CompletedPhase 3Results posted

The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

451

Study population

Type 2 diabetes

Eligibility highlights

•BMI 20-45•HbA1c 7-10%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01617434

Org study IDNN2211-3917

Secondary ID2011-002696-41

Secondary IDU1111-1121-9874WHO

Timeline

Milestones

Study first posted2012-06-12estimated

Results first posted2014-10-28estimated

Last update posted2017-03-08actual

Study start2012-09 (month precision)

Primary completion2013-10actual (month precision)

Study completion2013-10actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 U/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator)

•HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive)

•Body mass index (BMI) 20-45 kg/m^2 (both inclusive)

Exclusion criteria

•Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant

•Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness

•Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening

•Impaired liver or renal function

•Uncontrolled treated or untreated hypertension (systolic blood pressure (SBP) equal to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg)

•Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial

•Known or suspected abuse of alcohol or narcotics

Endpoints (18)

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

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/registry result

Change in Body Weight From Baseline to Week 26

Time frame:Week 0 to Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Mean · kg	95% CI
Liraglutide	-3.54	-
Placebo	-0.42	-

Mean difference (final values)-3.1195% CI-3.85 - -2.37p<0.0001Mixed Models Analysis

The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.

Secondary/protocol endpoint

Change in Body Weight From Baseline to Week 26

Time frame:Week 0 to Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

10 endpoints

Primary/registry result

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26

Time frame:Week 0 to Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Mean · percentage of glycosylated haemoglobin	95% CI
Liraglutide	-1.30	-
Placebo	-0.11	-

Mean difference (final values)-1.1995% CI-1.39 - -0.99p<0.0001Mixed Models Analysis

Primary/protocol endpoint

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26

Time frame:Week 0 to Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

Time frame:Week 0 to Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Mean · mmol/L	95% CI
Liraglutide	-1.44	-
Placebo	-0.16	-

Mean difference (final values)-1.2895% CI-1.70 - -0.86p<0.0001Mixed Models Analysis

The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.

Secondary/registry result

Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26

Time frame:Week 0 to Week 26

change from baseline, improvement

Posted result

Group	Mean · mmol/L	95% CI
Liraglutide	-2.61	-
Placebo	-1.02	-

Mean difference (final values)-1.5995% CI-2.01 - -1.18p<0.0001Mixed Models Analysis

The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.

Secondary/registry result

Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)

Time frame:At Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · percentage of subjects	95% CI
Liraglutide	59.24	-
Placebo	14.02	-

Odds ratio (or)8.9195% CI5.45 - 14.59p<0.0001Regression, Logistic

Secondary/registry result

Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)

Time frame:At Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · percentage of subjects	95% CI
Liraglutide	42.91	-
Placebo	3.60	-

Odds ratio (or)20.1295% CI9.92 - 40.84p<0.0001Regression, Logistic

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

Time frame:Week 0 to Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26

Time frame:Week 0 to Week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)

Time frame:At Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)

Time frame:At Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

6 endpoints

Secondary/registry result

Number of Adverse Events (AEs) During The Randomised Treatment Period

Time frame:Week 0 to Week 26 + 7 days follow up

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Number · Events/1000 years of patient exposure	95% CI
LiraglutideAdverse Events	4918	-
Serious Adverse Events	149	-
Severe Adverse Events	169	-
Moderate Adverse Events	1274	-
Mild Adverse Events	3474	-
PlaceboAdverse Events	3737	-
Serious Adverse Events	101	-
Severe Adverse Events	101	-
Moderate Adverse Events	1060	-
Mild Adverse Events	2575	-

Secondary/registry result

Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period

Time frame:Week 0 to Week 26 + 7 days follow up

Documented hypoglycemia

event count, event

Posted result

Group	Number · Events/100 years of patient exposure	95% CI
Liraglutide	126	-
Placebo	83	-

Secondary/registry result

Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period

Time frame:Week 0 to Week 26 + 7 days follow up

Severe hypoglycemia

event count, event

Posted result

Group	Number · Events/100 years of patient exposure	95% CI
Liraglutide	0	-
Placebo	0	-

Secondary/protocol endpoint

Number of Adverse Events (AEs) During The Randomised Treatment Period

Time frame:Week 0 to Week 26 + 7 days follow up

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period

Time frame:Week 0 to Week 26 + 7 days follow up

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period

Time frame:Week 0 to Week 26 + 7 days follow up

Severe hypoglycemia

event count, event

Publications (2)

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

IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy.
Diabetes therapy : research, treatment and education of diabetes and related disorders2015 Dec (month)PMID26582052doi:10.1007/s13300-015-0142-yvia CT.gov reference
Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial.
Diabetes, obesity & metabolism2015 Nov (month)PMID26179619doi:10.1111/dom.12539via CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.