Obesity MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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, alpha glucosidase inhibitor, glinide or sulphonylurea), - Stable treatment with basal insulin (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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm superiority of liraglutide 3.0 mg vs. placebo, as an adjunct to a reduced-calorie diet and increased physical activity, on weight loss effectiveness in subjects with overweight or obesity and type 2 diabetes mellitus (T2DM) treated with a basal insulin and up to 2 oral antidiabetic (OAD) medications (metformin, glitazone, SGLT-2 inhibitor, alpha glucosidase inhibitor, glinide or sulphonylurea). ; Secondary Objective: 1. To establish the effects of liraglutide 3.0 mg vs. placebo, as an adjunct to a reduced-calorie diet and increased physical activity, on relevant efficacy endpoints in subjects with overweight or obesity and T2DM treated with basal insulin and up to 2 OADs (metformin, glitazone, SGLT-2 inhibitor, alpha glucosidase inhibitor, glinide or sulphonylurea) 2. To establish the safety and tolerability of liraglutide 3.0 mg vs. placebo, as an adjunct to a reducedcalorie diet and increased physical activity, in subjects with overweight or obesity and T2DM treated with basal insulin and up to 2 OADs (metformin, glitazone, SGLT-2 inhibitor, alpha glucosidase inhibitor, glinide or sulphonylurea) ; Primary end point(s): 1. Change in body weight (%) 2. Proportion of subjects losing at least 5% of baseline body weight ; Timepoint(s) of evaluation of this end point: 1. from baseline to week 56 2. week 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of subjects losing more than 10% of baseline body weight 2. Change in waist circumference 3. Change in HbA1c 4. Change in fasting plasma glucose 5. Change in Short Form-36 (SF-36) v2.0 acute, physical functioning score 6. Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), physical function domain (5-items) score ; Timepoint(s) of evaluation of this end point: 1. week 56 2.-6. from baseline to week 56 | — |
Countries
Canada, European Union, Germany, Israel, Mexico, Turkey, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed