DiabetesPhase 4LIRA-Ramadan™NCT01917656

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

A Phase 4 study testing liraglutide, metformin and sulphonylurea in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 41 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: liraglutide, metformin and sulphonylurea
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 343 participants
Where: 41 sitesin 7 countries
Study dates: 9 Jan 2014to 4 Sep 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

- 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

Who cannot join

- 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)

Show all 9Show fewer

- 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)

Trial locations and contacts

41 sites in 7 countries.

Country

City, postcode or hospital

41 sites in 7 countries

India9 sites

Novo Nordisk Investigational Site
Ahmedabad, Gujarat, 380007
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560002
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500034
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400008
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400010
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400058
Novo Nordisk Investigational Site
Mysore, Karnataka, 570001
Novo Nordisk Investigational Site
Mysore, Karnataka, 570004
Novo Nordisk Investigational Site
Pune, Maharashtra, 411001

Other trials in India

South Africa8 sites

Novo Nordisk Investigational Site
Benoni, Gauteng, 1501
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4091
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4092
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4450
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 1812
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 1827
Novo Nordisk Investigational Site
Lenasia, Gauteng, 1827
Novo Nordisk Investigational Site
Pretoria, Gauteng, 0181

Other trials in South Africa

Malaysia7 sites

Novo Nordisk Investigational Site
Cheras, 56000
Novo Nordisk Investigational Site
Ipoh, Perak, 30990
Novo Nordisk Investigational Site
Klang, Selangor, 41200
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, 16150
Novo Nordisk Investigational Site
Putrajaya, 62250
Novo Nordisk Investigational Site
Selangor Darul Ehsan, 68000
Novo Nordisk Investigational Site
Seremban, Negeri Sembilan, 70400

Other trials in Malaysia

United Arab Emirates6 sites

Novo Nordisk Investigational Site
Ajman, 21499
Novo Nordisk Investigational Site
Dubai, 4545
Novo Nordisk Investigational Site
Dubai, 9115
Novo Nordisk Investigational Site
Ras al-Khaimah, 4727
Novo Nordisk Investigational Site
Sharjah city, 3500
Novo Nordisk Investigational Site
Umm Al Quwain City, 24

Other trials in United Arab Emirates

Algeria5 sites

Novo Nordisk Investigational Site
Algiers, 16000
Novo Nordisk Investigational Site
Constantine, 25000
Novo Nordisk Investigational Site
Oran, 31000
Novo Nordisk Investigational Site
Sétif, 19000
Novo Nordisk Investigational Site
Sidi Bel Abbes, 22000

Other trials in Algeria

Israel4 sites

Novo Nordisk Investigational Site
Beersheba, 84101
Novo Nordisk Investigational Site
Haifa, 31096
Novo Nordisk Investigational Site
Haifa, 35152
Novo Nordisk Investigational Site
Jerusalem, 93106

Other trials in Israel

Lebanon2 sites

Novo Nordisk Investigational Site
Beirut
Novo Nordisk Investigational Site
Lebanon - Beirut, 9611

Other trials in Lebanon

About this study

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: liraglutide, metformin, sulphonylurea
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

liraglutideDrug
1.8 mg administered subcutaneously (s.c., under the skin) once daily
metforminDrug
Subjects will continue on their pre-trial metformin tablet treatment, dose unchanged
sulphonylureaDrug
Subjects will continue on their pre-trial SU tablet treatment, doses unchanged

Study groups in NCT01917656
Study group	Role	What they receive
Liraglutide+Metformin	Experimental	Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose. Receives: Drug: liraglutide; Drug: metformin
Sulphonylurea and Metformin	Active comparator	Subjects continued on pre-trial sulphonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose. Receives: Drug: metformin; Drug: sulphonylurea

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Day -1, day 29

Secondary outcomes (9)

Fructosamine at End of Ramadan
The fructosamine values at the end of Ramadan (visit 12) were presented
Measured: Day 29
Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)
The level of FPG in the blood of fasting patients was addressed to monitor glycaemic control during the period described.
Measured: Day -1, day 29
Change From Baseline to End of Ramadan in Fasting Plasma Glucose
The changes from baseline measured postbaseline (i.e., the changes measured on visit 8 and 12) entered as the dependent variables, and visit, treatment, country, and the stratification variables were included as fixed factors and the corresponding values for the specific endpoint measured at randomisation as covariate.
Measured: Baseline, day 29
Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)
The level of glycosylated haemoglobin in blood was used to assess the glycaemic control of the patients during the time period described.
Measured: Baseline, day 29
Change From Baseline to End of Ramadan in Body Weight
Measured: Baseline, day 29
Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)
Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)
Measured: Visit 14 (4 weeks post Ramadan)
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
Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)
Measured: Visit 14 (4 weeks post Ramadan)
Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.
Measured: Day -1 to day 29
Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.
A serious AE was an experience that at any dose resulted in any of the following: Death, a life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, a persistent or significant disability or incapacity, congenital anomaly or birth defect, important medical events.
Mild - no or transient symptoms, no interference with the subject's daily activities Moderate - marked symptoms, moderate interference with the subject's daily activities Severe - considerable interference with the subject's daily activities, unacceptable
Measured: Day -1 to day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jan 20144 Sep 2014

First posted7 Aug 2013 (estimated)
Study start9 Jan 2014
Primary completion1 Sep 2014
Study completion4 Sep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 343 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01917656
Sponsor's protocol ID: NN2211-3987
Other IDs: U1111-1132-9716
Acronym: LIRA-Ramadan™
Status last verified: Jul 2017
First submitted: 29 Jul 2013
Last updated: 24 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27376711
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.
PubMed 37435938

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT01917656
Acronym / sponsor ID: LIRA-Ramadan™ / NN2211-3987
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 343 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 9 Jan 2014 (actual)
Primary completion: 1 Sep 2014 (actual)
Study completion: 4 Sep 2014 (actual)
First posted: 7 Aug 2013 (estimated)
Results: Posted 7 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Liraglutide+Metformin	Experimental	Drug: liraglutide, Drug: metforminLiraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
Sulphonylurea and Metformin	Active comparator	Drug: metformin, Drug: sulphonylureaSubjects continued on pre-trial sulphonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

- 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

Key exclusion criteria (9 listed)

- 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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
liraglutide1.8 mg administered subcutaneously (s.c., under the skin) once daily	Drug	Liraglutide+Metformin
metforminSubjects will continue on their pre-trial metformin tablet treatment, dose unchanged	Drug	Liraglutide+Metformin, Sulphonylurea and Metformin
sulphonylureaSubjects will continue on their pre-trial SU tablet treatment, doses unchanged	Drug	Sulphonylurea and Metformin

Primary outcome

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

9 secondary outcomes

Fructosamine at End of Ramadan
Time frame: Day 29
Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)
Time frame: Day -1, day 29
Change From Baseline to End of Ramadan in Fasting Plasma Glucose
Time frame: Baseline, day 29
Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)
Time frame: Baseline, day 29
Change From Baseline to End of Ramadan in Body Weight
Time frame: Baseline, day 29
Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)
Time frame: Visit 14 (4 weeks post Ramadan)
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: Visit 14 (4 weeks post Ramadan)
Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.
Time frame: Day -1 to day 29
Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.
Time frame: Day -1 to day 29

Results and safety

Results posted to the registry on 7 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liraglutide and Metformin	172	146
Sulfonylurea and Metformin	171	147

Primary outcome: Change in Fructosamine From Start of Ramadan to End of Ramadan

Time frame: Day -1, day 29. Mean (Standard Deviation). Unit: umol/L

Measure	Liraglutide and Metformin n = 146	Sulfonylurea and Metformin n = 151
Value	-13.2 (36.0)	-14.9 (43.0)

Population analysed: Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: A treatment emergent AE during Ramadan (fasting) had onset on or after the individual subject's first day of Ramadan fasting, and no later than the individual subject's last day of Ramadan fasting.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liraglutide and Metformin	2 of 152 (1.3%)	8 of 152 (5.3%)	Not reported
Sulfonylurea and Metformin	0 of 163 (0%)	1 of 163 (0.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27376711Azar 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.
Derived from this study: PubMed 37435938Lee 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.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

41 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing liraglutide, metformin and sulphonylurea in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 41 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in India, South Africa, Malaysia, United Arab Emirates, Algeria and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fructosamine From Start of Ramadan to End of Ramadan (time frame: Day -1, day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01917656, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.