Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes (LIRA-Ramadan™)

July 25, 2017 updated by: Novo Nordisk A/S
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

343

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Algiers, Algeria, 16000
        • Novo Nordisk Investigational Site
      • Constantine, Algeria, 25000
        • Novo Nordisk Investigational Site
      • Oran, Algeria, 31000
        • Novo Nordisk Investigational Site
      • Setif, Algeria, 19000
        • Novo Nordisk Investigational Site
      • Sidi Bel Abbes, Algeria, 22000
        • Novo Nordisk Investigational Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
        • Novo Nordisk Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380007
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Novo Nordisk Investigational Site
      • Mysore, Karnataka, India, 570001
        • Novo Nordisk Investigational Site
      • Mysore, Karnataka, India, 570004
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400058
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400010
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411001
        • Novo Nordisk Investigational Site
  • Israel
      • Beer Sheva, Israel, 84101
        • Novo Nordisk Investigational Site
      • Haifa, Israel, 31096
        • Novo Nordisk Investigational Site
      • Haifa, Israel, 35152
        • Novo Nordisk Investigational Site
      • Jerusalem, Israel, 93106
        • Novo Nordisk Investigational Site
  • Lebanon
      • Beirut, Lebanon
        • Novo Nordisk Investigational Site
      • Lebanon - Beirut, Lebanon, 9611
        • Novo Nordisk Investigational Site
  • Malaysia
      • Cheras, Malaysia, 56000
        • Novo Nordisk Investigational Site
      • Ipoh, Perak, Malaysia, 30990
        • Novo Nordisk Investigational Site
      • Klang, Selangor, Malaysia, 41200
        • Novo Nordisk Investigational Site
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Novo Nordisk Investigational Site
      • Putrajaya, Malaysia, 62250
        • Novo Nordisk Investigational Site
      • Selangor Darul Ehsan, Malaysia, 68000
        • Novo Nordisk Investigational Site
      • Seremban, Negeri Sembilan, Malaysia, 70400
        • Novo Nordisk Investigational Site
  • South Africa
    • Gauteng
      • Benoni, Gauteng, South Africa, 1501
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 1827
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 1812
        • Novo Nordisk Investigational Site
      • Lenasia, Gauteng, South Africa, 1827
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa, 0181
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Novo Nordisk Investigational Site
      • Durban, KwaZulu-Natal, South Africa, 4092
        • Novo Nordisk Investigational Site
      • Durban, KwaZulu-Natal, South Africa, 4450
        • Novo Nordisk Investigational Site
  • United Arab Emirates
      • Ajman, United Arab Emirates, 21499
        • Novo Nordisk Investigational Site
      • Dubai, United Arab Emirates, 4545
        • Novo Nordisk Investigational Site
      • Dubai, United Arab Emirates, 9115
        • Novo Nordisk Investigational Site
      • Ras Al Khaimah, United Arab Emirates, 4727
        • Novo Nordisk Investigational Site
      • Sharjah, United Arab Emirates, 3500
        • Novo Nordisk Investigational Site
      • Umm Al Quwain, United Arab Emirates, 24
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liraglutide+Metformin
Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
Drug: liraglutide
1.8 mg administered subcutaneously (s.c., under the skin) once daily
Drug: metformin
Subjects will continue on their pre-trial metformin tablet treatment, dose unchanged
Active Comparator: Sulphonylurea and Metformin
Subjects continued on pre-trial sulphonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
Drug: metformin
Subjects will continue on their pre-trial metformin tablet treatment, dose unchanged
Drug: sulphonylurea
Subjects will continue on their pre-trial SU tablet treatment, doses unchanged

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fructosamine From Start of Ramadan to End of Ramadan
Time Frame: Day -1, day 29
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).
Day -1, day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fructosamine at End of Ramadan
Time Frame: Day 29
The fructosamine values at the end of Ramadan (visit 12) were presented
Day 29
Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)
Time Frame: Day -1, day 29
The level of FPG in the blood of fasting patients was addressed to monitor glycaemic control during the period described.
Day -1, day 29
Change From Baseline to End of Ramadan in Fasting Plasma Glucose
Time Frame: Baseline, day 29
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.
Baseline, day 29
Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)
Time Frame: Baseline, day 29
The level of glycosylated haemoglobin in blood was used to assess the glycaemic control of the patients during the time period described.
Baseline, day 29
Change From Baseline to End of Ramadan in Body Weight
Time Frame: Baseline, day 29
Baseline, day 29
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)
Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)
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
Time Frame: Visit 14 (4 weeks post Ramadan)
Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)
Visit 14 (4 weeks post Ramadan)
Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.
Time Frame: Day -1 to day 29
Day -1 to day 29
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

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
Day -1 to day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 4, 2014

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (Estimate)

August 7, 2013

Study Record Updates

Last Update Posted (Actual)

August 24, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-3987
  • U1111-1132-9716 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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