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Phase 3 Completed N=396 Randomized Double-blind Treatment

Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin

Metabolism and Nutrition Disorder · Obesity
Source: ClinicalTrials.gov NCT02963922 ↗
Enrolled (actual)
396
Serious AEs
8.9%
Results posted
Nov 2019
Primary outcomePrimary: Change in Body Weight (%) — -6.0; -1.5; -6.5; -1.7 Percentage change — p=< .0001
◆ Published Evidence
Highly cited
179citations · ~30 / year
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 · Open access · High-confidence link

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.

Linked Publications

  • 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 · 179 citations · Open access · High-confidence link

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Body Weight (%)
-6.0; -1.5; -6.5; -1.7 < .0001 sig
PRIMARY
Participants Losing at Least 5% of Baseline Body Weight
51.80; 23.98; 56.92; 21.83 <.0001 sig
SECONDARY
Participants Losing More Than 10% of Baseline Body Weight at Week 56
22.77; 6.55; 22.56; 5.58
SECONDARY
Change in Waist Circumference
-5.40; -2.60; -5.71; -2.78
SECONDARY
Change in HbA1c
-1.1; -0.5; -1.2; -0.7
SECONDARY
Change in FPG
-0.91; -0.68; -1.05; -0.96
SECONDARY
Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score
2.5; 2.6; 2.9; 2.5
SECONDARY
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score
7.3; 6.8; 8.2; 6.5
SECONDARY
Change in Total Daily Insulin Dose (U)
3; 18
SECONDARY
Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U)
19; 64
SECONDARY
Change in Total Daily Basal Insulin Dose (U/kg)
0.05; 0.15
SECONDARY
Change in Total Daily Insulin Dose (U/kg)
0.05; 0.18
SECONDARY
Change in 7-point SMPG Profile Mean Daytime Glucose Value
-2.2; -1.6
SECONDARY
Change in sBP and dBP
-6; -2; -3; -1
SECONDARY
Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA
-0.12; 0.04; 0.05; 0.03; -0.08; 0.05
SECONDARY
Change in SF-36: Sub-domains
1.2; 1.2; 1.9; 0.3; 2.5; 2.6
SECONDARY
Change in SF-36: Physical Component Summary (PCS)
2.7; 2.2
SECONDARY
Change in SF-36: Mental Component Summary (MCS)
-1.9; -1.7
SECONDARY
Change in IWQoL-Lite for CT: Pain/Discomfort Domain Score
4.0; 4.6
SECONDARY
Change in IWQoL-Lite for CT: Psychosocial Domain Score
5.4; 4.0
SECONDARY
Change in IWQoL-Lite for CT: Total Score
5.7; 4.8
SECONDARY
Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses
11; 5; 74; 85; 17; 18
SECONDARY
Participants Who Achieved (Yes/no): HbA1c <7% and Weight Loss ≥5%
39.9; 13.6
SECONDARY
Participants Who Achieved (Yes/no): HbA1c <7%, Weight Loss ≥5% and no Documented Symptomatic Hypoglycaemia
10.1; 3.5
SECONDARY
Participants Who Achieved (Yes/no): ≥4.3 T-score Points Increase From Baseline in SF-36 Acute Physical Functioning Score
28.8; 26.3
SECONDARY
Participants Who Achieved (Yes/no): ≥3.8 T-score Points Increase From Baseline in SF-36 Acute PCS
37.9; 31.3
SECONDARY
Participants Who Achieved (Yes/no): ≥4.6 T-score Points Increase From Baseline in SF-36 Acute MCS
14.6; 11.6
SECONDARY
Responder Definition Value for IWQoL-Lite for CT Physical Function Domain Score
25.3; 24.2
SECONDARY
Adverse Events (AEs)
1223; 1148
SECONDARY
Number of Hypoglycaemic Episodes
1538; 1973
SECONDARY
Change in Physical Examination
165; 169; 25; 25; 5; 3
SECONDARY
Change in Resting Pulse
2; -0
SECONDARY
Change in Electrocardiogram (ECG)
113; 133; 78; 60; 4; 4
SECONDARY
Change in Laboratory Measurements (Haematology) - Haemoglobin
-0.1; -0.1
SECONDARY
Change in Laboratory Measurements (Haematology) - Haematocrit
-0.4; -0.2
SECONDARY
Change in Laboratory Measurements (Haematology) - Erythrocytes
-0.07; -0.04
SECONDARY
Change in Laboratory Measurements (Haematology) - Thrombocytes, Leukocytes
7; 7; -0.22; -0.24
SECONDARY
Change in Laboratory Parameters (Biochemistry) - Albumin
-0.1; -0.1
SECONDARY
Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase
-1; -0; -5; -6; 13; -1
SECONDARY
Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea
0; -0; -0.00; -0.02; -0.0; -0.0
SECONDARY
Change in Laboratory Parameters (Biochemistry) - Total Bilirubin and Creatinine
1.0; 0.6; -0.1; -0.2
SECONDARY
Change in Laboratory Parameters (Biochemistry) - High Sensitive C-reactive Protein
-1.40; -1.29
SECONDARY
Change in Laboratory Parameters (Biochemistry) - eGFR
0; 1
SECONDARY
Change in Laboratory Parameters (Biochemistry) - Uric Acid
-0.2; -0.0
SECONDARY
Change in Laboratory Parameters (Biochemistry) - Calcitonin
0.0; 0.0
SECONDARY
Change in Laboratory Parameters (Biochemistry) - Thyroid Stimulating Hormone
-0.0842; 0.1002

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02963922) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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