Clinical trial NCT01917656: Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-08-07
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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)

Primary outcomes:
measure: Change in Fructosamine From Start of Ramadan to End of Ramadan
timeFrame: Day -1, day 29
Secondary outcomes:
measure: Fructosamine at End of Ramadan
timeFrame: Day 29
measure: Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)
timeFrame: Day -1, day 29
measure: Change From Baseline to End of Ramadan in Fasting Plasma Glucose
timeFrame: Baseline, day 29
measure: Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)
timeFrame: Baseline, day 29
measure: Change From Baseline to End of Ramadan in Body Weight
timeFrame: Baseline, day 29
measure: Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)
timeFrame: Visit 14 (4 weeks post Ramadan)
measure: 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
timeFrame: Visit 14 (4 weeks post Ramadan)
measure: Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.
timeFrame: Day -1 to day 29
measure: Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.
timeFrame: Day -1 to day 29
Other outcomes:
Locations:
city: Algiers
country: Algeria
facility: Novo Nordisk Investigational Site
city: Constantine
country: Algeria
facility: Novo Nordisk Investigational Site
city: Oran
country: Algeria
facility: Novo Nordisk Investigational Site
city: Setif
country: Algeria
facility: Novo Nordisk Investigational Site
city: Sidi Bel Abbes
country: Algeria
facility: Novo Nordisk Investigational Site
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Novo Nordisk Investigational Site
state: Gujarat
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Mysore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Mysore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: Beer Sheva
country: Israel
facility: Novo Nordisk Investigational Site
city: Haifa
country: Israel
facility: Novo Nordisk Investigational Site
city: Haifa
country: Israel
facility: Novo Nordisk Investigational Site
city: Jerusalem
country: Israel
facility: Novo Nordisk Investigational Site
city: Beirut
country: Lebanon
facility: Novo Nordisk Investigational Site
city: Lebanon - Beirut
country: Lebanon
facility: Novo Nordisk Investigational Site
city: Cheras
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Ipoh, Perak
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Klang, Selangor
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Kota Bharu, Kelantan
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Putrajaya
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Selangor Darul Ehsan
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Seremban, Negeri Sembilan
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Benoni
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Lenasia
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Ajman
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Dubai
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Dubai
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Ras Al Khaimah
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Sharjah
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
city: Umm Al Quwain
country: United Arab Emirates
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
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.