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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01917656
First received: July 29, 2013
Last updated: May 2, 2014
Last verified: May 2014

July 29, 2013
May 2, 2014
January 2014
September 2014   (final data collection date for primary outcome measure)
Change in fructosamine from start of Ramadan to end of Ramadan [ Time Frame: Day -1, day 29 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01917656 on ClinicalTrials.gov Archive Site
  • Fructosamine at end of Ramadan [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
  • 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 ]
  • Change from baseline to end of Ramadan in FPG [ Time Frame: Baseline, day 29 ] [ Designated as safety issue: No ]
  • Change from baseline to end of Ramadan in glycosylated haemoglobin (HbA1c) [ Time Frame: Baseline, day 29 ] [ Designated as safety issue: No ]
  • 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: 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), and no confirmed hypoglycaemic episodes [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
  • Number of confirmed hypoglycaemic episodes [ Time Frame: Day -1 to day 29 ] [ Designated as safety issue: No ]
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: Day -1 to day 29 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes
Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • 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
  • Drug: sulfonylurea
    Subjects will continue on their pre-trial SU tablet treatment, doses unchanged
  • Experimental: Metformin + liraglutide
    Interventions:
    • Drug: liraglutide
    • Drug: metformin
  • Active Comparator: Metformin + SU
    Interventions:
    • Drug: metformin
    • Drug: sulfonylurea
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
320
September 2014
September 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Algeria,   India,   Israel,   Lebanon,   Malaysia,   South Africa,   United Arab Emirates
 
NCT01917656
NN2211-3987, U1111-1132-9716
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP