Phase 4
Completed N=1,991
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.
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
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Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
Outcome Measures
| Outcome | Result | p-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
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.