GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2

Addition of Liraglutide to Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections

Addition of Liraglutide to Overweight Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections (MDI) With Inadequate Glycaemic Control

Lead sponsor

Vastra Gotaland Region

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

124

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27.5•HbA1c ≥7.5%

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 IDNCT02113332

Org study IDMDILiraglutide

Secondary ID2012-001941-42

Timeline

Milestones

Study first posted2014-04-14estimated

Last update posted2015-02-03estimated

Study start2013-01 (month precision)

Primary completion2014-08actual (month precision)

Study completion2014-08actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management)

•Type 2 diabetes

•Adult patients over 18 years of age and less than or equal to 80 years of age

•HbA1c greater than or equal to 7.5% (NGSP standard=DCCT standard)=58 mmol/mol (IFCC standard) and less than or equal to 11.5%=102 mmol/mol

•Treated with MDI for at least the last 6 months

•Treated with/without metformin as only diabetes therapy apart from insulin

•Fasting C-peptide of 0.10 nmol/l or greater (ref. 0.25-1.0 nmol/l)

•BMI greater than 27,5 kg/m2 and less than 45 kg/m2

Exclusion criteria

•Type 1 diabetes

•Fasting glucose less than 6.0 mmol/l or greater than 15.0 mmol/l

•Unstable cardiovascular disease, NYHA Class II or greater heart failure , new symptoms of cardiovascular disease)

•Proliferative diabetic retinopathy or clinically significant macula oedema. Retinal photograph should not be older than 3 years.

•Systemic glucocorticoid treatment during the last 3 months, however, patients using systemic corticoid treatment only for substitution of cortisol deficiency (physiologic doses) such as Addisons Disease, do not need to be excluded

•Acute coronary syndrome, stroke, coronary artery intervention or myocardial infarction during the previous 6 months

•Creatinine greater than 150 micromol/l

•Liver transaminases greater than double of the normal reference interval

•Treatment with other oral antidiabetic agents than metformin during the previous 3 months

•Treatment with GLP-1 receptor agonists within 90 days of screening

•Severe psychiatric disorder (untreated severe depression, schizophrenia, dementia or severe alcohol or drug abuse)

•Frequent non-severe hypoglycaemia (greater than 2 times per week) or any severe hypoglycaemia during the previous month.

•Hypoglycaemic unawareness

•Current cancer or diagnosis of cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer).

•Personal history of non-familial thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN2)

•Screening calcitonin values greater than 14.6 pmol/l.

•Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice; accepted methods: oral contraceptive pills, depo provera contraceptive injections, implanted contraceptive, transdermal patch, intrauterine device, vasectomized partner, or abstinence.)

•Blood pressure greater than 160/100 mmHg

•Need for continuous use of paracetamol. During the 3 periods of 7 days with CGM, paracetamol cannot be used. Alternative pain killers can be substituted if plausible because paracetamol is the only medication influencing CGM results.

•History of chronic or acute pancreatitis

•Inflammatory Bowel Disease

•Participation in another study

Endpoints (19)

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

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in weight from baseline to week 24

Time frame:Baseline, week 24

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

9 endpoints

Primary/protocol endpoint

Change in HbA1c from baseline to week 24.

Time frame:Baseline, week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting glucose from baseline to week 24

Time frame:Baseline, week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in the standard deviation of CGM from the run-in period to week 23-24

Time frame:Run-in period, week 23-24

change from baseline, improvement

Secondary/protocol endpoint

Change in mean glucose levels on CGM from the run-in period to week 23-24

Time frame:Run-in period, week 23-24

change from baseline, improvement

Secondary/protocol endpoint

Change in 1.5 hour postprandial glucose levels on capillary glucose measurements from the run-in period to week 23-24

Time frame:Run-in period, week 23-24

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Proportion of patients with HbA1c less than 8.0% (64 mmol/mol) at week 24

Time frame:Week 24

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of patients with HbA1c less than 7.5% (58 mmol/mol) at week 24

Time frame:Week 24

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in total insulin dose from baseline to week 24

Time frame:Baseline, week 24

change from baseline, improvement

Secondary/protocol endpoint

Proportion of patients with HbA1c less than 7.0% (53 mmol/mol) at week 24

Time frame:Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change in blood pressure from baseline to week 24

Time frame:Baseline, week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in blood lipid levels from baseline to week 24

Time frame:Baseline, week 24

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Change in the score of the DTSQs from baseline to week 24

Time frame:Baseline, week 24

change from baseline, improvement

Secondary/protocol endpoint

Score of the DTSQc at week 24

Time frame:Week 24

descriptive, improvement

Safety / tolerability / PK

5 endpoints

Secondary/protocol endpoint

Frequency of non-severe documented symptomatic hypoglycaemia (plasma glucose [PG] less than 4.0 mmol/l) from baseline to week 24

Time frame:Baseline, week 24

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Frequency of asymptomatic non-severe hypoglycaemia (PG less than 4.0 mmol/l) from baseline to week 24

Time frame:Baseline, week 24

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Frequency of non-severe documented symptomatic hypoglycaemia (PG less than 3.0 mmol/l) from baseline to week 24

Time frame:Baseline, week 24

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Frequency of asymptomatic non-severe hypoglycaemia (PG less than 3.0 mmol/l) from baseline to week 24

Time frame:Baseline, week 24

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Frequency of severe hypoglycaemia from baseline to week 24

Time frame:Baseline, week 24

Severe hypoglycemia

event count, event

Publications (9)

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

Design and methods of a randomised double-blind trial of adding liraglutide to control HbA1c in patients with type 2 diabetes with impaired glycaemic control treated with multiple daily insulin injections (MDI-Liraglutide trial).
Primary care diabetes2015 Feb (month)PMID25175385doi:10.1016/j.pcd.2014.07.010via clinicaltrials gov reference derived + pubmed nct search
Incretin therapy and its effect on body weight in patients with diabetes.
Primary care diabetes2012 Oct (month)PMID22613745doi:10.1016/j.pcd.2012.04.006via CT.gov background
Glucagon-like peptide 1 (GLP-1) analogue combined with insulin reduces HbA1c and weight with low risk of hypoglycemia and high treatment satisfaction.
Primary care diabetes2012 Apr (month)PMID22015237doi:10.1016/j.pcd.2011.09.002via CT.gov background
Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial.
Lancet (London, England)2010 Apr 24PMID20417856doi:10.1016/S0140-6736(10)60307-8via CT.gov background
Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes.
Diabetes, obesity & metabolism2010 Feb (month)PMID20092585doi:10.1111/j.1463-1326.2009.01173.xvia CT.gov background
Standards of medical care in diabetes--2010.
Diabetes care2010 Jan (month)PMID20042772doi:10.2337/dc10-S011via CT.gov background
The impact of weight gain on motivation, compliance, and metabolic control in patients with type 2 diabetes mellitus.
Postgraduate medicine2009 Sep (month)PMID19820278doi:10.3810/pgm.2009.09.2056via CT.gov background
Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia.
Diabetes care2005 May (month)PMID15855602doi:10.2337/diacare.28.5.1245via CT.gov background
Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group.
Lancet (London, England)1998 Sep 12PMID9742976via CT.gov background

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.