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). |
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Condition | Diabetes Diabetes Mellitus, Type 2 |
Intervention | Drug: liraglutide Drug: metformin Drug: sulfonylurea |
Phase | Phase 4 |
Sponsor | Novo Nordisk A/S |
Responsible Party | Novo Nordisk A/S |
ClinicalTrials.gov Identifier | NCT01917656 |
First Received | July 29, 2013 |
Last Updated | April 9, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | July 29, 2013 |
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Last Updated Date | April 9, 2014 |
Start Date | January 2014 |
Estimated Primary Completion Date | September 2014 |
Current 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] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes |
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Official Title | Efficacy 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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | 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 |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 320 |
Estimated Completion Date | September 2014 |
Estimated Primary Completion Date | September 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) |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Algeria, India, Israel, Lebanon, Malaysia, South Africa, United Arab Emirates |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01917656 |
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Other Study ID Numbers | NN2211-3987 |
Has Data Monitoring Committee | No |
Information Provided By | Novo Nordisk A/S |
Study Sponsor | Novo Nordisk A/S |
Collaborators | Not Provided |
Investigators | Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
Algeria | Oran, Algeria, 31000 |
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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 |