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Phase 4 Completed N=1,991 Randomized Treatment

Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes

Source: ClinicalTrials.gov NCT02730377 ↗
Enrolled (actual)
1,991
Serious AEs
8.8%
Results posted
Jul 2020
Primary outcomePrimary: Time to Inadequate Glycaemic Control — 108.9; 64.9 Weeks — p=<.0001
◆ Published Evidence
Emerging
10citations · ~10 / year
Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews · 2025 · Open access · Likely link

Summary

This trial is conducted globally. The aim of the trial is to investigate efficacy in controlling glycaemia with Victoza® (liraglutide) as add-on to metformin background treatment vs. OADs as add-on to metformin background treatment for 104 weeks of treatment in subjects with type 2 diabetes.

Linked Publications

  • Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
    The Cochrane database of systematic reviews · 2025 · 10 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to Inadequate Glycaemic Control
108.9; 64.9 <.0001 sig
SECONDARY
Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control)
80.4; 52.3
SECONDARY
Change in HbA1c
-1.4; -1.1; -0.6; -0.2
SECONDARY
Participants Who Achieve HbA1c ≤6.5% (Yes/No)
255; 162; 741; 833
SECONDARY
Participants Who Achieve HbA1c ≤7.0% Without Weight Gain
329; 234; 667; 761
SECONDARY
Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes
388; 292; 608; 703
SECONDARY
Participants Who Achieve HbA1c ≤7.0% Without Weight Gain and no Treatment Emergent Severe Hypoglycaemic Episodes or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes
320; 227; 676; 768
SECONDARY
Change in Fasting Plasma Glucose (FPG)
-2.2; -1.2; -0.6; -0.6
SECONDARY
Change in Body Weight
-3.8; -3.5; -2.9; -2.2
SECONDARY
Change in Body Mass Index (BMI)
-1.3; -1.2; -1.1; -0.8
SECONDARY
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
-2.4; -1.1; -2.8; -2.9; -1.3; -0.6
SECONDARY
Number of Severe Hypoglycaemic Episodes
32; 52
SECONDARY
Number of Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
24; 44
SECONDARY
Number of Documented Symptomatic Hypoglycaemic Episodes (ADA)
98; 155
SECONDARY
Number of Serious Adverse Events (SAEs)
145; 140
SECONDARY
Number of AEs Leading to Permanent Discontinuation of Trial Product
188; 98
SECONDARY
Change in Lipids: HDL Cholesterol, LDL-cholesterol, Total Cholesterol, Triglycerides
0.1; 0.1; -0.0; 0.0; -0.1; 0.0
SECONDARY
Change in Biochemistry- Alanine Aminotransferase (ALAT), Amylase, Aspartate Aminotransferase (ASAT), Lipase
-4.6; -5.4; -3.2; -3.3; 8.9; 5.1
SECONDARY
Change in Biochemistry- Creatinine, Total Bilirubin
3.3; 1.0; 2.9; 2.6; 0.4; 0.7
SECONDARY
Change in Biochemistry- Estimated Glomerular Filtration Rate (eGFR) Serum
-5.1; -1.6; -3.0; -1.7
SECONDARY
Change in Potassium
-0.1; -0.0; -0.0; -0.2
SECONDARY
Change in Haemoglobin
-0.4; -0.0; -0.3; -0.3
SECONDARY
Change in Pulse
1.0; -0.6; 0.7; 0.9

Eligibility Criteria

Inclusion Criteria: - Male or female at least 18 years of age at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes equal to or above 90 days prior to the screening visit - Stable daily dose of metformin as monotherapy equal to or above 1500 mg or maximum tolerated dose within 60 days prior to the screening visit - HbA1c 7.5-9.0% (59-75 mmol/mol) (both inclusive) and measured within the last 90 days prior to the screening visit Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) - Treatment with any medication for the indication of diabetes other than metformin in a period of 60 days before the screening visit. An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with intercurrent illness - Receipt of any investigational medicinal product within 30 days before the screening visit - Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02730377) 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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