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CompletedPhase 2

A Study of Once-Daily NNC0090-2746 in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase 2a Study With an Open-Label Active Group to Assess the Efficacy and Safety of Once-Daily NNC0090-2746 in Type 2 Diabetic Patients Inadequately Controlled With Metformin

Lead sponsor

Novo Nordisk A/S

Assets

Liraglutide / RG7697 / MAR709

Listed sites

20

Recruiting sites

Enrollment

108

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

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 IDNCT02205528
Org study IDNN9709-4336
Secondary IDU1111-1189-5627World Health Organization (WHO)

Timeline

Milestones

Study first posted2014-07-31estimated
Study start2014-08-18actual
Primary completion2015-09-15actual
Study completion2015-09-15actual
Last update posted2020-07-21actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

Participants aged 18 to 70 years, inclusive
Active diagnosis of T2D for greater than or equal to (>/=) 3 months
For females of childbearing potential and males with female partners of childbearing potential, agreement to use highly effective contraceptive measures
Treated with a stable dose of metformin for at least 8 weeks prior to randomization, and expected to remain at the same stable dose throughout study participation
Hemoglobin A1c (HbA1c) >/= 7.2% and less than or equal to (</=) 10.5%
Fasting plasma glucose (FPG) less than (<) 250 milligrams per deciliter (mg/dL)
C-peptide greater than (>) 1.5 nanograms per milliliter (ng/mL)
Body mass index (BMI) >/= 27 kilograms per meter-squared (kg/m^2) and </= 44 kg/m^2
Stable weight (+/- 5%) within 12 weeks prior to Screening
Willing and able to maintain existing diet and exercise habits throughout the study
Capable of performing SC self-injections on a daily basis during the study

Exclusion criteria

Females who are pregnant or lactating
History of type 1 diabetes (T1D), diabetes resulting from pancreatic injury, or secondary forms of diabetes such as Cushing's Syndrome or acromegaly
History of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia
History of clinically significant diabetic complications such as diabetic proliferative retinopathy or severe diabetic neuropathy (requiring treatment with antidepressants or opioids)
History of severe hypoglycemia within 6 months prior to Screening
History of chronic gastrointestinal (GI) conditions that could impede gastric emptying or potentially affect the interpretation of the study data
History of weight loss surgery or weight loss procedure involving the GI tract, such as gastric bypass, gastric stapling, or gastric banding
History of an eating disorder (e.g., bulimia, anorexia)
History of malignancy (except treated basal or squamous cell skin cancer) within 5 years prior to Screening
Personal or family history of medullary thyroid carcinoma
History of multiple endocrine neoplasia syndrome type 2
History of chronic or acute pancreatitis or hemochromatosis
History of significant cardiovascular disease (such as congestive heart failure New York Heart Association Class II to IV, myocardial infarction within the previous 6 months, coronary disease, or uncontrolled hypertension)
History of clinically significant renal or liver disease
History of hypersensitivity or previous intolerance to incretin or glucagon analogues
Elevations in lipase or amylase levels at Screening > 1.5 times the upper limit of normal (ULN) and considered clinically significant by the investigator
Positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG), or hepatitis C antibody test at Screening
Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to Screening, or active enrollment in another investigational medication or device study
Any condition, disorder, or abnormal laboratory test findings at screening that, in the judgment of the investigator, would interfere with the participant's ability to comply with all study requirements, or would require the administration of a treatment during the study that could potentially affect the interpretation of the study data, or would place the participant at unacceptable risk by his/her participation in the study

Endpoints (10)

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
7
Weight & body composition
2
Safety / tolerability / PK
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change in body weight

Time frame:Day 1; Week 8; Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent change in body weight

Time frame:Day 1; Week 8; Week 12

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

7 endpoints
Primary/protocol endpoint

Change in HbA1c

Time frame:Day 1; Week 8

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:Day 1; Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in post-prandial plasma glucose level

Time frame:Day -7; Week 12

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in post-prandial insulin level

Time frame:Day -7; Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in post-prandial C-peptide level

Time frame:Day -7; Week 12

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Change in beta-cell function

Time frame:Day 1; Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in percent HbA1c

Time frame:Day 1; Week 12

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Incidence of treatment-emergent adverse events

Time frame:Day 1; Week 18

Treatment-emergent AEs (any)

event count, event

Publications (1)

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 1, 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 1, 2026 snapshot.