Study of the Effect of Vildagliptin versus Dapagliflozin on Glucagon Response to Mixed Meal in Metformin-treated Subjects with Type 2 Diabetes

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001334-21-SE

Enrollment

Unknown

Registered

2015-06-17

Start date

2015-08-31

Completion date

Unknown

Last updated

2017-07-24

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

Conditions

Type 2 Diabetes Mellitus

Interventions

Product Name: Vildagliptin Product Code: A10BH02 Pharmaceutical Form: Film-coated tablet Product Name: Dapagliflozin Product Code: A10BX09 Pharmaceutical Form: Film-coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written consent has been given. 2. Patients with type 2 diabetes treated with a stable dose of metformin 3. Age 20-70 years. 4. HbA1c 6.5-8.5% (48-67 mmol/mol) at visit 1. 5. Ability to complete the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: 1. Use of other glucose-lowering therapy than metformin within three months prior to visit 1. 2. A history of any secondary forms of diabetes, e.g., Cushing’s syndrome and acromegaly. 3. Type 1 diabetes, positive GAD antibodies 4. eGFR 7 consecutive days of treatment) within 8 weeks prior to visit 1. 13. Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study 14. Hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effects of vildagliptin versus dapagliflozin on glucagon response to mixed meal ingestion in metformin-treated patients with type 2 diabetes ;Secondary Objective: To compare the effects of vildagliptin versus dapagliflozin oninsulin secretion after mixed meal ingestion in metformin-treated patients with type 2 diabe;Primary end point(s): The effect of vildagliptin and daspagliflozin on the area under the curve (AUC) of the 180 min glucagon levels after mixed meal ingestion;Timepoint(s) of evaluation of this end point: 4 weeks	—

Measure

Time frame

Main Objective: To compare the effects of vildagliptin versus dapagliflozin on glucagon response to mixed meal ingestion in metformin-treated patients with type 2 diabetes ;Secondary Objective: To compare the effects of vildagliptin versus dapagliflozin oninsulin secretion after mixed meal ingestion in metformin-treated patients with type 2 diabe;Primary end point(s): The effect of vildagliptin and daspagliflozin on the area under the curve (AUC) of the 180 min glucagon levels after mixed meal ingestion;Timepoint(s) of evaluation of this end point: 4 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): The effect of vildagliptin and dapagliflozin on 180 min area under the curve of GLP-1, GIP, insulin, C-peptide and estimated ISR (insulin secretory rate). ;Timepoint(s) of evaluation of this end point: 2 weeks	—

Countries

Sweden

Contacts

Public ContactClinical Research Department

Skane University Hospital

Margaretha.M.Persson@skane.se4640332037

Outcome results

None listed

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