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LIRA-Ramadan™

CompletedPhase 4Results posted

Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

343

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥20•HbA1c 7-10%

Primary endpoint

•Fructosamine From Start of Ramadan

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 IDNCT01917656

Org study IDNN2211-3987

Secondary IDU1111-1132-9716WHO

Timeline

Milestones

Study first posted2013-08-07estimated

Study start2014-01-09actual

Primary completion2014-09-01actual

Study completion2014-09-04actual

Results first posted2015-10-07estimated

Last update posted2017-08-24actual

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

•- Subjects diagnosed with T2DM and treated with metformin equal to or above 1000 mg/day and SU (gliclazide, glipizide or glyburide/glibenclamide at maximum tolerated dose (at least half maximum approved dose) or glimepiride at maximum tolerated dose (at least 2 mg/day)), both at a stable dose for at least 90 days prior to screening. Stable is defined as unchanged medication and dose

•- HbA1c 7.0-10.0% (53- 86 mmol/mol) (both inclusive)

•- Body Mass Index (BMI) equal to or above 20 kg/m^2

•- Subjects who have expressed their intention to fast (daytime, i.e. between sunrise and sunset) during Ramadan after receiving medical counselling regarding the risk of fasting

Exclusion criteria

•- Any contraindication for successful and sustained fasting from a medical perspective at the discretion of the investigator (such as acute illness, severe hypoglycaemia within 90 days prior to screening, a history of recurrent hypoglycaemia, hypoglycaemia unawareness, ketoacidosis within 90 days prior to screening, hyperosmolar hyperglycaemic coma within 90 days prior to screening, subjects performing intense physical labour)

•- Any chronic disorder or severe disease which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol

•- History of chronic pancreatitis or idiopathic acute pancreatitis

•- Screening calcitonin value equal to or above 50 ng/L

•- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)

•- Impaired liver function, defined as alanine aminotransferase (ALAT) equal to or above 2.5 times upper normal limit (UNL)

•- Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m^2 per Modification of Diet in Renal Disease (MDRD) formula)

•- Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening

•- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)

Endpoints (20)

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

2 endpoints

Secondary/registry result

Change From Baseline to End of Ramadan in Body Weight

Time frame:Baseline, day 29

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Liraglutide and Metformin	-5.40	—
Sulfonylurea and Metformin	-1.46	—

Secondary/protocol endpoint

Change From Baseline to End of Ramadan in Body Weight

Time frame:Baseline, day 29

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

14 endpoints

Primary/registry result

Change in Fructosamine From Start of Ramadan to End of Ramadan

Time frame:Day -1, day 29

change from baseline, improvement

Posted result

Group	Value (mean), umol/L	95% CI
Liraglutide and Metformin	-13.2	—
Sulfonylurea and Metformin	-14.9	—

Primary/protocol endpoint

Change in Fructosamine From Start of Ramadan to End of Ramadan

Time frame:Day -1, day 29

change from baseline, improvement

Secondary/registry result

Fructosamine at End of Ramadan

Time frame:Day 29

descriptive

Posted result

Group	Value (mean), umol/L	95% CI
Liraglutide and Metformin	276.8	—
Sulfonylurea and Metformin	284.9	—

Secondary/registry result

Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)

Time frame:Day -1, day 29

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide and Metformin	-0.1	—
Sulfonylurea and Metformin	0.1	—

Secondary/registry result

Change From Baseline to End of Ramadan in Fasting Plasma Glucose

Time frame:Baseline, day 29

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide and Metformin	-1.8	—
Sulfonylurea and Metformin	-0.6	—

Secondary/registry result

Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)

Time frame:Baseline, day 29

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percent (%) glycosylated haemoglobin	95% CI
Liraglutide and Metformin	-1.3	—
Sulfonylurea and Metformin	-0.7	—

Secondary/registry result

Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)

Time frame:Visit 14 (4 weeks post Ramadan)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage (%) of subjects	95% CI
Liraglutide and Metformin	51.0	—
Sulfonylurea and Metformin	29.9	—

Secondary/registry result

Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol), and no Confirmed Hypoglycaemic Episodes

Time frame:Visit 14 (4 weeks post Ramadan)

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia

LOINC 4548-4

Posted result

Group	Value (number), percentage (%) of subjects	95% CI
Liraglutide and Metformin	47.6	—
Sulfonylurea and Metformin	25.2	—

Secondary/protocol endpoint

Fructosamine at End of Ramadan

Time frame:Day 29

descriptive, improvement

Secondary/protocol endpoint

Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)

Time frame:Day -1, day 29

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline to End of Ramadan in Fasting Plasma Glucose

Time frame:Baseline, day 29

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)

Time frame:Baseline, day 29

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)

Time frame:Visit 14 (4 weeks post Ramadan)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol), and no Confirmed Hypoglycaemic Episodes

Time frame:Visit 14 (4 weeks post Ramadan)

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia

LOINC 4548-4

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.

Time frame:Day -1 to day 29

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Events/1000 years of patient exposure	95% CI
Liraglutide and Metformin	246	—
Sulfonylurea and Metformin	623	—

Secondary/registry result

Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.

Time frame:Day -1 to day 29

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events/1000 years of patient exposure	95% CI
Liraglutide and MetforminAdverse events	5258	—
Serious adverse events	164	—
Severe adverse events	411	—
Moderate adverse event	986	—
Mild adverse event	3861	—
Sulfonylurea and MetforminAdverse events	3349	—
Serious adverse events	0	—
Severe adverse events	78	—
Moderate adverse event	779	—
Mild adverse event	2492	—

Secondary/protocol endpoint

Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.

Time frame:Day -1 to day 29

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.

Time frame:Day -1 to day 29

Treatment-emergent AEs (any)

event count, 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

Interventions for people with type 2 diabetes mellitus fasting during Ramadan.
The Cochrane database of systematic reviews2023 Jul 12PMID37435938doi:10.1002/14651858.CD013178.pub2via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of liraglutide compared to sulphonylurea during Ramadan in patients with type 2 diabetes (LIRA-Ramadan): a randomized trial.
Diabetes, obesity & metabolism2016 Oct (month)PMID27376711doi:10.1111/dom.12733via 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.