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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

343

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Jan 2014

Shorter than P25 for phase_4 diabetes

Geographic Reach

7 countries

41 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

First Submitted

Initial submission to the registry

July 29, 2013

Completed

9 days until next milestone

First Posted

Study publicly available on registry

August 7, 2013

Completed

5 months until next milestone

Study Start

First participant enrolled

January 9, 2014

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed

3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2014

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

October 7, 2015

Completed

Last Updated

August 24, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

July 29, 2013

Results QC Date

September 2, 2015

Last Update Submit

July 25, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Fructosamine From Start of Ramadan to End of Ramadan
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).
Day -1, day 29

Secondary Outcomes (9)

Fructosamine at End of Ramadan
Day 29
Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)
Day -1, day 29
Change From Baseline to End of Ramadan in Fasting Plasma Glucose
Baseline, day 29
Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)
Baseline, day 29
Change From Baseline to End of Ramadan in Body Weight
Baseline, day 29
+4 more secondary outcomes

Study Arms (2)

Liraglutide+Metformin

EXPERIMENTAL

Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.

Drug: liraglutideDrug: metformin

Sulphonylurea and Metformin

ACTIVE COMPARATOR

Subjects continued on pre-trial sulphonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.

Drug: metforminDrug: sulphonylurea

Interventions

liraglutideDRUG

1.8 mg administered subcutaneously (s.c., under the skin) once daily

Liraglutide+Metformin

metforminDRUG

Subjects will continue on their pre-trial metformin tablet treatment, dose unchanged

Liraglutide+MetforminSulphonylurea and Metformin

sulphonylureaDRUG

Subjects will continue on their pre-trial SU tablet treatment, doses unchanged

Sulphonylurea and Metformin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

\- 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

You may not qualify if:

\- 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)

Contact the study team to confirm eligibility.