Trial comparing two diabetes medications (Gliclazide versus Linagliptin) on frequency of low blood sugar levels in patients with Type 2 Diabetes and chronic moderate to severe kidney disease

Phase 4

Completed

• Conditions: UKCRC code/ Disease: Renal and Urogenital/ Other disorders of kidney and ureter, Renal and Urogenital/ Other disorders of kidney and ureter; Urological and Genital Diseases; Specialty: Renal disorders, Primary sub-specialty: Renal disorders; Type 2 Diabetes and moderate to severe chronic kidney disease

• Registration Number: ISRCTN17462005
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-02
• Study Completion: 2018-07-31
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Type 2 Diabetes of 10 years or more duration
2. Age between 50 years and 75 years
3. eGFR 15 to 45 ml/min/1.73m2
4. HbA1c < 65 mmol/mol (< 8%)
5. Taking Gliclazide (with or without Metformin)
6. Stable diabetic control for the last 2 months prior to randomisation
7. Individuals who understand adequate written and verbal English

Exclusion Criteria

1. Type 1 Diabetes
2. Currently on insulin, pioglitazone, other dipeptidylpeptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists
3. Immunosuppressive therapy (excluding inhaled steroids) within the previous 6 months
4. Pregnant or lactating women
5. Malignancy or other life threatening illness
6. Inability to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall glycaemic control and percent of time spent in hypoglycaemia will be assessed using data captured on the Medtronic iPro2 Continuous Glucose Monitor over a two 7 day periods (a minimum of continuous 48 hours of CGM monitoring) and home capillary blood glucose monitoring at Visit 1 (baseline, before randomisation) and Visit 4 (7 weeks after randomisation).

Secondary Outcome Measures

Name	Time	Method
<br> 1. Serum and Urinary markers of inflammation and fibrosis will be analysed by measuring urinary albumin excretion and serum and urinary MCP-1 and TGF-beta 1 at Visit 2 (randomisation visit, 1 week after baseline visit) and Visit 5 (final study visit, 8 weeks after randomisation)<br> 2. Treatment satisfaction will be measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Visit 2 (randomisation visit, 1 week after baseline visit) and Visit 5 (final study visit, 8 weeks after randomisation)<br>