgroups, by intensively studying: i. Beta cell response to intravenous glucose and tolbutamide to identify quantitative and qualitative differences in function ii. Insulin sensitivity iii. Pharmacokinetics ;Secondary Objective: a) To establish a cohort of patients who are adherent to sulphonylurea therapy, but whose response is either good or poor. b) To validate the initial determination of response from the database by correlation with a controlled re-challenge response, to allow future large-scale pharmacogenetics studies c) To investigate whether patients GG homozygous at rs12255372 of TCF7L2 respond better to sulphonylureas than those who are TT homozygous at this SNP ;Primary end point(s): Study 1 and 2. Change in HbA1c

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026