Clinical trial NCT02963922: Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin
Official title: Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-11-15
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted globally. The aim of this trial is to investigate effect and safety of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus treated with basal insulin.


Eligibility 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 (oral anti-diabetic) (metformin, glitazone, SGLT-2 inhibitor (sodium-glucose cotransporter-2 inhibitors) 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 (glycosylated haemoglobin) 6.0-10.0% (both inclusive) - BMI (body mass index) equal to or above 27 kg/m\^2 - Age at least 18 years at the time of signing informed consent Exclusion Criteria: - Diagnosis of type 1 diabetes - Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8 (see Section 8.2.3) - 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 (dipeptidyl peptidase-4) 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 above or equal to 180 mmHg or diastolic above or equal to110 mmHg). - History of malignancy (except for non-melanoma skin cancer) within the past 5 years

Primary outcomes:
measure: Change in Body Weight (%)
timeFrame: Week 0, week 56
measure: Participants Losing at Least 5% of Baseline Body Weight
timeFrame: Week 56
Secondary outcomes:
measure: Participants Losing More Than 10% of Baseline Body Weight at Week 56
timeFrame: Week 56
measure: Change in Waist Circumference
timeFrame: Week 0, week 56
measure: Change in HbA1c
timeFrame: Week 0, week 56
measure: Change in FPG
timeFrame: Week 0, week 56
measure: Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score
timeFrame: Week 0, week 56
measure: Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score
timeFrame: Week 0, week 56
measure: Change in Total Daily Insulin Dose (U)
timeFrame: Week 0, week 56
measure: Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U)
timeFrame: Week 0, week 56
measure: Change in Total Daily Basal Insulin Dose (U/kg)
timeFrame: Week 0, week 56
measure: Change in Total Daily Insulin Dose (U/kg)
timeFrame: Week 0, week 56
measure: Change in 7-point SMPG Profile Mean Daytime Glucose Value
timeFrame: Week 0, week 56
measure: Change in sBP and dBP
timeFrame: Week 0, week 56
measure: Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA
timeFrame: Week 0, week 56
measure: Change in SF-36: Sub-domains
timeFrame: Week 0, week 56
measure: Change in SF-36: Physical Component Summary (PCS)
timeFrame: Week 0, week 56
measure: Change in SF-36: Mental Component Summary (MCS)
timeFrame: Week 0, week 56
measure: Change in IWQoL-Lite for CT: Pain/Discomfort Domain Score
timeFrame: Week 0, week 56
measure: Change in IWQoL-Lite for CT: Psychosocial Domain Score
timeFrame: Week 0, week 56
measure: Change in IWQoL-Lite for CT: Total Score
timeFrame: Week 0, week 56
measure: Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses
timeFrame: Week 0, week 56
measure: Participants Who Achieved (Yes/no): HbA1c <7% and Weight Loss ≥5%
timeFrame: Week 56
measure: Participants Who Achieved (Yes/no): HbA1c <7%, Weight Loss ≥5% and no Documented Symptomatic Hypoglycaemia
timeFrame: Week 56
measure: Participants Who Achieved (Yes/no): ≥4.3 T-score Points Increase From Baseline in SF-36 Acute Physical Functioning Score
timeFrame: Week 56
measure: Participants Who Achieved (Yes/no): ≥3.8 T-score Points Increase From Baseline in SF-36 Acute PCS
timeFrame: Week 56
measure: Participants Who Achieved (Yes/no): ≥4.6 T-score Points Increase From Baseline in SF-36 Acute MCS
timeFrame: Week 56
measure: Responder Definition Value for IWQoL-Lite for CT Physical Function Domain Score
timeFrame: Week 56
measure: Adverse Events (AEs)
timeFrame: Week 0 to week 56 + 30 days
measure: Number of Hypoglycaemic Episodes
timeFrame: Week 0 to week 56 + 30 days
measure: Change in Physical Examination
timeFrame: Week -1, week 56
measure: Change in Resting Pulse
timeFrame: Week -1, week 56
measure: Change in Electrocardiogram (ECG)
timeFrame: Week -1, week 56
measure: Change in Laboratory Measurements (Haematology) - Haemoglobin
timeFrame: Week 0, week 56
measure: Change in Laboratory Measurements (Haematology) - Haematocrit
timeFrame: Week 0, week 56
measure: Change in Laboratory Measurements (Haematology) - Erythrocytes
timeFrame: Week 0, week 56
measure: Change in Laboratory Measurements (Haematology) - Thrombocytes, Leukocytes
timeFrame: Week 0, week 56
measure: Change in Laboratory Parameters (Biochemistry) - Albumin
timeFrame: Week 0, week 56
measure: Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase
timeFrame: Week 0, week 56
measure: Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea
timeFrame: Week 0, week 56
measure: Change in Laboratory Parameters (Biochemistry) - Total Bilirubin and Creatinine
timeFrame: Week 0, week 56
measure: Change in Laboratory Parameters (Biochemistry) - High Sensitive C-reactive Protein
timeFrame: Week 0, week 56
measure: Change in Laboratory Parameters (Biochemistry) - eGFR
timeFrame: Week 0, week 56
measure: Change in Laboratory Parameters (Biochemistry) - Uric Acid
timeFrame: Week 0, week 56
measure: Change in Laboratory Parameters (Biochemistry) - Calcitonin
timeFrame: Week 0, week 56
measure: Change in Laboratory Parameters (Biochemistry) - Thyroid Stimulating Hormone
timeFrame: Week 0, week 56
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Concord
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Fresno
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Plantation
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Roswell
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Novo Nordisk Investigational Site
state: Hawaii
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Louisville
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: North Dartmouth
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: Butte
country: United States
facility: Novo Nordisk Investigational Site
state: Montana
city: Albany
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Wilmington
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Austin
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Austin
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Winchester
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Calgary
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Novo Nordisk Investigational Site
state: Alberta
city: Halifax
country: Canada
facility: Novo Nordisk Investigational Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: London
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Waterloo
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Quebec
country: Canada
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Essen
country: Germany
facility: Novo Nordisk Investigational Site
city: Falkensee
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Leipzig
country: Germany
facility: Novo Nordisk Investigational Site
city: Münster
country: Germany
facility: Novo Nordisk Investigational Site
city: Rehlingen-Siersburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Saint Ingbert-Oberwürzbach
country: Germany
facility: Novo Nordisk Investigational Site
city: Haifa
country: Israel
facility: Novo Nordisk Investigational Site
city: Jerusalem
country: Israel
facility: Novo Nordisk Investigational Site
city: Kfar Saba
country: Israel
facility: Novo Nordisk Investigational Site
city: Petah-Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel Hashomer
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel-Aviv
country: Israel
facility: Novo Nordisk Investigational Site
city: Bologna
country: Italy
facility: Novo Nordisk Investigational Site
city: Napoli
country: Italy
facility: Novo Nordisk Investigational Site
city: Palermo
country: Italy
facility: Novo Nordisk Investigational Site
city: Rome
country: Italy
facility: Novo Nordisk Investigational Site
city: Guadalajara
country: Mexico
facility: Novo Nordisk Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Novo Nordisk Investigational Site
state: Nuevo León
city: Ankara
country: Turkey
facility: Novo Nordisk Investigational Site
city: Antalya
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Izmir
country: Turkey
facility: Novo Nordisk Investigational Site
Study officials:
References:
citation: Garvey WT, Birkenfeld AL, Dicker D, Mingrone G, Pedersen SD, Satylganova A, Skovgaard D, Sugimoto D, Jensen C, Mosenzon O. Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial. Diabetes Care. 2020 May;43(5):1085-1093. doi: 10.2337/dc19-1745. Epub 2020 Mar 5.