To compare gliclazide with linagliptin on the frequency of hypoglycaemia among patients with type II diabetes and chronic kidney disease stage 3b and 4.

A randomised controlled trial of the sulfonylurea Gliclazide and the DPP4 inhibitor Linagliptin on the frequency of hypoglycaemia among patients with Type 2 Diabetes and chronic kidney disease (CKD) stage 3b and 4. - GLOOCOSE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002309-12-GB

Enrollment

Registered

2016-03-21

Start date

2015-11-30

Completion date

Unknown

Last updated

2020-02-01

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

Conditions

Diabetes Mellitus and chronic kidney disease

Interventions

Trade Name: Linagliptin Product Name: Linagliptin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Linagliptin CAS Number: 6

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. T2DM of 10 years or more duration 2. Age between 50 yrs and 75 yrs 3. eGFR 15 to 45ml/min/1.73m2 4. HbA1c =65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: 1. T1DM 2. Currently on insulin, pioglitazone, other dipeptidylpeptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists 3. Immunosuppressive therapy within the previous year 4. Pregnant or lactating women 5. Malignancy or other life threatening illness 6. Inability to give informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether a patient with type 2 diabetes and moderate to severe kidney disease suffers from hypoglycaemia, less when taking Linagliptin, in place of the UK's most commonly used oral hypoglycaemic agent, Gliclazide.; Secondary Objective: The study will assess whether Linagliptin has any other advantages over Gliclazide by looking at markers in the blood and urine that are associated with deteriorating kidney function. The study will also assess whether participants feel better when on either Linagliptin or Gliclazide. ; Primary end point(s): The per cent of time spent in hypoglycaemia (defined as CGM tissue glucose less than or equal to 3.9mmol/L), before and after randomisation to either continuation of standard Gliclazide therapy or 5mg Linagliptin (with or without their pre randomised dose of metformin). The overall glycaemic control, including: glucose variability, Mean Amplitude of Glycaemic Excursions (MAGE) SD around the mean sensor glucose, Mean Of Daily Differences (MODD), fasting and mean sensor glucose, the per cent of time spent in hyperglycaemia (defined as CGM tissue glucose above or equal to 15 mmol/L),the High Glucose Index (HBGI) and the Low Blood Glucose Index (LBGI). Home blood glucose monitoring of fasting blood glucose before and after randomisation to either continuation of standard Gliclazide therapy or 5mg Linagliptin (with or without their pre randomised dose of metformin).	—

Measure

Time frame

Main Objective: To assess whether a patient with type 2 diabetes and moderate to severe kidney disease suffers from hypoglycaemia, less when taking Linagliptin, in place of the UK's most commonly used oral hypoglycaemic agent, Gliclazide.; Secondary Objective: The study will assess whether Linagliptin has any other advantages over Gliclazide by looking at markers in the blood and urine that are associated with deteriorating kidney function. The study will also assess whether participants feel better when on either Linagliptin or Gliclazide. ; Primary end point(s): The per cent of time spent in hypoglycaemia (defined as CGM tissue glucose less than or equal to 3.9mmol/L), before and after randomisation to either continuation of standard Gliclazide therapy or 5mg Linagliptin (with or without their pre randomised dose of metformin). The overall glycaemic control, including: glucose variability, Mean Amplitude of Glycaemic Excursions (MAGE) SD around the mean sensor glucose, Mean Of Daily Differences (MODD), fasting and mean sensor glucose, the per cent of time spent in hyperglycaemia (defined as CGM tissue glucose above or equal to 15 mmol/L),the High Glucose Index (HBGI) and the Low Blood Glucose Index (LBGI). Home blood glucose monitoring of fasting blood glucose before and after randomisation to either continuation of standard Gliclazide therapy or 5mg Linagliptin (with or without their pre randomised dose of metformin).

—

Secondary

Measure	Time frame
Secondary end point(s): The urinary markers of inflammation and fibrosis will be analysed as follows. The urinary albumin excretion and urinary MCP-1 and TGF-beta 1 before and after 8 weeks randomisation to either continuation of their standard therapy or 5mg Linagliptin (with or without their pre randomised dose of metformin). The DTSQ questionnaire will be analysed by the comparisons of the scores before and after randomisation to either continuation of their standard therapy or 5mg Linagliptin (with or without their pre randomised dose of metformin).	—

Measure

Time frame

Secondary end point(s): The urinary markers of inflammation and fibrosis will be analysed as follows. The urinary albumin excretion and urinary MCP-1 and TGF-beta 1 before and after 8 weeks randomisation to either continuation of their standard therapy or 5mg Linagliptin (with or without their pre randomised dose of metformin). The DTSQ questionnaire will be analysed by the comparisons of the scores before and after randomisation to either continuation of their standard therapy or 5mg Linagliptin (with or without their pre randomised dose of metformin).

—

Countries

United Kingdom

Contacts

Public ContactBecky Ward

Imperial College London, Joint Research Compliance Office (JCTO)

jrco@imperial.ac.uk020 7594 1188

Outcome results

None listed

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