CompletedPhase 2

Effect of Liraglutide as add-on to Metformin Compared to Either Liraglutide or Metformin Alone, or to a Combination of Metformin and a SU (Sulphonylurea) Agent in Subjects With Type 2 Diabetes

Effect on Glycemic Control of Individual Maximum Effective Dose of NNC 90-1170 as Add on Therapy to Metformin Compared to Monotherapy of NNC 90-1170 or Metformin or a Metformin-SU Combination Therapy in Patients With Type 2 Diabetes. A Double-blind, Double-dummy, Randomised, Parallel-group, Dose Titration Study With an Open Labelled OHA Arm

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

145

Study population

Type 2 diabetes

Eligibility highlights

•BMI 25-40•HbA1c 8-13%

Primary endpoint

•Fasting glucose, 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 IDNCT01511172

Org study IDNN2211-1499

Timeline

Milestones

Study first posted2012-01-18estimated

Last update posted2017-01-25estimated

Study start2002-08 (month precision)

Primary completion2002-12actual (month precision)

Study completion2002-12actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients diagnosed with type 2 diabetes and treated with at least 50 % of maximum dose(s) of OHA(s) for at least three months

•Duration of type 2 diabetes diagnosis at least one year

•HbA1c 8.0-13.0%, both inclusive

•Body Mass Index (BMI) between 25-40 kg/m^2, both inclusive.

Exclusion criteria

•Current treatment with thiazolidinediones or insulin initiated within the last four months prior to trial

•Impaired liver function

•Impaired renal function

•Cardiac problems

•Uncontrolled treated/untreated hypertension

•Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial

•Recurrent major hypoglycaemia as judged by the Investigator

•Known or suspected allergy to trial product or related products

•Use of any drug (except for OHAs), which in the Investigator's opinion could interfere with the glucose level

•Known or suspected abuse of alcohol or narcotics

•Any contraindications to metformin or glimepiride according to the local guidelines

Endpoints (11)

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

1 endpoint

Secondary/protocol endpoint/low confidence

Weight

descriptive, improvement

Glycemic / diabetes

8 endpoints

Primary/protocol endpoint

Fasting plasma/serum glucose

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Home monitored fasting plasma glucose

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Home monitored 7-point glucose profile

descriptive, improvement

Secondary/protocol endpoint

Fructosamine

descriptive, improvement

Secondary/protocol endpoint/low confidence

Insulin

descriptive

Secondary/protocol endpoint

C-peptide

C-peptide AUC

descriptive

Secondary/protocol endpoint

HbA1c (glycated haemoglobin A1c)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Beta-cell function and insulin resistance (HOMA model)

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Gastro-intestinal adverse events

descriptive, event

Secondary/protocol endpoint

Other adverse events

descriptive

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

Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials.
Diabetes care2015 Jun (month)PMID25504028doi:10.2337/dc13-1210via CT.gov reference
Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with type 2 diabetes.
Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association2006 Sep (month)PMID17039422doi:10.1055/s-2006-924230via 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 tableno registry results posted yet

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.