Phase 3 · Liraglutide

SCALE Insulin trial results

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

Participants
396
Status
completed
Completed
2018-09-25
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02963922), updated at source Mar 30, 2020. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What SCALE Insulin measured first

Change in Body Weight (%)Percentage change · Week 0, week 56 · mean
MeasureLiraglutide 3.0 mgn=198Placebon=198
In-trial observation period-6.0(6.0)-1.5(5.4)
On-drug observation period-6.5(5.8)-1.7(5.2)
Participants Losing at Least 5% of Baseline Body WeightPercentage of participants · Week 56 · number
MeasureLiraglutide 3.0 mgn=198Placebon=198
In-trial observation period51.8023.98
On-drug observation period56.9221.83
Side effects by arm

Side effects in SCALE Insulin

Percent of participants affected, From the date of first dose of trial product (week 0) to end of treatment (week 56) + post treatment follow-up of 30 days.. The most common events the registry lists.

EventLiraglutide 3.0 mgPlacebo
Any serious event8.2%9.6%
Nausea29.7%11.7%
Diarrhoea23.1%15.2%
Nasopharyngitis21.5%18.3%
Vomiting16.4%6.1%
Headache14.9%14.7%
Upper respiratory tract infection12.3%14.7%
Constipation14.4%8.6%
Arthralgia6.2%12.2%
Influenza6.2%11.2%
Decreased appetite9.7%2.5%
Pain in extremity8.2%9.6%
Urinary tract infection3.6%9.6%
Gastroenteritis7.7%2.5%
Fatigue7.2%5.1%
Back pain6.7%6.1%
Dizziness6.7%3.6%
Abdominal pain upper6.2%4.1%
Dyspepsia6.2%2.5%
Hypertension2.1%6.1%
Osteoarthritis3.1%6.1%
Abdominal discomfort5.6%4.1%
Gastrooesophageal reflux disease5.1%1%
Oropharyngeal pain3.6%5.1%
Sinusitis4.6%5.1%
Secondary outcomes

What else it measured

Participants Losing More Than 10% of Baseline Body Weight at Week 56Percentage of participants · Week 56 · number
MeasureLiraglutide 3.0 mgn=198Placebon=198
In-trial observation period22.776.55
On-drug observation period22.565.58
Change in Waist CircumferenceCentimeters (cm) · Week 0, week 56 · mean
MeasureLiraglutide 3.0 mgn=198Placebon=198
In-trial observation period-5.40(6.06)-2.60(5.72)
On-drug observation period-5.71(6.05)-2.78(5.63)
Change in HbA1cPercentage of HbA1c · Week 0, week 56 · mean
MeasureLiraglutide 3.0 mgn=198Placebon=198
In-trial observation period-1.1(1.2)-0.5(1.2)
On-drug observation period-1.2(1.1)-0.7(1.0)
Change in FPGMillimoles per liter (mmol/L) · Week 0, week 56 · mean
MeasureLiraglutide 3.0 mgn=198Placebon=198
In-trial observation period-0.91(3.13)-0.68(3.04)
On-drug observation period-1.05(3.08)-0.96(2.68)
Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning ScoreScore on a scale · Week 0, week 56 · mean
MeasureLiraglutide 3.0 mgn=198Placebon=198
In-trial observation period2.5(7.9)2.6(7.3)
On-drug observation period2.9(7.8)2.5(7.1)
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) ScoreScore on a scale · Week 0, week 56 · mean
MeasureLiraglutide 3.0 mgn=198Placebon=198
In-trial observation period7.3(22.5)6.8(21.5)
On-drug observation period8.2(20.9)6.5(21.8)
Change in Total Daily Insulin Dose (U)Units of insulin dose (U) · Week 0, week 56 · mean
Liraglutide 3.0 mgn=198Placebon=198
3(30)18(38)
Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U)Percentage change · Week 0, week 56 · mean
Liraglutide 3.0 mgn=198Placebon=198
19(121)64(139)
Change in Total Daily Basal Insulin Dose (U/kg)Units of insulin dose per kilogram(U/kg) · Week 0, week 56 · mean
Liraglutide 3.0 mgn=198Placebon=198
0.05(0.33)0.15(0.30)
Change in Total Daily Insulin Dose (U/kg)U/kg · Week 0, week 56 · mean
Liraglutide 3.0 mgn=198Placebon=198
0.05(0.33)0.18(0.37)
Change in 7-point SMPG Profile Mean Daytime Glucose Valuemmol/L · Week 0, week 56 · mean
Liraglutide 3.0 mgn=198Placebon=198
-2.2(2.6)-1.6(2.8)
Change in sBP and dBPMillimeters of mercury (mmHg) · Week 0, week 56 · mean
MeasureLiraglutide 3.0 mgn=198Placebon=198
sBP-6(14)-2(15)
dBP-3(9)-1(9)
The trial

How SCALE Insulin was run

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.

  • liraglutide 3.0 mg
  • Placebo
Who could join the trial

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

Published papers

Papers from SCALE Insulin

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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