LIRA-PRIME

CompletedPhase 4Results posted

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

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 Inadequately Controlled With Metformin Monotherapy and Treated in a Primary Care Setting

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

232

Recruiting sites

—

Enrollment

1,991

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7.5-9%

Primary endpoint

•HbA1c <7.0% achievement

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02730377

Org study IDNN2211-4232

Secondary ID2015-002417-29

Secondary IDU1111-1170-7035WHO

Timeline

Milestones

Study start2016-03-28actual

Study first posted2016-04-06estimated

Primary completion2019-08-05actual

Study completion2019-08-12actual

Last update posted2020-07-07actual

Results first posted2020-07-07actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility 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

Endpoints (46)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

Cardiometabolic biomarkers

Renal / kidney

Weight & body composition

MASH / liver

Other (unclassified)

Weight & body composition

4 endpoints

Secondary/registry result

Change in Body Weight

Time frame:Week 0, week 104/premature treatment discontinuation

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram (Kg)	95% CI
Liraglutide 1.8 mgChange at week 104	-3.8	—
Change at premature treatment discontinuation	-2.9	—
Oral Antidiabetic DrugChange at week 104	-3.5	—
Change at premature treatment discontinuation	-2.2	—

Secondary/registry result

Change in Body Mass Index (BMI)

Time frame:Week 0, week 104/premature treatment discontinuation

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), Kilograms per square meter (kg/m^2)	95% CI
Liraglutide 1.8 mgChange at week 104	-1.3	—
Change at premature treatment discontinuation	-1.1	—
Oral Antidiabetic DrugChange at week 104	-1.2	—
Change at premature treatment discontinuation	-0.8	—

Secondary/protocol endpoint

Change in Body Weight

Time frame:Week 0, week 104/premature treatment discontinuation

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:Week 0, week 104/premature treatment discontinuation

BMI, change

change from baseline, improvement

Glycemic / diabetes

14 endpoints

Primary/registry result

Time to Inadequate Glycaemic Control

Time frame:Weeks 26-104

HbA1c <7.0% achievement

time to event, event

LOINC 4548-4

Posted result

Group	Value (median), Weeks	95% CI
Liraglutide 1.8 mg	108.9	37.7 – NA
Oral Antidiabetic Drug	64.9	35.4 – 107.4

p<.0001Log Rank

Test for no treatment difference is based on using a generalised log-rank test for interval censored failure time data.

Primary/protocol endpoint

Time to Inadequate Glycaemic Control

Time frame:Weeks 26-104

HbA1c <7.0% achievement

time to event, event

LOINC 4548-4

Secondary/registry result

Change in HbA1c

Time frame:Week 0, week 104/premature treatment discontinuation

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage point of HbA1c	95% CI
Liraglutide 1.8 mgChange at week 104	-1.4	—
Change at premature treatment discontinuation	-0.6	—
Oral Antidiabetic DrugChange at week 104	-1.1	—
Change at premature treatment discontinuation	-0.2	—

Secondary/registry result

Participants Who Achieve HbA1c ≤6.5% (Yes/No)

Time frame:Week 104/Premature treatment discontinuation

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 1.8 mg	255	—
	741	—
Oral Antidiabetic Drug	162	—
	833	—

Secondary/registry result

Participants Who Achieve HbA1c ≤7.0% Without Weight Gain

Time frame:Week 104/Premature treatment discontinuation

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 1.8 mg	329	—
	667	—
Oral Antidiabetic Drug	234	—
	761	—

Secondary/registry result

Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 104/Premature treatment discontinuation

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Documented hypoglycemia

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 1.8 mg	388	—
	608	—
Oral Antidiabetic Drug	292	—
	703	—

Secondary/registry result/low confidence

Participants Who Achieve HbA1c ≤7.0% Without Weight Gain and no Treatment Emergent Severe Hypoglycaemic Episodes or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 104/Premature treatment discontinuation

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Severe hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 1.8 mg	320	—
	676	—
Oral Antidiabetic Drug	227	—
	768	—

Secondary/registry result

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 104/premature treatment discontinuation

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
Liraglutide 1.8 mgChange at week 104	-2.2	—
Change at premature treatment discontinuation	-0.6	—
Oral Antidiabetic DrugChange at week 104	-1.2	—
Change at premature treatment discontinuation	-0.6	—

Secondary/protocol endpoint

Change in HbA1c

Time frame:Week 0, week 104/premature treatment discontinuation

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieve HbA1c ≤6.5% (Yes/No)

Time frame:Week 104/Premature treatment discontinuation

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieve HbA1c ≤7.0% Without Weight Gain

Time frame:Week 104/Premature treatment discontinuation

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 104/Premature treatment discontinuation

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieve HbA1c ≤7.0% Without Weight Gain and no Treatment Emergent Severe Hypoglycaemic Episodes or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 104/Premature treatment discontinuation

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Severe hypoglycemia, Documented hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 104/premature treatment discontinuation

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

MASH / liver

1 endpoint

Secondary/protocol endpoint

Change in Biochemistry- Alanine Aminotransferase (ALAT), Amylase, Aspartate Aminotransferase (ASAT), Lipase

Time frame:Week 0, week 104/premature treatment discontinuation

ALT, change

change from baseline, improvement

LOINC 1742-6

Renal / kidney

5 endpoints

Secondary/registry result/low confidence

Change in Biochemistry- Creatinine, Total Bilirubin

Time frame:Week 0, week 104/premature treatment discontinuation

change from baseline, improvement

Posted result

Group	Value (mean), Micromoles per liter (umol/L)	95% CI
Liraglutide 1.8 mgCreatinine: week 104	3.3	—
Creatinine: premature treatment discontinuation	2.9	—
TB: week 104	0.4	—
TB: premature treatment discontinuation	-0.0	—
Oral Antidiabetic DrugCreatinine: week 104	1.0	—
Creatinine: premature treatment discontinuation	2.6	—
TB: week 104	0.7	—
TB: premature treatment discontinuation	-0.6	—

Secondary/registry result

Change in Biochemistry- Estimated Glomerular Filtration Rate (eGFR) Serum

Time frame:Week 0, week 104/premature treatment discontinuation

eGFR, change

change from baseline, improvement

Posted result

Group	Value (mean), mL/min/SSA	95% CI
Liraglutide 1.8 mgChange at week 104	-5.1	—
Change at premature treatment discontinuation	-3.0	—
Oral Antidiabetic DrugChange at week 104	-1.6	—
Change at premature treatment discontinuation	-1.7	—

Secondary/registry result

Change in Potassium

Time frame:Week 0, week 104/premature treatment discontinuation

change from baseline, descriptive

LOINC 2823-3

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
Liraglutide 1.8 mgChange at week 104	-0.1	—
Change at premature treatment discontinuation	-0.0	—
Oral Antidiabetic DrugChange at week 104	-0.0	—
Change at premature treatment discontinuation	-0.2	—

Secondary/protocol endpoint/low confidence

Change in Biochemistry- Creatinine, Total Bilirubin

Time frame:Week 0, week 104/premature treatment discontinuation

change from baseline, improvement

Secondary/protocol endpoint

Change in Biochemistry- Estimated Glomerular Filtration Rate (eGFR) Serum

Time frame:Week 0, week 104/premature treatment discontinuation

eGFR, change

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints

Secondary/registry result

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Time frame:Week 0, week 104/premature treatment discontinuation

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), Millimeters of mercury (mmHg)	95% CI
Liraglutide 1.8 mgSBP: Change at week 104	-2.4	—
SBP: Change at premature treatment discontinuation	-2.8	—
DBP: Change at week 104	-1.3	—
DBP: Change at premature treatment discontinuation	-1.0	—
Oral Antidiabetic DrugSBP: Change at week 104	-1.1	—
SBP: Change at premature treatment discontinuation	-2.9	—
DBP: Change at week 104	-0.6	—
DBP: Change at premature treatment discontinuation	0.2	—

Secondary/registry result

Change in Lipids: HDL Cholesterol, LDL-cholesterol, Total Cholesterol, Triglycerides

Time frame:Week 0, week 104/premature treatment discontinuation

change from baseline, improvement

Posted result

Group	Value (mean), Millimoles per liter (mmol/L)	95% CI
Liraglutide 1.8 mgHDL: Change at week 104	0.1	—
HDL: Change at premature treatment discontinuation	-0.0	—
LDL: Change at week 104	-0.1	—
LDL: Change at premature treatment discontinuation	-0.1	—
TC: Change at week 104	-0.2	—
TC: Change at premature treatment discontinuation	-0.0	—
TG: Change at week 104	-0.3	—
TG: Change at premature treatment discontinuation	-0.0	—
Oral Antidiabetic DrugHDL: Change at week 104	0.1	—
HDL: Change at premature treatment discontinuation	0.0	—
LDL: Change at week 104	0.0	—
LDL: Change at premature treatment discontinuation	-0.1	—
TC: Change at week 104	0.1	—
TC: Change at premature treatment discontinuation	-0.1	—
TG: Change at week 104	-0.1	—
TG: Change at premature treatment discontinuation	-0.0	—

Secondary/registry result

Change in Pulse

Time frame:Week 0, week 104/premature treatment discontinuation

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute (beats/min)	95% CI
Liraglutide 1.8 mgChange at week 104	1.0	—
Change at premature treatment discontinuation	0.7	—
Oral Antidiabetic DrugChange at week 104	-0.6	—
Change at premature treatment discontinuation	0.9	—

Secondary/protocol endpoint

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Time frame:Week 0, week 104/premature treatment discontinuation

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Lipids: HDL Cholesterol, LDL-cholesterol, Total Cholesterol, Triglycerides

Time frame:Week 0, week 104/premature treatment discontinuation

change from baseline, improvement

Secondary/protocol endpoint

Change in Pulse

Time frame:Week 0, week 104/premature treatment discontinuation

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

15 endpoints

Secondary/registry result

Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control)

Time frame:Weeks 0-104

Discontinuation due to AE

time to event, event

Posted result

Group	Value (median), Weeks	95% CI
Liraglutide 1.8 mg	80.4	35.7 – NA
Oral Antidiabetic Drug	52.3	35.1 – NA

Secondary/registry result

Number of Severe Hypoglycaemic Episodes

Time frame:Weeks 0-104

Severe hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Liraglutide 1.8 mg	32	—
Oral Antidiabetic Drug	52	—

Secondary/registry result

Number of Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-104

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Liraglutide 1.8 mg	24	—
Oral Antidiabetic Drug	44	—

Secondary/registry result

Number of Documented Symptomatic Hypoglycaemic Episodes (ADA)

Time frame:Weeks 0-104

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Liraglutide 1.8 mg	98	—
Oral Antidiabetic Drug	155	—

Secondary/registry result

Number of Serious Adverse Events (SAEs)

Time frame:Weeks 0-105

Serious AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Liraglutide 1.8 mg	145	—
Oral Antidiabetic Drug	140	—

Secondary/registry result

Number of AEs Leading to Permanent Discontinuation of Trial Product

Time frame:Weeks 0-105

Discontinuation due to AE

event count, event

Posted result

Group	Value (number), Events	95% CI
Liraglutide 1.8 mg	188	—
Oral Antidiabetic Drug	98	—

Secondary/registry result/low confidence

Change in Biochemistry- Alanine Aminotransferase (ALAT), Amylase, Aspartate Aminotransferase (ASAT), Lipase

Time frame:Week 0, week 104/premature treatment discontinuation

change from baseline, descriptive

componentsALT, change, AST, change, Pancreatitis, Pancreatitis

Posted result

Group	Value (mean), Units per liter (U/L)	95% CI
Liraglutide 1.8 mgALAT: Week 104	-4.6	—
ALAT: Premature treatment discontinuation	-3.2	—
Amylase: Week 104	8.9	—
Amylase: Premature treatment discontinuation	0.6	—
ASAT: Week 104	-2.0	—
ASAT: Premature treatment discontinuation	-1.9	—
Lipase: Week 104	15.1	—
Lipase: Premature treatment discontinuation	10.4	—
Oral Antidiabetic DrugALAT: Week 104	-5.4	—
ALAT: Premature treatment discontinuation	-3.3	—
Amylase: Week 104	5.1	—
Amylase: Premature treatment discontinuation	2.1	—
ASAT: Week 104	-2.3	—
ASAT: Premature treatment discontinuation	-0.4	—
Lipase: Week 104	-0.5	—
Lipase: Premature treatment discontinuation	-2.2	—

Secondary/registry result

Change in Haemoglobin

Time frame:Week 0, week 104/premature treatment discontinuation

change from baseline, descriptive

Posted result

Group	Value (mean), Grams per deciliter (g/dL)	95% CI
Liraglutide 1.8 mgChange at week 104	-0.4	—
Change at premature treatment discontinuation	-0.3	—
Oral Antidiabetic DrugChange at week 104	-0.0	—
Change at premature treatment discontinuation	-0.3	—

Secondary/protocol endpoint

Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control)

Time frame:Weeks 0-104

Discontinuation due to AE

time to event, event

Secondary/protocol endpoint

Number of Severe Hypoglycaemic Episodes

Time frame:Weeks 0-104

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Weeks 0-104

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Documented Symptomatic Hypoglycaemic Episodes (ADA)

Time frame:Weeks 0-104

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Events (SAEs)

Time frame:Weeks 0-105

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of AEs Leading to Permanent Discontinuation of Trial Product

Time frame:Weeks 0-105

Discontinuation due to AE

event count, event

Secondary/protocol endpoint

Change in Potassium

Time frame:Week 0, week 104/premature treatment discontinuation

change from baseline, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in Haemoglobin

Time frame:Week 0, week 104/premature treatment discontinuation

change from baseline, descriptive

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
Maintenance of glycaemic control with liraglutide versus oral antidiabetic drugs as add-on therapies in patients with type 2 diabetes uncontrolled with metformin alone: A randomized clinical trial in primary care (LIRA-PRIME).
Diabetes, obesity & metabolism2022 Feb (month)PMID34622567doi:10.1111/dom.14566via pubmed nct search
Trial design and baseline data for LIRA-PRIME: A randomized trial investigating the efficacy of liraglutide in controlling glycaemia in type 2 diabetes in a primary care setting.
Diabetes, obesity & metabolism2019 Jul (month)PMID30828917doi:10.1111/dom.13682via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.