Effect and safety of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus treated with basal insuli

Phase 1

• Conditions: Obesity; MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-005619-33-IT
• Lead Sponsor: OVO NORDISK. S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-09-25
• Study Start: 2021-02-15
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 396

Inclusion Criteria

- Informed consent obtained before any trial-related activities. Trial-related activities are any
procedures that are carried out as part of the trial, including activities to determine suitability
for the trial
- Diagnosed with type 2 diabetes mellitus
- Treatment with up to 2 OADs (metformin, glitazone, SGLT-2 inhibitor or sulphonylurea),
- Stable treatment with basal insulin according to its label (no requirement of minimum or maximum dose) for at least 90 days prior to screening, as judged by the investigator
- HbA1c 6.0-10.0% (both inclusive)
- BMI = 27 kg/m2
- Age = 18 years at the time of signing 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 326
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74

Exclusion Criteria

- Diagnosis of type 1 diabetes
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s
questionnaire question 8
- Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator
- Unable or unwilling to perform self-monitoring of plasma glucose according to the protocol and to keep a diabetes diary
- Treatment with any hypoglycaemic medications other than OADs and basal insulin within the past 90 days prior to screening
- Treatment with a DPP-IV inhibitor within the past 90 days prior to screening
- Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months), severe congestive heart failure (NYHA class III, IV), or second degree or greater heart block
- Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN2)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing
potential and not using an adequate contraceptive method (adequate contraceptive measure
as required by local regulation or practice). For Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner
- Use in past 90 days of medications known to induce significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)
- History of pancreatitis (acute or chronic)
- History of major depressive disorder within the past 2 years
- Any lifetime history of a suicide attempt
- Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic =180 mmHg or diastolic =110 mmHg).
- History of malignancy (except for non-melanoma skin cancer) within the past 5 years

Study & Design

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