GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT00393718

CompletedPhase 3Results posted

Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

400

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤35•HbA1c ≥7%

Primary endpoint

•HbA1c, change

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 IDNCT00393718

Org study IDNN2211-1700

Timeline

Milestones

Study first posted2006-10-30estimated

Results first posted2010-03-12estimated

Last update posted2017-03-08actual

Study start2006-11 (month precision)

Primary completion2007-11actual (month precision)

Study completion2008-05actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes

•Diet/exercise therapy with or without an oral anti-diabetic drug for at least eight weeks

•HbA1c greater than or equal to 7.0% and less than 10.0%

•BMI (Body Mass Index) less than 35 kg/m2

Exclusion criteria

•Treatment with insulin within the last 12 weeks

•Treatment with any drug that could interfere with the glucose level

•Any serious medical condition

•Females who are pregnant, have intention of becoming pregnant or are breastfeeding

Endpoints (26)

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

Weight & body composition

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/registry result

Body Weight After 24 Weeks of Treatment

Time frame:after 24 weeks of treatment

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Liraglutide	64.06	—
Glibenclamide	65.97	—

Least Squares Mean-1.9195% CI-2.34 – -1.48p<0.0001ANOVA

Secondary/registry result

Body Weight After 52 Weeks of Treatment

Time frame:after 52 weeks of treatment

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Liraglutide	64.30	—
Glibenclamide	66.01	—

Least Squares Mean-1.7195% CI-2.25 – -1.18ANOVA

Secondary/protocol endpoint

Body Weight After 24 Weeks of Treatment

Time frame:after 24 weeks of treatment

descriptive, improvement

Secondary/protocol endpoint

Body Weight After 52 Weeks of Treatment

Time frame:after 52 weeks of treatment

descriptive, improvement

Glycemic / diabetes

20 endpoints

Primary/registry result

Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment

Time frame:after 24 weeks of treatment

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of total haemoglobin	95% CI
Liraglutide	6.99	—
Glibenclamide	7.50	—

Least Squares Mean-0.5095% CI-0.70 – -0.30p<0.0001ANOVA

Primary/protocol endpoint

Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment

Time frame:after 24 weeks of treatment

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment

Time frame:after 52 weeks of treatment

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of total haemoglobin	95% CI
Liraglutide	7.31	—
Glibenclamide	7.80	—

Least Squares Mean-0.4995% CI-0.71 – -0.27ANOVA

Secondary/registry result

Fasting Plasma Glucose After 24 Weeks of Treatment

Time frame:after 24 weeks of treatment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Liraglutide	137.2	—
Glibenclamide	150.1	—

Least Squares Mean-12.995% CI-18.2 – -7.5p<0.0001ANOVA

Secondary/registry result

Fasting Plasma Glucose After 52 Weeks of Treatment

Time frame:after 52 weeks of treatment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Liraglutide	145.8	—
Glibenclamide	157.5	—

Least Squares Mean-11.795% CI-18.6 – -4.9ANOVA

Secondary/registry result

Postprandial Glucose AUC After 24 Weeks of Treatment

Time frame:after 24 weeks of treatment

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL *h	95% CI
Liraglutide	557.54	—
Glibenclamide	670.60	—

Least Squares Mean-93.0595% CI-119.61 – -66.50p<0.0001ANOVA

Secondary/registry result

Postprandial Glucose AUC After 52 Weeks of Treatment

Time frame:after 52 weeks of treatment

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL *h	95% CI
Liraglutide	608.66	—
Glibenclamide	683.17	—

Least Squares Mean-74.5195% CI-105.75 – -43.27ANOVA

Secondary/registry result

Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment

Time frame:after 24 weeks of treatment

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Liraglutide	155.98	—
Glibenclamide	173.61	—

Least Squares Mean-17.6395% CI-25.00 – -10.27p<0.0001ANOVA

Secondary/registry result

Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment

Time frame:after 52 weeks of treatment

Postprandial glucose

descriptive, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Liraglutide	167.39	—
Glibenclamide	184.60	—

Least Squares Mean-17.2195% CI-26.32 – -8.09ANOVA

Secondary/registry result

Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment

Time frame:after 24 weeks of treatment

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Liraglutide	59.69	—
Glibenclamide	79.66	—

Least Squares Mean-19.9795% CI-27.99 – -11.94p<0.0001ANOVA

Secondary/registry result

Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment

Time frame:after 52 weeks of treatment

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
Liraglutide	63.56	—
Glibenclamide	76.59	—

Least Squares Mean-13.0395% CI-21.46 – -4.60ANOVA

Secondary/protocol endpoint

Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment

Time frame:after 52 weeks of treatment

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting Plasma Glucose After 24 Weeks of Treatment

Time frame:after 24 weeks of treatment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Fasting Plasma Glucose After 52 Weeks of Treatment

Time frame:after 52 weeks of treatment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Postprandial Glucose AUC After 24 Weeks of Treatment

Time frame:after 24 weeks of treatment

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

Postprandial Glucose AUC After 52 Weeks of Treatment

Time frame:after 52 weeks of treatment

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment

Time frame:after 24 weeks of treatment

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment

Time frame:after 52 weeks of treatment

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment

Time frame:after 24 weeks of treatment

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment

Time frame:after 52 weeks of treatment

Postprandial glucose

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Hypoglycaemic Episodes

Time frame:over 52 weeks of treatment

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), number of events per year of exposure	95% CI
LiraglutideAll hypoglycaemic episodes	0.694	—
Major	0.000	—
Minor	0.187	—
Symptoms only	0.507	—
GlibenclamideAll hypoglycaemic episodes	3.843	—
Major	0.000	—
Minor	1.103	—
Symptoms only	2.740	—

Rate ratio0.2095% CI0.12 – 0.35Negative binomial regression model

Rate ratio0.1895% CI0.09 – 0.36Negative binomial regression model

Rate ratio0.2095% CI0.11 – 0.34Negative binomial regression model

Secondary/protocol endpoint

Hypoglycaemic Episodes

Time frame:over 52 weeks of treatment

Documented hypoglycemia

event count, event

Publications (5)

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

A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer.
Diabetes research and clinical practice2012 Nov (month)PMID23010561doi:10.1016/j.diabres.2012.09.008via CT.gov reference
The once-daily human glucagon-like peptide-1 analog, liraglutide, improves β-cell function in Japanese patients with type 2 diabetes.
Journal of diabetes investigation2012 Aug 20PMID24843595doi:10.1111/j.2040-1124.2012.00193.xvia CT.gov reference + pubmed nct search
Fifty-two-week, randomized, multicenter trial to compare the safety and efficacy of the novel glucagon-like peptide-1 analog liraglutide vs glibenclamide in patients with type 2 diabetes.
Journal of diabetes investigation2011 Nov 30PMID24843528doi:10.1111/j.2040-1124.2011.00128.xvia pubmed nct search
GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide.
The Journal of clinical endocrinology and metabolism2011 Mar (month)PMID21209033doi:10.1210/jc.2010-2318via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes.
Current medical research and opinion2010 May (month)PMID20199137doi:10.1185/03007991003672551via CT.gov reference + pubmed nct search

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.