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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
liraglutide
metformin
sulphonylurea
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liraglutide+Metformin

Sulphonylurea and Metformin

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Fructosamine From Start of Ramadan to End of Ramadan
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 Outcome Measures

Fructosamine at End of Ramadan
The fructosamine values at the end of Ramadan (visit 12) were presented
Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)
The level of FPG in the blood of fasting patients was addressed to monitor glycaemic control during the period described.
Change From Baseline to End of Ramadan in Fasting Plasma Glucose
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.
Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)
The level of glycosylated haemoglobin in blood was used to assess the glycaemic control of the patients during the time period described.
Change From Baseline to End of Ramadan in Body Weight
Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)
Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)
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
Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)
Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.
Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.
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

Full Information

First Posted
July 29, 2013
Last Updated
July 25, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01917656
Brief Title
Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes
Acronym
LIRA-Ramadan™
Official Title
Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 9, 2014 (Actual)
Primary Completion Date
September 1, 2014 (Actual)
Study Completion Date
September 4, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
343 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide+Metformin
Arm Type
Experimental
Arm Description
Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
Arm Title
Sulphonylurea and Metformin
Arm Type
Active Comparator
Arm Description
Subjects continued on pre-trial sulphonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
1.8 mg administered subcutaneously (s.c., under the skin) once daily
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
Subjects will continue on their pre-trial metformin tablet treatment, dose unchanged
Intervention Type
Drug
Intervention Name(s)
sulphonylurea
Intervention Description
Subjects will continue on their pre-trial SU tablet treatment, doses unchanged
Primary Outcome Measure Information:
Title
Change in Fructosamine From Start of Ramadan to End of Ramadan
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).
Time Frame
Day -1, day 29
Secondary Outcome Measure Information:
Title
Fructosamine at End of Ramadan
Description
The fructosamine values at the end of Ramadan (visit 12) were presented
Time Frame
Day 29
Title
Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)
Description
The level of FPG in the blood of fasting patients was addressed to monitor glycaemic control during the period described.
Time Frame
Day -1, day 29
Title
Change From Baseline to End of Ramadan in Fasting Plasma Glucose
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.
Time Frame
Baseline, day 29
Title
Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)
Description
The level of glycosylated haemoglobin in blood was used to assess the glycaemic control of the patients during the time period described.
Time Frame
Baseline, day 29
Title
Change From Baseline to End of Ramadan in Body Weight
Time Frame
Baseline, day 29
Title
Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)
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)
Time Frame
Visit 14 (4 weeks post Ramadan)
Title
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
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)
Time Frame
Visit 14 (4 weeks post Ramadan)
Title
Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.
Time Frame
Day -1 to day 29
Title
Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.
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
Time Frame
Day -1 to day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Algiers
ZIP/Postal Code
16000
Country
Algeria
Facility Name
Novo Nordisk Investigational Site
City
Constantine
ZIP/Postal Code
25000
Country
Algeria
Facility Name
Novo Nordisk Investigational Site
City
Oran
ZIP/Postal Code
31000
Country
Algeria
Facility Name
Novo Nordisk Investigational Site
City
Setif
ZIP/Postal Code
19000
Country
Algeria
Facility Name
Novo Nordisk Investigational Site
City
Sidi Bel Abbes
ZIP/Postal Code
22000
Country
Algeria
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380007
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570004
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400008
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400058
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Haifa
ZIP/Postal Code
35152
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Jerusalem
ZIP/Postal Code
93106
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Beirut
Country
Lebanon
Facility Name
Novo Nordisk Investigational Site
City
Lebanon - Beirut
ZIP/Postal Code
9611
Country
Lebanon
Facility Name
Novo Nordisk Investigational Site
City
Cheras
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Ipoh, Perak
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Klang, Selangor
ZIP/Postal Code
41200
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Kota Bharu, Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Selangor Darul Ehsan
ZIP/Postal Code
68000
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Seremban, Negeri Sembilan
ZIP/Postal Code
70400
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Benoni
State/Province
Gauteng
ZIP/Postal Code
1501
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1812
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1827
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Lenasia
State/Province
Gauteng
ZIP/Postal Code
1827
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4092
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4450
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Ajman
ZIP/Postal Code
21499
Country
United Arab Emirates
Facility Name
Novo Nordisk Investigational Site
City
Dubai
ZIP/Postal Code
4545
Country
United Arab Emirates
Facility Name
Novo Nordisk Investigational Site
City
Dubai
ZIP/Postal Code
9115
Country
United Arab Emirates
Facility Name
Novo Nordisk Investigational Site
City
Ras Al Khaimah
ZIP/Postal Code
4727
Country
United Arab Emirates
Facility Name
Novo Nordisk Investigational Site
City
Sharjah
ZIP/Postal Code
3500
Country
United Arab Emirates
Facility Name
Novo Nordisk Investigational Site
City
Umm Al Quwain
ZIP/Postal Code
24
Country
United Arab Emirates

12. IPD Sharing Statement

Citations:
PubMed Identifier
27376711
Citation
Azar ST, Echtay A, Wan Bebakar WM, Al Araj S, Berrah A, Omar M, Mutha A, Tornoe K, Kaltoft MS, Shehadeh N. Efficacy and safety of liraglutide compared to sulphonylurea during Ramadan in patients with type 2 diabetes (LIRA-Ramadan): a randomized trial. Diabetes Obes Metab. 2016 Oct;18(10):1025-33. doi: 10.1111/dom.12733. Epub 2016 Aug 18.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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