The effect of canagliflozin 300mg on glucose levels in people without diabetes after weight loss surgery.

The effect of Canagliflozin 300mg, in subjects without diabetes after bariatric surgery, on glucose homeostasis (The CONTROL Study): A proof-of-concept, randomised, open-label, two period crossover study. - The CONTROL Study

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004041-32-GB

Enrollment

Registered

2020-07-13

Start date

2020-06-01

Completion date

Unknown

Last updated

2020-07-20

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

Conditions

Postprandial hypoglycaemia after bariatric surgery

Interventions

Trade Name: Invokana Product Name: Invokana Product Code: Not applicable Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Canagliflozin CAS Number: 842133-18-0 Other descriptive name: Invo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age=18 years old but less than 75 years old • Subjects =1 year after gastric bypass (RYGB) or sleeve gastrectomy (SG) • Able to understand written and spoken English • Able to give informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: • Use of any glucose-lowering medication (including insulin) • Adrenal insufficiency and/or substitution with glucocorticoids • ALT >1.5 times the upper normal limit • Moderate to severe renal impairment (eGFR=60 ml/min/1.73m2) • Individuals on loop diuretics • Participants with established diagnosis of postural hypotension by their GP • Recent active infection (over the last 10 days) • Current use of steroids • Other bariatric procedure except of RYGB/SG • Previous revisional bariatric surgery • Currently pregnant or breastfeeding • Females of child-bearing age, unwilling to use contraception during the period of the study • Patients with history of Type 1 or Type 2 diabetes • Intolerant to the Mixed Meal Tolerance test. • HbA1C = 6.5% or =48mmol/l at screening blood tests • Haemoglobin (Hb) 5 in a scale from 1 to 7) over the last 2 months.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of canagliflozin on glucose levels, insulin and gut hormones after a meal in patients without diabetes after weight-loss surgery.;Secondary Objective: To investigate the effect of canagliflozin on glucose levels and the incidence of low blood glucose levels during daily life (assessed through a continuous glucose monitoring system) in patients without diabetes after weight-loss surgery. Moreover, we will assess the effect of canagliflozin and low blood glucose symptoms after consumption of a meal in patients without diabetes after weight-loss surgery. ;Primary end point(s): The difference in nadir (lowest) glucose levels between the two treatment options (canagliflozin 300mg vs no treatment) during the standardised mixed meal test for RYGB and SG (separate analysis for subjects who have undergone RYGB and for subjects who have undergone SG). For patients who will develop hypoglycaemia during the MMTT (defined as glucose levels =3.0 mmol/l) and the test will be stopped for safety reasons, the glucose levels at the time that the test will be completed will be taken into account as the nadir glucose level.;Timepoint(s) of evaluation of this end point: 5 days after initiation of canagliflozin 300mg once daily (vs 5 days with "no treatment"). These investigations will take place at day 5 and day 32 of the study.	—

Measure

Time frame

Main Objective: To investigate the effect of canagliflozin on glucose levels, insulin and gut hormones after a meal in patients without diabetes after weight-loss surgery.;Secondary Objective: To investigate the effect of canagliflozin on glucose levels and the incidence of low blood glucose levels during daily life (assessed through a continuous glucose monitoring system) in patients without diabetes after weight-loss surgery. Moreover, we will assess the effect of canagliflozin and low blood glucose symptoms after consumption of a meal in patients without diabetes after weight-loss surgery. ;Primary end point(s): The difference in nadir (lowest) glucose levels between the two treatment options (canagliflozin 300mg vs no treatment) during the standardised mixed meal test for RYGB and SG (separate analysis for subjects who have undergone RYGB and for subjects who have undergone SG). For patients who will develop hypoglycaemia during the MMTT (defined as glucose levels =3.0 mmol/l) and the test will be stopped for safety reasons, the glucose levels at the time that the test will be completed will be taken into account as the nadir glucose level.;Timepoint(s) of evaluation of this end point: 5 days after initiation of canagliflozin 300mg once daily (vs 5 days with "no treatment"). These investigations will take place at day 5 and day 32 of the study.

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Secondary

Measure	Time frame
Secondary end point(s): 1.Difference in Area Under the Curve (AUC)(0-180), fasting and peak glucose levels after MMTT between the two treatment options (cana 300mg vs no treatment) after RYGB and SG 2.Difference in AUC(0-180) insulin, fasting and peak insulin levels after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 3.Difference in AUC(0-180) Glucagon Like Peptide-1 (GLP-1), fasting and peak GLP-1 levels after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 4.Difference in AUC(0-180) c-peptide, fasting and peak c-peptide levels after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 5.Difference in AUC(0-180) glucagon, fasting and peak glucagon levels after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 6.Difference in the ratio AUC(0-180) insulin/AUC(0-180) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 7.Difference in the ratio AUC(0-30) insulin/AUC(0-30) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 8.Difference in the ratio AUC(60-180) insulin/AUC(60-180) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 9.Difference in the ratio AUC(0-180) c-peptide/AUC(0-180) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 10.Difference in the ratio AUC(0-30) c-peptide/AUC(0-30) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 11.Difference in the ratio AUC(60-180) c-peptide/AUC(60-180) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 12.Difference in the ratio of maximum/minimum plasma glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 13.Difference in AUC(0-180) of Sigs	—

Measure

Time frame

Secondary end point(s): 1.Difference in Area Under the Curve (AUC)(0-180), fasting and peak glucose levels after MMTT between the two treatment options (cana 300mg vs no treatment) after RYGB and SG 2.Difference in AUC(0-180) insulin, fasting and peak insulin levels after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 3.Difference in AUC(0-180) Glucagon Like Peptide-1 (GLP-1), fasting and peak GLP-1 levels after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 4.Difference in AUC(0-180) c-peptide, fasting and peak c-peptide levels after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 5.Difference in AUC(0-180) glucagon, fasting and peak glucagon levels after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 6.Difference in the ratio AUC(0-180) insulin/AUC(0-180) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 7.Difference in the ratio AUC(0-30) insulin/AUC(0-30) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 8.Difference in the ratio AUC(60-180) insulin/AUC(60-180) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 9.Difference in the ratio AUC(0-180) c-peptide/AUC(0-180) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 10.Difference in the ratio AUC(0-30) c-peptide/AUC(0-30) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 11.Difference in the ratio AUC(60-180) c-peptide/AUC(60-180) glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 12.Difference in the ratio of maximum/minimum plasma glucose after MMTT between the two treatment options (Cana 300mg vs no treatment) after RYGB and SG 13.Difference in AUC(0-180) of Sigs

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Countries

United Kingdom

Contacts

Public ContactDr Dimitris Papamargaritis

Leicester Diabetes Centre

dimitris.papamargaritis@uhl-tr.nhs.uk01162588973

Outcome results

None listed

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