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← All trials/NCT01511198

CompletedPhase 2

Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent

NNC 90-1170 Dose-response, Efficacy and Safety: A 12-week Randomized, Multicenter, Doubleblind, Double-dummy, Parallel-group Study of Metformin and Five Doses of NNC 90-1170 in Previously-treated OHA Monotherapy Obese Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

39

Recruiting sites

-

Actual enrollment

223

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI 27-42

Primary endpoint

•Body weight

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 IDNCT01511198
Org study IDNN2211-2072

Timeline

Milestones

Study first posted2012-01-18estimated
Last update posted2017-01-26estimated
Study start2001-02 (month precision)
Primary completion2001-10actual (month precision)
Study completion2001-10actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetic
•Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed
•Body Mass Index (BMI) between 27.0-42.0 kg/m^2 (inclusive)
•HbA1c maximum 10% based on analysis from central laboratory

Exclusion criteria

•Cardiac problems
•Uncontrolled treated/untreated hypertension
•Proliferative retinopathy or known autonomic neuropathy
•Recurrent severe hypoglycemia 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 investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed
•Known or suspected abuse of alcohol or narcotics
•Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
•TSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL
•Type 1 or other specific causes of diabetes

Endpoints (6)

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
3
Weight & body composition
1
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

Body weight

descriptive, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

FPG (fasting plasma glucose)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

HbA1c (glycosylated haemoglobin)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fructosamine

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint/low confidence

Lipids

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

descriptive, 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

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.