A clinical trial comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i in subjects with type 2 diabetes mellitus

Phase 1

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 18.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-001596-48-HU
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-02
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

1. Male or female, age = 18 years at the time of signing informed consent
2. Subjects diagnosed (clinically) with type 2 diabetes mellitus
3. HbA1c 7.0-11.0% [53-97 mmol/mol] (both inclusive) by central laboratory analysis
4. Body mass index (BMI) = 20 kg/m^2 and < 40 kg/m^2
5. Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as well as prior insulin treatment for gestational diabetes
6. A stable daily dose for at least 90 days prior to the day of screening of any SGLT2i in monotherapy or in combination with metformin ± DPP4i ± pioglitazone. Use of pioglitazone is not allowed in subjects treated with dapagliflozin

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 376
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Receipt of any investigational medicinal product within 90 days prior to screening
2. Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening
3. Use of glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening
4. Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g., diabetes ketoacidosis) in the previous 90 days prior to the day of the screening
5. Subjects presently classified as being in NYHA Class III or IV
6. Renal impairment estimated Glomerular Filtration Rate < 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
7. Impaired liver function, defined as ALT = 2.5 times upper normal limit at screening
8. Known or suspected hypersensitivity to trial product(s) or related products

Study & Design

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