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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Short name LIRA-Ramadan™

NCTNCT01917656 (opens ClinicalTrials.gov in a new tab)Other idNN2211-3987Other idU1111-1132-9716
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
343 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
7 countries

Algeria, India, Israel, Lebanon, Malaysia, South Africa, United Arab Emirates

Start
9 Jan 2014
Primary completion
1 Sept 2014
Completion
4 Sept 2014
First posted
7 Aug 2013 (estimated)
Last update posted
24 Aug 2017
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015
  1. Ph 4

    LIRA-Ramadan™

    NCT01917656

    9 Jan 2014 to 4 Sept 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This trial is conducted in Africa and Asia. The aim of the trial is to investigate the efficacy and safety of liraglutide versus sulphonylurea (SU) both in combination with metformin during Ramadan in subjects with type 2 diabetes (T2DM).

Interventions

  • liraglutideDrug
  • metforminDrug
  • sulphonylureaDrug

Arms2

  • Experimental

    Liraglutide+Metformin

    Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.

  • Active comparator

    Sulphonylurea and Metformin

    Subjects continued on pre-trial sulphonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Fructosamine From Start of Ramadan to End of Ramadan

    Time frame · Day -1, day 29

    Registry description

    The level of fructosamine in the blood was used to assess the glycaemic control in the patients during the time period described- from start of Ramadan (day -1, visit 8) to end of Ramadan (day 29, visit 12).

Secondary outcomes(9)

  1. Fructosamine at End of Ramadan

    Time frame · Day 29

    Registry description

    The fructosamine values at the end of Ramadan (visit 12) were presented

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

    Time frame · Day -1, day 29

    Registry description

    The level of FPG in the blood of fasting patients was addressed to monitor glycaemic control during the period described.

  3. Change From Baseline to End of Ramadan in Fasting Plasma Glucose

    Time frame · Baseline, day 29

    Registry description

    The changes from baseline measured postbaseline (i.e., the changes measured on visit 8 and 12) entered as the dependent variables, and visit, treatment, country, and the stratification variables were included as fixed factors and the corresponding values for the specific endpoint measured at randomisation as covariate.

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

    Time frame · Baseline, day 29

    Registry description

    The level of glycosylated haemoglobin in blood was used to assess the glycaemic control of the patients during the time period described.

  5. Change From Baseline to End of Ramadan in Body Weight

    Time frame · Baseline, day 29

  6. 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)

    Registry description

    Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)

  7. 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)

    Registry description

    Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)

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

    Time frame · Day -1 to day 29

  9. 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

    Registry description

    A serious AE was an experience that at any dose resulted in any of the following: Death, a life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, a persistent or significant disability or incapacity, congenital anomaly or birth defect, important medical events. Mild - no or transient symptoms, no interference with the subject's daily activities Moderate - marked symptoms, moderate interference with the subject's daily activities Severe - considerable interference with the subject's daily activities, unacceptable

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Day -1, day 29

Change in Fructosamine From Start of Ramadan to End of Ramadan

GroupValue (umol/L)Spread
Liraglutide and Metformin-13.236.0
Sulfonylurea and Metformin-14.943.0
Secondary and other outcome results(7)
Secondary outcomeMean· Day 29

Fructosamine at End of Ramadan

GroupValue (umol/L)Spread
Liraglutide and Metformin276.844.1
Sulfonylurea and Metformin284.946.6
Secondary outcomeMean· Day -1, day 29

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

GroupValue (mmol/L)Spread
Liraglutide and Metformin-0.12.0
Sulfonylurea and Metformin0.13.8
Secondary outcomeMean· Baseline, day 29

Change From Baseline to End of Ramadan in Fasting Plasma Glucose

GroupValue (mmol/L)Spread
Liraglutide and Metformin-1.83.1
Sulfonylurea and Metformin-0.63.6
Secondary outcomeMean· Baseline, day 29

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

GroupValue (Percent (%) glycosylated haemoglobin)Spread
Liraglutide and Metformin-1.31.1
Sulfonylurea and Metformin-0.70.9
Secondary outcomeLeast squares mean· Baseline, day 29

Change From Baseline to End of Ramadan in Body Weight

GroupValue (kg)Spread
Liraglutide and Metformin-5.400.2205
Sulfonylurea and Metformin-1.460.2139
Secondary outcomeNumber· Visit 14 (4 weeks post Ramadan)

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

GroupValue (percentage (%) of subjects)
Liraglutide and Metformin51.0
Sulfonylurea and Metformin29.9
Secondary outcomeNumber· Visit 14 (4 weeks post Ramadan)

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

GroupValue (percentage (%) of subjects)
Liraglutide and Metformin47.6
Sulfonylurea and Metformin25.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Liraglutide and MetforminLiraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.–2 / 1528 / 152
Sulfonylurea and MetforminSubjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.–0 / 1631 / 163

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2016

6 results

Efficacy and safety of liraglutide compared to sulphonylurea during Ramadan in patients with type 2 diabetes (LIRA-Ramadan): a randomized trial.

Azar et al. 2016Diabetes, obesity & metabolismcited by 36

PMID 27376711PMC5095865DOI 10.1111/dom.12733PUB-27376711

Free to read · publisher termsCC BY-NC-ND6 results
Read at sourceSee results (6)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedLee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2. PMID 37435938

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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