A study of the acute and chronic effects of dapagliflozin plus saxagliptin addition versus single addition of saxagliptin or dapagliflozin on glucose metabolism in patients with type 2 diabetes poorly controlled with metformin

A PHASE II, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, PARALLEL-GROUP, SINGLE CENTER PILOT STUDY OF THE ACUTE AND CHRONIC EFFECTS OF DAPAGLIFLOZIN PLUS SAXAGLIPTIN IN ADDITION TO METFORMIN VERSUS SINGLE ADDITION OF SAXAGLIPTIN OR DAPAGLIFLOZIN ON GLUCOSE METABOLISM IN PATIENTS WITH TYPE 2 DIABETES POORLY CONTROLLED WITH METFORMIN - Saxa-Dapa1

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005140-41-IT

Enrollment

Registered

2021-06-17

Start date

2017-05-10

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

Patients with type 2 diabetes poorly controlled with metformin MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 23.0 Level: PT Classification code 10012607 Term: Diabetes mellitus inadequate control System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

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Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males and females 2. Age = 35-70 years 3. BMI = 40 Kg/m2 and stable weight (± 3 lbs) over the preceding three months 4. Type 2 diabetes (HbA1c > 7 % and =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. Drugs known to affect glucose metabolism (other than metformin) for more than 14 days during the 12 weeks before screening 2. Known Dapagliflozin and Saxagliptin Excipient Hypersensitivity 3. Type 1 Diabetes or History of Ketoacidosis 4. history of cancer of any type; 5. cerebrovascular or symptomatic peripheral vascular disease; 6. heart disease class III or IV NYHA; 7. Estimated glomerular filtration rate (eGFR) =60 mL/min/1.73m2 or serum creatinine > 1.5mg/dL in men or >1.4mg/dL in women 8. Liver function enzymes higher more than two times the upper limit 9. Ongoing urinary tract infection 10. drug or alcohol abuse; 11. life expectancy 160/100 mmHg 13. 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 14. Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study 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 determine the effect of the combination of dapagliflozin (a SGLT2-inhibitor) and saxagliptin (a DPP-4 inhibitor) on pancreatic hormones secretion and endogenous glucose production in Type 2 diabetic subjects through comparison of the effects of co-administration of Saxagliptin and Dapagliflozin vs. Saxagliptin or Dapagliflozin alone;Secondary Objective: To determine whether the effect of the combination of dapagliflozin (a SGLT2-inhibitor) and saxagliptin (a DPP-4 inhibitor) on glucose, insulin, c-peptide, FFA, GIP, GLP-1, hepatic glucose production and beta-cell function is different as compared to single agent administration;Primary end point(s): The primary endpoint is the difference in basal and post-meal endogenous glucose production (EGP) after 3 days (acute study) and after 4 week (chronic study) treatment with co-administration of Saxagliptin and Dapagliflozin vs. Saxagliptin or Dapagliflozin alone. ;Timepoint(s) of evaluation of this end point: This timepoint will be achieved in a three years study	—

Measure

Time frame

Main Objective: To determine the effect of the combination of dapagliflozin (a SGLT2-inhibitor) and saxagliptin (a DPP-4 inhibitor) on pancreatic hormones secretion and endogenous glucose production in Type 2 diabetic subjects through comparison of the effects of co-administration of Saxagliptin and Dapagliflozin vs. Saxagliptin or Dapagliflozin alone;Secondary Objective: To determine whether the effect of the combination of dapagliflozin (a SGLT2-inhibitor) and saxagliptin (a DPP-4 inhibitor) on glucose, insulin, c-peptide, FFA, GIP, GLP-1, hepatic glucose production and beta-cell function is different as compared to single agent administration;Primary end point(s): The primary endpoint is the difference in basal and post-meal endogenous glucose production (EGP) after 3 days (acute study) and after 4 week (chronic study) treatment with co-administration of Saxagliptin and Dapagliflozin vs. Saxagliptin or Dapagliflozin alone. ;Timepoint(s) of evaluation of this end point: This timepoint will be achieved in a three years study

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Secondary

Measure	Time frame
Secondary end point(s): The secondary end-points are the differences in: ¿ total glucose rate of disappearance, ¿ total and exogenous glucose rate of appearance, ¿ plasma insulin, C-peptide, glucagon, GLP-1, GIP, FFA, ¿ beta-cell function from the test meal based on a model that describes the relationship between insulin secretion and glucose concentration as the sum of two components (16-17), ¿ Peripheral insulin sensitivity assessed by Matsuda¿s Composite Insulin Sensitivity Index (18), Oral Glucose Insulin Sensitivity (OGIS)(19), and Stumvoll¿s Insulin Sensitivity Index (20), after 3 days (acute study) and after 4 week (chronic study) treatment with co-administration of Saxagliptin and Dapagliflozin vs. Saxagliptin or Dapagliflozin alone. ;Timepoint(s) of evaluation of this end point: This timepoint will be achieved in a three years study	—

Measure

Time frame

Secondary end point(s): The secondary end-points are the differences in: ¿ total glucose rate of disappearance, ¿ total and exogenous glucose rate of appearance, ¿ plasma insulin, C-peptide, glucagon, GLP-1, GIP, FFA, ¿ beta-cell function from the test meal based on a model that describes the relationship between insulin secretion and glucose concentration as the sum of two components (16-17), ¿ Peripheral insulin sensitivity assessed by Matsuda¿s Composite Insulin Sensitivity Index (18), Oral Glucose Insulin Sensitivity (OGIS)(19), and Stumvoll¿s Insulin Sensitivity Index (20), after 3 days (acute study) and after 4 week (chronic study) treatment with co-administration of Saxagliptin and Dapagliflozin vs. Saxagliptin or Dapagliflozin alone. ;Timepoint(s) of evaluation of this end point: This timepoint will be achieved in a three years study

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Countries

Italy

Contacts

Public ContactUO MALATTIE METABOLICHE E DIABETOLO

UO MALATTIE METABOLICHE E DIABETOLOGIA

stefano.delprato@med.unipi.it050541521

Outcome results

None listed

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