GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

132

Recruiting sites

—

Enrollment

346

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7.5-10%

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 IDNCT01664247

Org study IDNN1250-3944

Secondary ID2011-004665-32

Secondary IDU1111-1124-6612WHO

Timeline

Milestones

Study first posted2012-08-14estimated

Study start2012-10-01actual

Primary completion2013-12-31actual

Study completion2013-12-31actual

Results first posted2016-04-20estimated

Last update posted2017-09-25actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes

•Insulin naïve

•Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only twice daily (BID))

•Glycosylated haemoglobin (HbA1c) (by central laboratory analysis): a. 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy, b. 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or exenatide (only BID)

Exclusion criteria

•Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks

•Calcitonin equal to or above 50 pg/mL

•Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks

•Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)

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

Patient-reported / QoL

Glycemic / diabetes

12 endpoints

Primary/registry result

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of glycosylated haemoglobin	95% CI
IDeg	-0.99	—
Placebo	-0.07	—

Primary/protocol endpoint

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
IDeg	-2.60	—
Placebo	-0.28	—

Secondary/registry result

Number of Responders for HbA1c (Below 7.0 %)

Time frame:After 26 weeks of randomised treatment.

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage (%) of subjects	95% CI
IDeg	77.6	—
Placebo	35.5	—

Secondary/registry result

Change From Baseline in Mean Pre-breakfast Measurements Used for Titration

Time frame:Week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
IDeg	5.88	—
Placebo	8.23	—

Mean Difference (Final Values)-2.3495% CI-2.67 – -2.01p<.0001ANOVA

The pre-breakfast measures of SMPG values after 26 weeks of treatment were analysed an ANOVA method with treatment, region and sex as fixed effects, and age and baseline response as covariates.

Secondary/registry result

Change From Baseline in 8-point Profile

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
IDegBefore breakfast, N=170, 164	5.85	—
90 min after breakfast, N=153, 148	7.65	—
Before lunch, N=151,149	6.33	—
90 min after lunch, N=152,150	7.73	—
Before evening meal, N=154,148	6.77	—
90 mins after evening meal, N=147,145	7.93	—
Before bedtime, N=148, 142	7.21	—
Before breakfast the next day, N=164,161	6.05	—
PlaceboBefore breakfast, N=170, 164	8.54	—
90 min after breakfast, N=153, 148	9.75	—
Before lunch, N=151,149	8.34	—
90 min after lunch, N=152,150	9.67	—
Before evening meal, N=154,148	9.51	—
90 mins after evening meal, N=147,145	9.65	—
Before bedtime, N=148, 142	8.95	—
Before breakfast the next day, N=164,161	8.55	—

Mean Difference (Final Values)-2.6995% CI-3.04 – -2.34p<.0001Mixed Models Analysis

Mean Difference (Final Values)-2.0995% CI-2.71 – -1.48p<.0001Mixed Models Analysis

Mean Difference (Final Values)-2.0195% CI-2.47 – -1.56p<.0001Mixed Models Analysis

Median Difference (Final Values)-1.9395% CI-2.46 – -1.40p<.0001Mixed Models Analysis

Mean Difference (Final Values)-1.7495% CI-2.25 – -1.23p<.0001Mixed Models Analysis

Mean Difference (Final Values)-1.7295% CI-2.26 – -1.18p<.0001Mixed Models Analysis

Mean Difference (Final Values)-1.7595% CI-2.27 – -1.23p<.0001Mixed Models Analysis

Mean Difference (Final Values)-2.5095% CI-2.91 – -2.09p<.0001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Mean of the 8-point Profile

Time frame:Week 0, week 26

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
IDeg	-2.3	—
Placebo	-0.5	—

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Number of Responders for HbA1c (Below 7.0 %)

Time frame:After 26 weeks of randomised treatment.

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Mean Pre-breakfast Measurements Used for Titration

Time frame:Week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in 8-point Profile

Time frame:Week 0, week 26

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Mean of the 8-point Profile

Time frame:Week 0, week 26

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/registry result

Change From Baseline in Patient Reported Health-related Quality of Life Using the Short-Form 36 Health Survey Version 2 (SF-36®v2)

Time frame:Week 0, week 26

SF-36 total

change from baseline, improvement

Posted result

Group	Value (mean), T-scores	95% CI
IDegPhysical health	0.5	—
Mental health	0.6	—
PlaceboPhysical health	0.0	—
Mental health	-0.7	—

Secondary/protocol endpoint

Change From Baseline in Patient Reported Health-related Quality of Life Using the Short-Form 36 Health Survey Version 2 (SF-36®v2)

Time frame:Week 0, week 26

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Number of Hypoglycaemic Episodes

Time frame:Weeks 0 - 26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), events	95% CI
IDeg	47	—
Placebo	9	—

Secondary/registry result

Number of Adverse Events

Time frame:Weeks 0 - 26

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), events	95% CI
IDeg	285	—
Placebo	252	—

Secondary/protocol endpoint

Number of Hypoglycaemic Episodes

Time frame:Weeks 0 - 26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Adverse Events

Time frame:Weeks 0 - 26

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

Effect of adding insulin degludec to treatment in patients with type 2 diabetes inadequately controlled with metformin and liraglutide: a double-blind randomized controlled trial (BEGIN: ADD TO GLP-1 Study).
Diabetes, obesity & metabolism2016 Jul (month)PMID26990378doi:10.1111/dom.12661via 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.