Coronary Artery DiseasePhase 4AddHope2NCT01595789

The Effect of Liraglutide on the Treatment of Coronary Artery Disease and Type 2 Diabetes

A Phase 4 study testing Liraglutide in people with Coronary Artery Disease and Diabetes Mellitus, Type 2, run by Haugaard, Steen Bendix, M.D., DMSc at 1 site in Denmark.

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

The purpose of this study is to investigate the effect of combined glucagon-like-peptide-1 (GLP-1) analogue and metformin therapy on glucose metabolic and cardiovascular endpoints compared to metformin monotherapy in patients with coronary artery disease (CAD) and newly diagnosed type 2 diabetes (T2D). Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Coronary Artery Disease, Diabetes Mellitus, Type 2
What is being tested?: Liraglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 1 siteDenmark
Study dates: May 2012to Jul 2015
Phase: Phase 4
Are there results?: None posted in the registry

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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Stable CAD documented by one of the following:
Previous MI (a minimum of 6 weeks after an acute MI)
Previous coronary revascularization
CAD confirmed by an abnormal coronary angiography (CAG) or CT-angiography showing stenosis > 50% of any major coronary arteries.
Body mass index (BMI) >/= 25,0 kg/m2
Age >/= 18 years and </= 85 years

Show all 11Show fewer

Type 2 diabetes diagnosed by one of the following criteria:
HbA1c >/= 6.5%
HbA1c < 6.5 % and fasting plasma glucose >/= 7.0 mmol/l (confirmed)
HbA1c < 6.5 % and a 2 h plasma glucose value during OGTT >/= 11.1 mmol/l
The data for glucose metabolism are accepted provided that they have been obtained within 24 months prior to inclusion of the patient. The glucose metabolic categories are defined by ADA and WHO criteria.

Who cannot join

Type 1 diabetes mellitus defined as C-peptide < 450 pM
Previously diagnosed diabetes mellitus for more than 24 months prior to the screening procedure for this trial, except from gestational diabetes
Use of more than 2 types of oral antidiabetic medication and/or use of parenteral antidiabetic medication in the period of 3 months prior to the screening visit. It is accepted that the patient continues his usual antidiabetic medication after the screening visit but antidiabetic medication must be discontinued 2 weeks prior to the baseline visit.
Significant heart disease (NYHA > 2; Ejection Fraction < 40% and unstable angina pectoris) and known severe valve disease
Documented atrial fibrillation or atrial flutter within 6 weeks previous to the screening. Paroxysmal atrial fibrillation is accepted if sinus rhythm is achieved at the screening.
Uncontrolled arterial hypertension (> 180/100 mmHg) at the time of screening

Show all 25Show fewer

Liver (transaminases greater than x 2 the upper normal level) or renal diseases (eGFR < 60 ml/min)
Amylase greater than x 3 the upper reference value
Any chronic medical condition to unduly increase risk for the potential enrollee as judged by study investigators
Dysregulated myxedema or hyperthyroid condition defined by a value of TSH < 0,1 and > 10,0 milli U/L
Anemia (< 85% of lower normal limit), leucopenia (< 85% of lower normal limit), or thrombocytopenia (< 85% of lower normal limit)
Pregnancy or failure to comply with contraception planning within two years, or breastfeeding
Abuse of alcohol or drugs, or any other co-existing condition that would make patients unsuitable to participate in the study, as judged by the investigators
Use of immunosuppressive therapy in the preceding 12 months
Chronic pancreatitis or previous acute pancreatitis
Known or suspected hypersensitivity to trial product(s) or related products
Treatment with oral glucocorticoids, calcineurin inhibitors, or dipeptidyl peptidase 4 (DPP4) inhibitors, or other GLP-1 mimetics (e.g. exenatide), which in the Investigator's opinion could interfere with glucose metabolism
Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, which in the Investigator's opinion could interfere with the results of the trail
Inflammatory bowel disease
Previous bowel resection
Clinical signs of diabetic gastroparesis
Plasma calcium-ion >/= 1,45 mmol/L
Plasma calcitonin >/= 50 ng/L
Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2
Refusal to sign informed consent.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Copenhagen University Hospital, Bispebjerg
Copenhagen, Bispebjerg, 2400

Other trials in Denmark

About this study

Official title: Adding Liraglutide to the Backbone Therapy of Biguanide in Patients With Coronary Artery Disease and Newly Diagnosed Type-2 Diabetes

It is hypothesized that GLP-1 analogue added to backbone therapy of metformin in CAD patients with T2D will improve beta-cell function, left ventricular ejection fraction (LVEF), heart rate variability and lower 24h blood pressure among other selected endpoints.

The present study on CAD patients with newly diagnosed T2D will address these selected endpoints during an investigator initiated, randomized, double blind, crossover, placebo-controlled 12 + 12 weeks intervention study with a 2 week wash-out period.

Read the detailed description

The total study period for each patient will be 26 weeks (12 plus 12 weeks of intervention with a 2 week wash-out period).

The endpoints will be evaluated at baseline (week 0), at week 12, at week 14 (following 2 weeks of wash-out) and finally at week 26.

Conditions: Coronary Artery Disease, Diabetes Mellitus, Type 2
Being tested: Liraglutide, Placebo
Keywords: Coronary Artery Disease, Diabetes Mellitus, Left ventricular ejection fraction, Beta-cell function
Medical subject headings: Coronary Artery Disease, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

LiraglutideDrug
Also called Brand name: Victoza, Active substance: liraglutide, EMA Product number: EMEA/H/C/001026, ATC Code: A10BX07
Liraglutide injection pen is administered by the participant once daily by subcutaneous injection. It is given independent of meals. The starting dose is 0.6 mg. After 2 weeks the dose will be increased to 1.2 mg. The dose will be further increased after 4 weeks to 1.8 mg. After a total of 12 weeks of treatment, a wash-out period of 2 weeks follows. Subsequently, the participant will be crossed over to a second period of 12 weeks of treatment with placebo.
PlaceboDrug
Volume-matched placebo injection pen is administered by the participant once daily by subcutaneous injection. It is given independent of meals. The starting dose is 0.6 mg volume-matched placebo. After 2 weeks the dose will be increased to 1.2 mg. The dose will be further increased after 4 weeks to 1.8 mg. After a total of 12 weeks of treatment, a wash-out period of 2 weeks follows. Subsequently, the participant will be crossed over to a second period of 12 weeks of treatment with liraglutide.

Study groups in NCT01595789
Study group	Role	What they receive
Placebo + metformin	Placebo comparator	Not described Receives: Drug: Placebo
Liraglutide + metformin	Active comparator	Not described Receives: Drug: Liraglutide

What is being measured

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

Beta-cell function
Beta-cell function (disposition index) as measured during an intravenous glucose tolerance test (By Bergman Minimal Model)
Measured: after 12 weeks of intervention
LVEF
Changes in LVEF assessed by dobutamine stress echocardiography
Measured: after 12 weeks of intervention

Secondary outcomes (10)

Glucagon, incretin, glucose, NEFA, insulin and C-peptide response during meal test
Measured: Baseline (week 0), week 12, week 14, week 26
Insulin sensitivity (Si), acute insulin and C-peptide response to intravenous glucose (AIRg, ACRg), glucose clearance (Kg), glucose effectiveness (Sg) and hepatic extraction of insulin (HEXi)
Insulin sensitivity (Si), acute insulin and C-peptide response to intravenous glucose (AIRg, ACRg), glucose clearance (Kg), glucose effectiveness (Sg) and hepatic extraction of insulin (HEXi) derived from a standard frequent sampling intravenous glucose tolerance test (FSIGT, Minimal model)
Measured: Baseline (week 0), week 12, week 14, week 26
CRP, TNF-alfa and IL-6 in plasma and gene expression of IL6 and TNF-alfa in subcutaneous fat
Measured: Baseline (week 0), week 12, week 14, week 26
Non esterified fatty acids (NEFA)
NEFA during FSIGT by use of NEFA minimal model
Measured: Baseline (week 0), week 12, week 14, week 26
Heart rate variability (HRV)
HRV i.e. SDNN (standard deviation of all normal RR interval) assessed during HOLTER monitoring
Measured: Baseline (week 0), week 12, week 14, week 26
Maximal velocity of the myocardium in systole (s´) and in diastole (e´)
Maximal velocity of the myocardium in systole (s´) and in diastole (e´) during the dobutamine stress test
Measured: Baseline (week 0), week 12, week 14, week 26
Changes in exercise tolerance test variables: Total exercise duration (sec), time to limiting angina (sec) and time to 1 mm ST-segment depression (sec)
Changes in exercise tolerance test variables: Total exercise duration (sec), time to limiting angina (sec) and time to 1 mm ST-segment depression (sec)
Measured: Baseline (week 0), week 12, week 14, week 26
ST-depression and ectopic activity
ST-depression and ectopic activity assessed during 24h HOLTER monitoring
Measured: Baseline (week 0), week 12, week 14, week 26
Diurnal blood pressure
Measured: Baseline (week 0), week 12, week 14, week 26
Diastolic heart function (E/E*)
Diastolic heart function (E/E*) in rest and during stress
Measured: Baseline (week 0), week 12, week 14, week 26

Timeline

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

May 2012Jul 2015

First posted10 May 2012 (estimated)
Study startMay 2012
Primary completionOct 2014
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
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: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01595789
Sponsor's protocol ID: BBHAH-2011430
Other IDs: 2011-005405-78
Acronym: AddHope2
Status last verified: Mar 2017
First submitted: 8 May 2012
Last updated: 7 Mar 2017
Results posted: No
Data monitoring committee: Yes

Publications

Kumarathurai P, Sajadieh A, Anholm C, Kristiansen OP, Haugaard SB, Nielsen OW. Effects of liraglutide on diastolic function parameters in patients with type 2 diabetes and coronary artery disease: a randomized crossover study. Cardiovasc Diabetol. 2021 Jan 7;20(1):12. doi: 10.1186/s12933-020-01205-2.
PubMed 33413428
Anholm C, Kumarathurai P, Jurs A, Pedersen LR, Nielsen OW, Kristiansen OP, Fenger M, Holst JJ, Madsbad S, Sajadieh A, Haugaard SB. Liraglutide improves the beta-cell function without increasing insulin secretion during a mixed meal in patients, who exhibit well-controlled type 2 diabetes and coronary artery disease. Diabetol Metab Syndr. 2019 May 31;11:42. doi: 10.1186/s13098-019-0438-6. eCollection 2019.
PubMed 31164926
Kumarathurai P, Anholm C, Fabricius-Bjerre A, Nielsen OW, Kristiansen O, Madsbad S, Haugaard SB, Sajadieh A. Effects of the glucagon-like peptide-1 receptor agonist liraglutide on 24-h ambulatory blood pressure in patients with type 2 diabetes and stable coronary artery disease: a randomized, double-blind, placebo-controlled, crossover study. J Hypertens. 2017 May;35(5):1070-1078. doi: 10.1097/HJH.0000000000001275.
PubMed 28129251
Kumarathurai P, Anholm C, Larsen BS, Olsen RH, Madsbad S, Kristiansen O, Nielsen OW, Haugaard SB, Sajadieh A. Effects of Liraglutide on Heart Rate and Heart Rate Variability: A Randomized, Double-Blind, Placebo-Controlled Crossover Study. Diabetes Care. 2017 Jan;40(1):117-124. doi: 10.2337/dc16-1580. Epub 2016 Oct 19.
PubMed 27797930
Kumarathurai P, Anholm C, Nielsen OW, Kristiansen OP, Molvig J, Madsbad S, Haugaard SB, Sajadieh A. Effects of the glucagon-like peptide-1 receptor agonist liraglutide on systolic function in patients with coronary artery disease and type 2 diabetes: a randomized double-blind placebo-controlled crossover study. Cardiovasc Diabetol. 2016 Jul 26;15(1):105. doi: 10.1186/s12933-016-0425-2.
PubMed 27455835
Anholm C, Kumarathurai P, Klit MS, Kristiansen OP, Nielsen OW, Ladelund S, Madsbad S, Sajadieh A, Haugaard SB; AddHope2 Trial Study Group. Adding liraglutide to the backbone therapy of biguanide in patients with coronary artery disease and newly diagnosed type-2 diabetes (the AddHope2 study): a randomised controlled study protocol. BMJ Open. 2014 Jul 16;4(7):e005942. doi: 10.1136/bmjopen-2014-005942.
PubMed 25031198

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?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adding Liraglutide to the Backbone Therapy of Biguanide in Patients With Coronary Artery Disease and Newly Diagnosed Type-2 Diabetes
ClinicalTrials.gov ID: NCT01595789
Acronym / sponsor ID: AddHope2 / BBHAH-2011430
Conditions: Coronary Artery Disease, Diabetes Mellitus, Type 2
Keywords: Coronary Artery Disease, Diabetes Mellitus, Left ventricular ejection fraction, Beta-cell function
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Haugaard, Steen Bendix, M.D., DMSc
Study start: May 2012
Primary completion: Oct 2014 (actual)
Study completion: Jul 2015 (actual)
First posted: 10 May 2012 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

The total study period for each patient will be 26 weeks (12 plus 12 weeks of intervention with a 2 week wash-out period).

The endpoints will be evaluated at baseline (week 0), at week 12, at week 14 (following 2 weeks of wash-out) and finally at week 26.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo + metformin	Placebo comparator	Drug: Placebo
Liraglutide + metformin	Active comparator	Drug: Liraglutide

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Stable CAD documented by one of the following:
Body mass index (BMI) >/= 25,0 kg/m2
Age >/= 18 years and </= 85 years
Type 2 diabetes diagnosed by one of the following criteria:
The data for glucose metabolism are accepted provided that they have been obtained within 24 months prior to inclusion of the patient. The glucose metabolic categories are defined by ADA and WHO criteria.

Key exclusion criteria (25 listed)

Type 1 diabetes mellitus defined as C-peptide < 450 pM
Previously diagnosed diabetes mellitus for more than 24 months prior to the screening procedure for this trial, except from gestational diabetes
Use of more than 2 types of oral antidiabetic medication and/or use of parenteral antidiabetic medication in the period of 3 months prior to the screening visit. It is accepted that the patient continues his usual antidiabetic medication after the screening visit but antidiabetic medication must be discontinued 2 weeks prior to the baseline visit.
Significant heart disease (NYHA > 2; Ejection Fraction < 40% and unstable angina pectoris) and known severe valve disease
Documented atrial fibrillation or atrial flutter within 6 weeks previous to the screening. Paroxysmal atrial fibrillation is accepted if sinus rhythm is achieved at the screening.

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
LiraglutideAlso: Brand name: Victoza, Active substance: liraglutide, EMA Product number: EMEA/H/C/001026, ATC Code: A10BX07Liraglutide injection pen is administered by the participant once daily by subcutaneous injection. It is given independent of meals. The starting dose is 0.6 mg. After 2 weeks the dose will be increased to 1.2 mg. The dose will be further increased after 4 weeks to 1.8 mg. After a total of 12 weeks of treatment, a wash-out period of 2 weeks follows. Subsequently, the participant will be crossed over to a second period of 12 weeks of treatment with placebo.	Drug	Liraglutide + metformin
PlaceboVolume-matched placebo injection pen is administered by the participant once daily by subcutaneous injection. It is given independent of meals. The starting dose is 0.6 mg volume-matched placebo. After 2 weeks the dose will be increased to 1.2 mg. The dose will be further increased after 4 weeks to 1.8 mg. After a total of 12 weeks of treatment, a wash-out period of 2 weeks follows. Subsequently, the participant will be crossed over to a second period of 12 weeks of treatment with liraglutide.	Drug	Placebo + metformin

Primary outcome

Beta-cell function
Time frame: after 12 weeks of intervention
Beta-cell function (disposition index) as measured during an intravenous glucose tolerance test (By Bergman Minimal Model)
LVEF
Time frame: after 12 weeks of intervention
Changes in LVEF assessed by dobutamine stress echocardiography

10 secondary outcomes

Glucagon, incretin, glucose, NEFA, insulin and C-peptide response during meal test
Time frame: Baseline (week 0), week 12, week 14, week 26
Insulin sensitivity (Si), acute insulin and C-peptide response to intravenous glucose (AIRg, ACRg), glucose clearance (Kg), glucose effectiveness (Sg) and hepatic extraction of insulin (HEXi)
Time frame: Baseline (week 0), week 12, week 14, week 26
CRP, TNF-alfa and IL-6 in plasma and gene expression of IL6 and TNF-alfa in subcutaneous fat
Time frame: Baseline (week 0), week 12, week 14, week 26
Non esterified fatty acids (NEFA)
Time frame: Baseline (week 0), week 12, week 14, week 26
Heart rate variability (HRV)
Time frame: Baseline (week 0), week 12, week 14, week 26
Maximal velocity of the myocardium in systole (s´) and in diastole (e´)
Time frame: Baseline (week 0), week 12, week 14, week 26
Changes in exercise tolerance test variables: Total exercise duration (sec), time to limiting angina (sec) and time to 1 mm ST-segment depression (sec)
Time frame: Baseline (week 0), week 12, week 14, week 26
ST-depression and ectopic activity
Time frame: Baseline (week 0), week 12, week 14, week 26
Diurnal blood pressure
Time frame: Baseline (week 0), week 12, week 14, week 26
Diastolic heart function (E/E*)
Time frame: Baseline (week 0), week 12, week 14, week 26

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
Derived from this study: PubMed 33413428Kumarathurai P, Sajadieh A, Anholm C, Kristiansen OP, Haugaard SB, Nielsen OW. Effects of liraglutide on diastolic function parameters in patients with type 2 diabetes and coronary artery disease: a randomized crossover study. Cardiovasc Diabetol. 2021 Jan 7;20(1):12. doi: 10.1186/s12933-020-01205-2.
Derived from this study: PubMed 31164926Anholm C, Kumarathurai P, Jurs A, Pedersen LR, Nielsen OW, Kristiansen OP, Fenger M, Holst JJ, Madsbad S, Sajadieh A, Haugaard SB. Liraglutide improves the beta-cell function without increasing insulin secretion during a mixed meal in patients, who exhibit well-controlled type 2 diabetes and coronary artery disease. Diabetol Metab Syndr. 2019 May 31;11:42. doi: 10.1186/s13098-019-0438-6. eCollection 2019.
Derived from this study: PubMed 28129251Kumarathurai P, Anholm C, Fabricius-Bjerre A, Nielsen OW, Kristiansen O, Madsbad S, Haugaard SB, Sajadieh A. Effects of the glucagon-like peptide-1 receptor agonist liraglutide on 24-h ambulatory blood pressure in patients with type 2 diabetes and stable coronary artery disease: a randomized, double-blind, placebo-controlled, crossover study. J Hypertens. 2017 May;35(5):1070-1078. doi: 10.1097/HJH.0000000000001275.
Derived from this study: PubMed 27797930Kumarathurai P, Anholm C, Larsen BS, Olsen RH, Madsbad S, Kristiansen O, Nielsen OW, Haugaard SB, Sajadieh A. Effects of Liraglutide on Heart Rate and Heart Rate Variability: A Randomized, Double-Blind, Placebo-Controlled Crossover Study. Diabetes Care. 2017 Jan;40(1):117-124. doi: 10.2337/dc16-1580. Epub 2016 Oct 19.
Derived from this study: PubMed 27455835Kumarathurai P, Anholm C, Nielsen OW, Kristiansen OP, Molvig J, Madsbad S, Haugaard SB, Sajadieh A. Effects of the glucagon-like peptide-1 receptor agonist liraglutide on systolic function in patients with coronary artery disease and type 2 diabetes: a randomized double-blind placebo-controlled crossover study. Cardiovasc Diabetol. 2016 Jul 26;15(1):105. doi: 10.1186/s12933-016-0425-2.
Derived from this study: PubMed 25031198Anholm C, Kumarathurai P, Klit MS, Kristiansen OP, Nielsen OW, Ladelund S, Madsbad S, Sajadieh A, Haugaard SB; AddHope2 Trial Study Group. Adding liraglutide to the backbone therapy of biguanide in patients with coronary artery disease and newly diagnosed type-2 diabetes (the AddHope2 study): a randomised controlled study protocol. BMJ Open. 2014 Jul 16;4(7):e005942. doi: 10.1136/bmjopen-2014-005942.

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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.

Steen B Haugaard, M.D., DMSc study director

Amager Hospital

Ahmad Sajadieh, M.D., DMSc principal investigator

University Hospital Bispebjerg and Frederiksberg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liraglutide in people with Coronary Artery Disease and Diabetes Mellitus, Type 2, run by Haugaard, Steen Bendix, M.D., DMSc at 1 site in Denmark.

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 11 inclusion and 25 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 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Beta-cell function (time frame: after 12 weeks of intervention). The study lists 2 primary outcomes in all. 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 NCT01595789, which also lists 6 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 7 Mar 2017.