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 metformi

Phase 1

• Conditions: Patients with type 2 diabetes poorly controlled with metformin; MedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 23.0Level: PTClassification code 10012607Term: Diabetes mellitus inadequate controlSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-005140-41-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 45

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 < 10 %)
5.Metformin on stable dose (at least 1500 mg/day) for at least 12 weeks before screening and at study initiation
6.Subjects who are women of childbearing potential must agree to utilize a highly effective contraceptive measure throughout the course of the study for the entire duration of the trial and the subsequent 30-day follow-upi n accordance with the CTFG recommendations
7.Subjects are capable of giving informed consent
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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 <3 yrs
12.blood pressure >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified