Measurement of the effect of Canagliflozin versus Placebo in type 2 diabetes during insulin-mediated hypoglycemia

A PHASE II, RANDOMIZED, CROSS-OVER, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE CENTER STUDY OF THE EFFECT OF THE ACUTE ADMINISTRATION OF THE SGLT-2 INHIBITOR CANAGLIFLOZIN ON CONTERREGULATORY RESPONSE TO INSULIN-INDUCED HYPOGLYCEMIA - CANA-1

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003126-16-IT

Enrollment

Registered

2021-06-08

Start date

2016-10-27

Completion date

Unknown

Last updated

2025-02-10

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: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: INVOKANA - 300 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE BLISTER (PVC/ALU) - 30 COMPRESSE Product Name: INVOKANA Product Code: INVOKANA Pharmaceutical Form: Capsule, hard INN or Propos

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males and females 2. Age = 30-60 years 3. BMI= = 35 Kg/m2 and stable weight (± 3 lbs) over the preceding three months 4. Type 2 diabetes (HbA1c > 7 % and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Drugs known to affect glucose metabolism (other than metformin) 2. Known Canagliflozin Excipient Hypersensitivity 3. Liver function enzymes higher more than two times the upper limit 4. Heart Failure (NYHA III-IV) 5. Ongoing urinary tract infection 6. Blood pressure >140/90 mmHg 7. Loop diuretics or thiazide diuretics therapy 8. Hematocrit > 52% 9. Type 1 Diabetes 10. Diabetic Ketoacidosis 11. GFR 300 mg 14. Donation of blood to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 400 mL of blood during the 8 weeks prior to the enrollment visit and at least 8 weeks thereafter 15. Women who are pregnant or breastfeeding 16. Patient with a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient or interfere with trial procedures

Design outcomes

Primary

Measure	Time frame
Main Objective: To test the hypothesis that a single canagliflozin (300 mg) oral administration in subjects with type 2 diabetes affects glucagon response to insulin-induced hypoglycaemia as compared to placebo;Secondary Objective: To test the hypothesis that a single canagliflozin (300 mg) oral administration in subjects with type 2 diabetes affects during hypoglycaemia as compared to placebo: -Endogenous glucose production -FFA, lactate, alanine, glycerol. -Insulin -C-peptide, cortisol, growth hormone -Adrenaline and noradrenaline -Hypoglycemic symptom score with the Edinburgh Hypoglycemia Symptom Scale, a subjective, validated questionnaire that measures the intensity of commonly experienced hypoglycemic symptoms on a 7-point Likert scale (1 = not present, 7 = very intense) (Performed by Dr. Angela Dardano). -Cognitive function measured by Mini Mental State Examination (MMSE) and Mental Deterioration Battery (modified version) (MDB) (Performed by Dr. Angela Dardano). -Change in area under the curve of glucose infusion rate as average amount of glucose infused. ;Primary end point(s): The primary endpoint is the change in plasma glucagon concentration during the hypoglycemic clamp and during the recovery phase with canagliflozin vs. placebo in patients with type 2 diabetes;Timepoint(s) of evaluation of this end point: This timepoint will be achieved in a three years study	—

Measure

Time frame

Main Objective: To test the hypothesis that a single canagliflozin (300 mg) oral administration in subjects with type 2 diabetes affects glucagon response to insulin-induced hypoglycaemia as compared to placebo;Secondary Objective: To test the hypothesis that a single canagliflozin (300 mg) oral administration in subjects with type 2 diabetes affects during hypoglycaemia as compared to placebo: -Endogenous glucose production -FFA, lactate, alanine, glycerol. -Insulin -C-peptide, cortisol, growth hormone -Adrenaline and noradrenaline -Hypoglycemic symptom score with the Edinburgh Hypoglycemia Symptom Scale, a subjective, validated questionnaire that measures the intensity of commonly experienced hypoglycemic symptoms on a 7-point Likert scale (1 = not present, 7 = very intense) (Performed by Dr. Angela Dardano). -Cognitive function measured by Mini Mental State Examination (MMSE) and Mental Deterioration Battery (modified version) (MDB) (Performed by Dr. Angela Dardano). -Change in area under the curve of glucose infusion rate as average amount of glucose infused. ;Primary end point(s): The primary endpoint is the change in plasma glucagon concentration during the hypoglycemic clamp and during the recovery phase with canagliflozin vs. placebo in patients with type 2 diabetes;Timepoint(s) of evaluation of this end point: This timepoint will be achieved in a three years study

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary end-points are changes during hypoglycemic clamp and during the recovery phase in: - Endogenous glucose production - FFA, lactate, alanine, glycerol. - Insulin - C-peptide, cortisol, growth hormone - Adrenaline and noradrenaline - Hypoglycemic symptom score with the Edinburgh Hypoglycemia Symptom Scale, a subjective, validated questionnaire that measures the intensity of commonly experienced hypoglycemic symptoms on a 7-point Likert scale (1 = not present, 7 = very intense) (Performed by Dr. Angela Dardano). - Cognitive function measured by Mini Mental State Examination (MMSE) and Mental Deterioration Battery (modified version) (MDB) (Performed by Dr. Angela Dardano). - Change in area under the curve of glucose infusion rate as average amount of glucose infused. ;Timepoint(s) of evaluation of this end point: timepoints will be achieved in a three years study	—

Measure

Time frame

Secondary end point(s): The secondary end-points are changes during hypoglycemic clamp and during the recovery phase in: - Endogenous glucose production - FFA, lactate, alanine, glycerol. - Insulin - C-peptide, cortisol, growth hormone - Adrenaline and noradrenaline - Hypoglycemic symptom score with the Edinburgh Hypoglycemia Symptom Scale, a subjective, validated questionnaire that measures the intensity of commonly experienced hypoglycemic symptoms on a 7-point Likert scale (1 = not present, 7 = very intense) (Performed by Dr. Angela Dardano). - Cognitive function measured by Mini Mental State Examination (MMSE) and Mental Deterioration Battery (modified version) (MDB) (Performed by Dr. Angela Dardano). - Change in area under the curve of glucose infusion rate as average amount of glucose infused. ;Timepoint(s) of evaluation of this end point: timepoints will be achieved in a three years study

—

Countries

Italy

Contacts

Public ContactUO MALATTIE METABOLICHE E DIABETOLO

UO MALATTIE METABOLICHE E DIABETOLOGIA

stefano.delprato@med.unipi.it050995103

Outcome results

None listed

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