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

Overview[ - collapse ][ - ]

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).
ConditionDiabetes
Diabetes Mellitus, Type 2
InterventionDrug: liraglutide
Drug: metformin
Drug: sulfonylurea
PhasePhase 4
SponsorNovo Nordisk A/S
Responsible PartyNovo Nordisk A/S
ClinicalTrials.gov IdentifierNCT01917656
First ReceivedJuly 29, 2013
Last UpdatedApril 9, 2014
Last verifiedApril 2014

Tracking Information[ + expand ][ + ]

First Received DateJuly 29, 2013
Last Updated DateApril 9, 2014
Start DateJanuary 2014
Estimated Primary Completion DateSeptember 2014
Current Primary Outcome MeasuresChange in fructosamine from start of Ramadan to end of Ramadan [Time Frame: Day -1, day 29] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • 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]

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes
Official TitleEfficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes
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).
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Diabetes
  • Diabetes Mellitus, Type 2
InterventionDrug: 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
Study Arm (s)
  • Experimental: Metformin + liraglutide
  • Active Comparator: Metformin + SU

Recruitment Information[ + expand ][ + ]

Recruitment StatusActive, not recruiting
Estimated Enrollment320
Estimated Completion DateSeptember 2014
Estimated Primary Completion DateSeptember 2014
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)
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesAlgeria, India, Israel, Lebanon, Malaysia, South Africa, United Arab Emirates

Administrative Information[ + expand ][ + ]

NCT Number NCT01917656
Other Study ID NumbersNN2211-3987
Has Data Monitoring CommitteeNo
Information Provided ByNovo Nordisk A/S
Study SponsorNovo Nordisk A/S
CollaboratorsNot Provided
Investigators Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Verification DateApril 2014

Locations[ + expand ][ + ]

Algeria
Oran, Algeria, 31000
India, Gujarat
Ahmedabad, Gujarat, India, 380007
Israel
Haifa, Israel, 31096
Lebanon
Beirut, Lebanon
Malaysia
Putrajaya, Malaysia, 62250
South Africa, Gauteng
Johannesburg, Gauteng, South Africa, 1827
United Arab Emirates
Sharjah, United Arab Emirates, 3500