MedDataX Logo

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

NCT ID: NCT01917656

Last Updated: 2017-08-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-09

Study Completion Date

2014-09-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trial for People With Established Type 2 Diabetes During Ramadan

NCT02292290

Type 2 Diabetes
COMPLETED PHASE4

Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes

NCT00395746

Diabetes Diabetes Mellitus, Type 2
COMPLETED PHASE3

Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

NCT00393718

Diabetes Diabetes Mellitus, Type 2
COMPLETED PHASE3

The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy

NCT01618162

Diabetes Diabetes Mellitus, Type 2
COMPLETED PHASE3

Insulin Glargine During and After the Period of Fasting in Ramadan

NCT00258804

Diabetes Mellitus, Type 2
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Liraglutide+Metformin

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

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

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

metformin

Intervention Type DRUG

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

Sulphonylurea and Metformin

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

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

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

sulphonylurea

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

liraglutide

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

Intervention Type DRUG

metformin

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

Intervention Type DRUG

sulphonylurea

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Algiers, , Algeria

Site Status

Novo Nordisk Investigational Site

Constantine, , Algeria

Site Status

Novo Nordisk Investigational Site

Oran, , Algeria

Site Status

Novo Nordisk Investigational Site

Sétif, , Algeria

Site Status

Novo Nordisk Investigational Site

Sidi Bel Abbes, , Algeria

Site Status

Novo Nordisk Investigational Site

Hyderabad, Andhra Pradesh, India

Site Status

Novo Nordisk Investigational Site

Ahmedabad, Gujarat, India

Site Status

Novo Nordisk Investigational Site

Bangalore, Karnataka, India

Site Status

Novo Nordisk Investigational Site

Mysore, Karnataka, India

Site Status

Novo Nordisk Investigational Site

Mysore, Karnataka, India

Site Status

Novo Nordisk Investigational Site

Mumbai, Maharashtra, India

Site Status

Novo Nordisk Investigational Site

Mumbai, Maharashtra, India

Site Status

Novo Nordisk Investigational Site

Mumbai, Maharashtra, India

Site Status

Novo Nordisk Investigational Site

Pune, Maharashtra, India

Site Status

Novo Nordisk Investigational Site

Beersheba, , Israel

Site Status

Novo Nordisk Investigational Site

Haifa, , Israel

Site Status

Novo Nordisk Investigational Site

Haifa, , Israel

Site Status

Novo Nordisk Investigational Site

Jerusalem, , Israel

Site Status

Novo Nordisk Investigational Site

Beirut, , Lebanon

Site Status

Novo Nordisk Investigational Site

Lebanon - Beirut, , Lebanon

Site Status

Novo Nordisk Investigational Site

Cheras, , Malaysia

Site Status

Novo Nordisk Investigational Site

Ipoh, Perak, , Malaysia

Site Status

Novo Nordisk Investigational Site

Klang, Selangor, , Malaysia

Site Status

Novo Nordisk Investigational Site

Kota Bharu, Kelantan, , Malaysia

Site Status

Novo Nordisk Investigational Site

Putrajaya, , Malaysia

Site Status

Novo Nordisk Investigational Site

Selangor Darul Ehsan, , Malaysia

Site Status

Novo Nordisk Investigational Site

Seremban, Negeri Sembilan, , Malaysia

Site Status

Novo Nordisk Investigational Site

Benoni, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Lenasia, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Pretoria, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Novo Nordisk Investigational Site

Ajman, , United Arab Emirates

Site Status

Novo Nordisk Investigational Site

Dubai, , United Arab Emirates

Site Status

Novo Nordisk Investigational Site

Dubai, , United Arab Emirates

Site Status

Novo Nordisk Investigational Site

Ras al-Khaimah, , United Arab Emirates

Site Status

Novo Nordisk Investigational Site

Sharjah city, , United Arab Emirates

Site Status

Novo Nordisk Investigational Site

Umm Al Quwain City, , United Arab Emirates

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Algeria India Israel Lebanon Malaysia South Africa United Arab Emirates

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 27376711 (View on PubMed)

Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.

Reference Type DERIVED
PMID: 37435938 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1132-9716

Identifier Type: OTHER

Identifier Source: secondary_id

NN2211-3987

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT00318422 COMPLETED PHASE3
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus.
NCT02607306 COMPLETED PHASE3
A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs
NCT02911948 COMPLETED PHASE3
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus
NCT01952145 COMPLETED PHASE3
Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan
NCT02941367 COMPLETED PHASE4
Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart Twice Daily and Biphasic Insulin Aspart Twice Daily in Subjects With Type 2 Diabetes Mellitus Before, During and After Ramadan
NCT02648217 COMPLETED PHASE3
Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes
NCT02128932 COMPLETED PHASE3
Observational Study of Effectiveness and Tolerability of Gliclazide MR 60mg in Diabetic Patients Fasting During RAMADAN
NCT04132934 COMPLETED
Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes
NCT01973231 COMPLETED PHASE4
Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.
NCT02648204 COMPLETED PHASE3
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT00331851 COMPLETED PHASE3
A Study in Patients With Type 2 Diabetes Mellitus
NCT01435616 COMPLETED PHASE3
Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure
NCT01117350 COMPLETED PHASE4
The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification
NCT01664247 COMPLETED PHASE3
Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes
NCT02730377 COMPLETED PHASE4
To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together
NCT00318461 COMPLETED PHASE3
Comparison of Liraglutide and Glimepiride on Blood Sugar Control in Subjects With Type 2 Diabetes
NCT01509755 COMPLETED PHASE2
A Study of Once-Daily NNC0090-2746 in Participants With Type 2 Diabetes Inadequately Controlled With Metformin
NCT02205528 COMPLETED PHASE2
Safety and Tolerability of Insulin Degludec/Liraglutide (A3) in Healthy Subjects
NCT01319240 COMPLETED PHASE1
The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes
NCT00856986 COMPLETED PHASE3
A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes
NCT01794143 COMPLETED PHASE3
LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors.
NCT02964247 COMPLETED PHASE3
Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes
NCT03136484 COMPLETED PHASE3
Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes
NCT00191464 COMPLETED PHASE4
A Trial to Demonstrate Bioequivalence Between Two Insulin Degludec/Liraglutide Formulations, B5 and V2 in Healthy Subjects
NCT01916174 COMPLETED PHASE1