Evaluation of modified-release Exenatide or Sitagliptin in addition to baseline insulin in the modification of new cardiovascular risk markers in subjects with type 2 diabetes mellitus

Phase 1

• Conditions: Diabetes mellitus type 2; MedDRA version: 21.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-004326-15-IT
• Lead Sponsor: IVERSITÀ DEGLI STUDI G. D'ANNUNZIO CHIETI-PESCARA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

For inclusion in the study subjects should fulfill the following criteria:
1.Provision of informed consent prior to any study specific procedures
2.White/Caucasian Female or male aged between 40 and 70 years
3.T2DM diagnosed since at least 2 years;
4.Baseline HbA1c between 7.5 and 9% (as incretin based therapy reimbursement drug starting range in Italy);
5.Diabetes and Cardiovascular risk factors treatment unchanged during the last 3 months;
6.Not treated with DPP-IV inhibitors or GLP-Rxs during the last 6 months;
7.Not treated with SGLT-2 inhibitors during the last 6 months;
8.On a stable dose of metformin (at least 1000mg/qd) since at least 3 months
9.On stable Basal insulin therapy (glargine) + 10% since at least 3 months;
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 20

Exclusion Criteria

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
1.Baseline HbA1c between <7.5 or > 9.0%;
2.T1DM or T2DM diagnosed less than 2 years;
3.Not White/Caucasian aged below 40 and over 70 years
4.Diabetes and Cardiovascular risk factors treatment changed during the last 3 months;
5.Treated with DPP-IV inhibitors or GLP-Rxs during the last 6 months;
6.Treated with SGLT-2 inhibitors during the last 6 months;
7.On different therapy than Basal insulin therapy (glargine) + OAD since at least 3 months;
8.Previous Cardiovascular Events;
9.Known disease of the immune system.
10.Known or suspected hypersensitivity to the trial product or related products.
11.Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice.
12.Participation in another clinical trial of an investigational medicinal product. Participation in a clinical trial which evaluate stent(s) is allowed.
13.Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
14.History of pancreatitis (acute or chronic).
15.Planned coronary, carotid or peripheral artery revascularization known on the day of screening.
16.Chronic or intermittent hemodialysis or peritoneal dialysis or moderate renal impairment (corresponding to eGFR <50 mL/min/1.73 m2).
17.History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).
18.History of diabetic ketoacidosis.

Study & Design

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