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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01917656
First received: July 29, 2013
Last updated: November 10, 2015
Last verified: November 2015
  Purpose
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).

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide
Drug: metformin
Drug: sulfonylurea
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in Fructosamine From Start of Ramadan to End of Ramadan [ Time Frame: Day -1, day 29 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Day -1, day 29 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, day 29 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, day 29 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, day 29 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Visit 14 (4 weeks post Ramadan) ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day -1 to day 29 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

    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



Enrollment: 343
Study Start Date: January 2014
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Sulfonylurea and Metformin
Subjects continued on pre-trial sulfonylurea 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: sulfonylurea
Subjects will continue on their pre-trial SU tablet treatment, doses unchanged

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917656

Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01917656     History of Changes
Other Study ID Numbers: NN2211-3987  U1111-1132-9716 
Study First Received: July 29, 2013
Results First Received: September 2, 2015
Last Updated: November 10, 2015
Health Authority: Algeria: Ministry of Health
India: Drugs Controller General of India
Israel: Ministry of Health
Lebanon: Ministry of Public Health
Malaysia: Ministry of Health
South Africa: Medicines Control Council
United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Liraglutide
Metformin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 30, 2016