DiabetesPhase 4LIRA-SWITCH™NCT01907854

Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin

A Phase 4 study testing liraglutide and sitagliptin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 106 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 Asia, Europe and North America. The aim of the trial is to investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin. 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 and sitagliptin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 407 participants
Where: 106 sitesin 7 countries
Study dates: 2 Dec 2013to 15 Jun 2015
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

- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Subjects diagnosed with type 2 diabetes and treated with metformin equal to or above 1500 mg/day (or maximum tolerated dose equal to or above 1000 mg/day) and sitagliptin 100 mg/day, both at a stable dose for at least 90 days prior to screening. Stable is defined as unchanged medication and dose
- HbA1c 7.5% - 9.5% (58 mmol/mol - 80 mmol/mol) (both inclusive)
- Body mass index equal to or above 20 kg/m^2

Who cannot join

- Any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol
- Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. An exception is short-term treatment (equal to or less than 7 days in total) with insulin in connection with intercurrent illness
- Female who is pregnant, breast-feeding, intends to become pregnant or of child-bearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulations or practice)
- 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 or multiple endocrine neoplasia syndrome type 2

Show all 12Show fewer

- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
- Impaired liver function, defined as alanine aminotransferase equal to or above 2.5 times upper normal limit
- Impaired renal function defined as estimated glomerular filtration rate 60 mL/min/1.73 m^2 per modification of diet in renal disease formula
- Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
- Heart failure, New York Heart Association class IV
- Uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg)

Trial locations and contacts

106 sites in 7 countries.

Country

City, postcode or hospital

106 sites in 7 countries

United States58 sites

Novo Nordisk Investigational Site
Akron, Ohio, 44311
Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Arlington Heights, Illinois, 60005-4144
Novo Nordisk Investigational Site
Avon, Indiana, 46123
Novo Nordisk Investigational Site
Bangor, Maine, 04401
Novo Nordisk Investigational Site
Berlin, New Jersey, 08009
Novo Nordisk Investigational Site
Blackfoot, Idaho, 83221
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28210
Novo Nordisk Investigational Site
Chicago, Illinois, 60604
Novo Nordisk Investigational Site
Chiefland, Florida, 32626
Novo Nordisk Investigational Site
City of Saint Peters, Missouri, 63376
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80909
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80922
Novo Nordisk Investigational Site
Council Bluffs, Iowa, 51501
Novo Nordisk Investigational Site
Edinburg, Texas, 78539
Novo Nordisk Investigational Site
Elizabeth, New Jersey, 07202
Novo Nordisk Investigational Site
Escondido, California, 92025
Novo Nordisk Investigational Site
Evansville, Indiana, 47714
Novo Nordisk Investigational Site
Evansville, Indiana, 47725
Novo Nordisk Investigational Site
Fall River, Massachusetts, 02720
Novo Nordisk Investigational Site
Fort Lauderdale, Florida, 33308
Novo Nordisk Investigational Site
Fort Worth, Texas, 76104
Novo Nordisk Investigational Site
Hialeah, Florida, 33012
Novo Nordisk Investigational Site
Honolulu, Hawaii, 96814
Novo Nordisk Investigational Site
Houston, Texas, 77024
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Houston, Texas, 77036
Novo Nordisk Investigational Site
Houston, Texas, 77079
Novo Nordisk Investigational Site
Jacksonville, Florida, 32207
Novo Nordisk Investigational Site
Jacksonville, Florida, 32216
Novo Nordisk Investigational Site
Jacksonville, Florida, 32258
Novo Nordisk Investigational Site
Johns Creek, Georgia, 30097
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89119
Novo Nordisk Investigational Site
Memphis, Tennessee, 38119
Novo Nordisk Investigational Site
Miami, Florida, 33183
Novo Nordisk Investigational Site
Midland, Texas, 79707
Novo Nordisk Investigational Site
Mission Viejo, California, 92691
Novo Nordisk Investigational Site
Moncks Corner, South Carolina, 29461
Novo Nordisk Investigational Site
Nashua, New Hampshire, 03063
Novo Nordisk Investigational Site
New Braunfels, Texas, 78130
Novo Nordisk Investigational Site
North Miami, Florida, 33181
Novo Nordisk Investigational Site
North Richland Hills, Texas, 76180
Novo Nordisk Investigational Site
Orangeburg, South Carolina, 29118
Novo Nordisk Investigational Site
Peoria, Illinois, 61602
Novo Nordisk Investigational Site
Phoenix, Arizona, 85018
Novo Nordisk Investigational Site
Phoenix, Arizona, 85027
Novo Nordisk Investigational Site
Port Charlotte, Florida, 33952
Novo Nordisk Investigational Site
Reading, Pennsylvania, 19606
Novo Nordisk Investigational Site
Roseville, California, 95661
Novo Nordisk Investigational Site
Salisbury, North Carolina, 28144
Novo Nordisk Investigational Site
San Antonio, Texas, 78245
Novo Nordisk Investigational Site
Skokie, Illinois, 60077
Novo Nordisk Investigational Site
Spokane, Washington, 99202-3649
Novo Nordisk Investigational Site
Sugar Land, Texas, 77478
Novo Nordisk Investigational Site
Troy, Michigan, 48085-5524
Novo Nordisk Investigational Site
Tucson, Arizona, 85704
Novo Nordisk Investigational Site
Tucson, Arizona, 85724
Novo Nordisk Investigational Site
Virginia Beach, Virginia, 23454

Other trials in United States

Canada17 sites

Novo Nordisk Investigational Site
Brampton, Ontario, L6S 0C6
Novo Nordisk Investigational Site
Burlington, Ontario, L7M 4Y1
Novo Nordisk Investigational Site
Concord, Ontario, L4K 4M2
Novo Nordisk Investigational Site
Drummondville, Quebec, J2B 7T1
Novo Nordisk Investigational Site
Etobicoke, Ontario, M9R 4E1
Novo Nordisk Investigational Site
Grimsby, Ontario, L3M 1P3
Novo Nordisk Investigational Site
Montreal, Quebec, H4A 3T2
Novo Nordisk Investigational Site
Ottawa, Ontario, K1K 4L2
Novo Nordisk Investigational Site
Québec, G3K 2P8
Novo Nordisk Investigational Site
Saint Romuald, Quebec, G6W 5M6
Novo Nordisk Investigational Site
Sarnia, Ontario, N7T 4X3
Novo Nordisk Investigational Site
Strathroy, Ontario, N7G 1Y7
Novo Nordisk Investigational Site
Surrey, British Columbia, V3S 2N6
Novo Nordisk Investigational Site
Toronto, Ontario, M3J 1N2
Novo Nordisk Investigational Site
Toronto, Ontario, M4G 3E8
Novo Nordisk Investigational Site
Toronto, Ontario, M9V 4B4
Novo Nordisk Investigational Site
Trois-Rivières, Quebec, G8T 7A1

Other trials in Canada

Hungary8 sites

Novo Nordisk Investigational Site
Budapest, 1042
Novo Nordisk Investigational Site
Debrecen, 4043
Novo Nordisk Investigational Site
Eger, 3300
Novo Nordisk Investigational Site
Gyula, H-5700
Novo Nordisk Investigational Site
Salgótarján, 3100
Novo Nordisk Investigational Site
Sopron, 9400
Novo Nordisk Investigational Site
Szeged, H-6720
Novo Nordisk Investigational Site
Tatabánya, 2800

Other trials in Hungary

India8 sites

Novo Nordisk Investigational Site
Ahmedabad, Gujarat, 380008
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560002
Novo Nordisk Investigational Site
Gandhinagar, Gujarat, 382428
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500082
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400007
Novo Nordisk Investigational Site
New Delhi, 110060
Novo Nordisk Investigational Site
Pune, Maharashtra, 411040
Novo Nordisk Investigational Site
Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

Israel8 sites

Novo Nordisk Investigational Site
Haifa, 3339419
Novo Nordisk Investigational Site
Haifa, 35152
Novo Nordisk Investigational Site
Herzliya, 46851
Novo Nordisk Investigational Site
Kfar Saba, 44281
Novo Nordisk Investigational Site
Nahariya, 22100
Novo Nordisk Investigational Site
Ofakim, 87520
Novo Nordisk Investigational Site
Tel Aviv, 62038
Novo Nordisk Investigational Site
Tel Aviv, 6937947

Other trials in Israel

Spain6 sites

Novo Nordisk Investigational Site
Badalona, 08916
Novo Nordisk Investigational Site
Ferrol, 15405
Novo Nordisk Investigational Site
Granada, 18003
Novo Nordisk Investigational Site
Málaga, 29006
Novo Nordisk Investigational Site
Sanlúcar de Barrameda, 11540
Novo Nordisk Investigational Site
Seville, 41009

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Puerto Rico1 site

Novo Nordisk Investigational Site
San Juan, 00921

Other trials in Puerto Rico

About this study

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: liraglutide, sitagliptin, placebo
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
Starting dose of 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day is reached. Administered subcutaneously (s.c., under the skin) once daily + metformin tablets (at least 1000 mg/day)
sitagliptinDrug
100 mg/day sitagliptin tablets once-daily + metformin (at least 1000 mg/day)
placeboDrug
Sitagliptin placebo tablets once-daily
placeboDrug
Sitagliptin placebo tablets once-daily

Study groups in NCT01907854
Study group	Role	What they receive
Liraglutide + metformin + sitagliptin placebo	Experimental	Not described Receives: Drug: liraglutide; Drug: placebo
Sitagliptin + metformin + liraglutide placebo	Experimental	Not described Receives: Drug: sitagliptin; Drug: placebo

What is being measured

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

Change in HbA1c (Glycosylated Haemoglobin)
Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM).
Measured: From baseline to week 26

Secondary outcomes (6)

Change in Body Weight
Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: FAS: all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM.
Measured: From baseline to week 26
Change in Fasting Plasma Glucose
Change from baseline in fasting plasma glucose was analysed after 26 weeks of treatment. Missing values were imputed using MMRM.
Measured: From baseline to week 26
Change in Fasting Blood Lipids
Ratio to baseline in fasting blood lipids (total cholesterol, low density lipoprotein [LDL], very low density lipoprotein [VLDL], high density lipoprotein [HDL], triglycerides, and free fatty acids) were analysed after 26 weeks treatment. Missing values were imputed using MMRM. Here we are presenting ratio to baseline data.
Measured: From baseline to week 26
Change in Systolic Blood Pressure and Diastolic Blood Pressure
Change from baseline in systolic and diastolic blood pressure were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.
Measured: From baseline to week 26
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)
Number of subjects who achieve HbA1c <7.0% were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.
Measured: After 26 weeks of treatment
Number of Treatment Emergent Adverse Events (TEAEs)
A treatment emergent adverse event (TEAE) was defined as an event that had an onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. The number of TEAEs was recorded during 26 weeks of treatment plus one week follow-up period.
Measured: During 26 weeks of treatment plus one week follow-up period.

Timeline

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

2 Dec 201315 Jun 2015

First posted25 Jul 2013 (estimated)
Study start2 Dec 2013
Primary completion15 Jun 2015
Study completion15 Jun 2015

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 (1)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: Double blind
Who is masked: Participant, Investigator
Enrolment: 407 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01907854
Sponsor's protocol ID: NN2211-4059
Other IDs: 2012-004931-22, U1111-1136-2073, CTRI/2014/05/004623
Acronym: LIRA-SWITCH™
Status last verified: Sep 2018
First submitted: 22 Jul 2013
Last updated: 2 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bailey TS, Takacs R, Tinahones FJ, Rao PV, Tsoukas GM, Thomsen AB, Kaltoft MS, Maislos M. Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH): a randomized, double-blind, double-dummy, active-controlled 26-week trial. Diabetes Obes Metab. 2016 Dec;18(12):1191-1198. doi: 10.1111/dom.12736. Epub 2016 Sep 14.
PubMed 27381275

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

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Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin
ClinicalTrials.gov ID: NCT01907854
Acronym / sponsor ID: LIRA-SWITCH™ / NN2211-4059
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 407 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 2 Dec 2013 (actual)
Primary completion: 15 Jun 2015 (actual)
Study completion: 15 Jun 2015 (actual)
First posted: 25 Jul 2013 (estimated)
Results: Posted 1 Jul 2016

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Liraglutide + metformin + sitagliptin placebo	Experimental	Drug: liraglutide, Drug: placebo
Sitagliptin + metformin + liraglutide placebo	Experimental	Drug: sitagliptin, Drug: placebo

Who may qualify

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

Key inclusion criteria (4 listed)

- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Subjects diagnosed with type 2 diabetes and treated with metformin equal to or above 1500 mg/day (or maximum tolerated dose equal to or above 1000 mg/day) and sitagliptin 100 mg/day, both at a stable dose for at least 90 days prior to screening. Stable is defined as unchanged medication and dose
- HbA1c 7.5% - 9.5% (58 mmol/mol - 80 mmol/mol) (both inclusive)
- Body mass index equal to or above 20 kg/m^2

Key exclusion criteria (12 listed)

- Any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol
- Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. An exception is short-term treatment (equal to or less than 7 days in total) with insulin in connection with intercurrent illness
- Female who is pregnant, breast-feeding, intends to become pregnant or of child-bearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulations or practice)
- History of chronic pancreatitis or idiopathic acute pancreatitis
- Screening calcitonin value equal to or above 50 ng/L

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
liraglutideStarting dose of 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day is reached. Administered subcutaneously (s.c., under the skin) once daily + metformin tablets (at least 1000 mg/day)	Drug	Liraglutide + metformin + sitagliptin placebo
sitagliptin100 mg/day sitagliptin tablets once-daily + metformin (at least 1000 mg/day)	Drug	Sitagliptin + metformin + liraglutide placebo
placeboSitagliptin placebo tablets once-daily	Drug	Liraglutide + metformin + sitagliptin placebo
placeboSitagliptin placebo tablets once-daily	Drug	Sitagliptin + metformin + liraglutide placebo

Primary outcome

Change in HbA1c (Glycosylated Haemoglobin)
Time frame: From baseline to week 26
Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM).

6 secondary outcomes

Change in Body Weight
Time frame: From baseline to week 26
Change in Fasting Plasma Glucose
Time frame: From baseline to week 26
Change in Fasting Blood Lipids
Time frame: From baseline to week 26
Change in Systolic Blood Pressure and Diastolic Blood Pressure
Time frame: From baseline to week 26
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)
Time frame: After 26 weeks of treatment
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: During 26 weeks of treatment plus one week follow-up period.

Results and safety

Results posted to the registry on 1 Jul 2016, 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	203	187
Sitagliptin	204	191

Primary outcome: Change in HbA1c (Glycosylated Haemoglobin)

Time frame: From baseline to week 26. Mean (Standard Deviation). Unit: percentage of glycosylated haemoglobin

Measure	Liraglutide n = 176	Sitagliptin n = 182
Value	-1.146 (0.9748)	-0.529 (1.0148)

Liraglutide vs Sitagliptin: Treatment difference: -0.61 (95% CI -0.82 to -0.40), p <0.0001, Mixed Models Analysis

Population analysed: Full analysis set (FAS) -All randomised subjects receiving at least one dose of any of the trial product.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 27 weeks (26 weeks of treatment period + 1 week of follow-up). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liraglutide	6 of 202 (3%)	96 of 202 (47.5%)	Not reported
Sitagliptin	7 of 204 (3.4%)	61 of 204 (29.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27381275Bailey TS, Takacs R, Tinahones FJ, Rao PV, Tsoukas GM, Thomsen AB, Kaltoft MS, Maislos M. Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH): a randomized, double-blind, double-dummy, active-controlled 26-week trial. Diabetes Obes Metab. 2016 Dec;18(12):1191-1198. doi: 10.1111/dom.12736. Epub 2016 Sep 14.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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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

106 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 and sitagliptin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 106 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 12 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Canada, Hungary, India, Israel 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 1 Jul 2016). 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 HbA1c (Glycosylated Haemoglobin) (time frame: From baseline to week 26). 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 NCT01907854, which also lists 1 linked publication.

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 2 Oct 2018.