Type 1 DiabetesPhase 2NCT00768651

Incretin Effect and Use After Clinical Islet Transplantation

A Phase 2 study testing Pantoprazole and Sitagliptin in people with Type 1 Diabetes, run by University of Alberta at 1 site in Canada.

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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Pantoprazole and Sitagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteCanada
Study dates: Oct 2008to Dec 2011
Phase: Phase 2
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must meet the following criteria to be enrolled in this study:
Male or female, aged 18 to 70, inclusive, who is a previous islet transplant recipient (at least 3 months since last islet transplant) and who received their transplant at the University of Alberta.
Insulin independent for 3 months or longer after islet transplant.
Early graft dysfunction as defined by:
HbA1c >6% (but less than 7.5%); or
fasting glucose > 7 mmol/L (126 mg/dl); or

Show all 10Show fewer

random glucose > 10 mmol/L (180 mg/dl), and
Total insulin use of < 10 units/day.
C-peptide positive.
Able to provide informed consent.

Who cannot join

Subjects who meet any of the following criteria will be excluded from the study:
Unable to provide informed consent.
Prior therapy with sitagliptin or a proton pump inhibitor in the preceding 2 months.
Vulnerable populations (i.e. cognitively impaired, pregnant women, residing in institutions, University of Alberta students or employees under the supervision of any of the investigators).
Children, adolescent or patients with a "contraindication" or "warning" listed in the package insert of any of the study drugs:
Hypersensitivity to sitagliptin or pantoprazole for any component of the formulation.

Show all 10Show fewer

Renal disease or renal dysfunction (as suggested by serum creatinine levels ≥ 136 µmol/L (males), ≥ 124 µmol/L (females) or abnormal creatinine clearance; or estimated by Glomerular Filtration Rate (GFR) <50 ml/min/1.73m2).
Acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis).
Uncontrolled hyperglycemia
Any subject that in the opinion of the investigator would not be a good candidate for study participation.

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of Alberta - Clinical Islet Transplant Program
Edmonton, Alberta, T6G2C8

Other trials in Canada

About this study

Official title: Pilot Study of Safety and Efficacy of Combined Use of Dipeptidyl-peptidase Inhibitor (Sitagliptin) and Proton Pump Inhibitor (Pantoprazole) to Prevent Beta-cell Apoptosis and Promote Islet Regeneration in Islet Transplant Recipients With Early Graft Dysfunction

We aim to study if the administration of medications to increase the secretion of hormones from the intestines can improve glycemic control, reduce insulin use and promote β-cell regeneration/expansion in subjects with type 1 diabetes following islet transplantation who are back using small doses of insulin because of early graft dysfunction. We believe that the results will enable us to understand whether these drugs could be useful in islet transplant recipients, particularly if glycemic control deteriorates.

Read the detailed description

This is a single centre non-randomized pilot study. Subjects will be recruited from the current cohort of islet transplant recipients at the University of Alberta.

The primary objective of the study is to evaluate whether the combination of sitagliptin and pantoprazole can restore insulin independence in previously insulin independent islet transplant recipients experiencing early graft dysfunction. The study will also evaluate the safety of the combination drug therapy.

Conditions: Type 1 Diabetes
Being tested: Pantoprazole, Sitagliptin
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

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

PantoprazoleDrug
Also called Pantoloc
Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.
SitagliptinDrug
Also called Januvia
Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months.

Study groups in NCT00768651
Study group	Role	What they receive
One arm: Sitagliptin + Pantoprazole	Experimental	Intervention Details: Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout. Receives: Drug: Pantoprazole; Drug: Sitagliptin

What is being measured

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

The Primary Endpoint Will be Insulin Independence After 6 Months of Therapy.
Insulin independence was defined as no insulin use for at least one week, HbA1c < 6.0%, fasting plasma glucose < 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be >7.8 mmol/l (fasting) or > 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).
Measured: 6 months
Number of Participants Not Using Insulin for at Least One Week After 6 Months of Therapy
Measured: 6 months
Number of Participants With HbA1c < 6.0 % After 6 Months of Therapy
HbA1c was measured using method (manufacturer) at baseline, 3, 6 and 9 months.
Measured: 6 months
Number of Participants With Fasting Plasma Glucose (FPG) < 7 mmol/l After 6 Months of Therapy
Measured: 6 months
Mean Daily Insulin Use (U/Day) After 6 Months of Therapy
Mean daily insulin use was calculated from the three days prior to study visits and performed at baseline, 3, 6, and 9 months.
Measured: 6 months
Change From Baseline of GLP-1 Level After One Month of Therapy
Fasting Glucagon-Like Peptide (GLP-1) levels were measured at baseline and one month. Blood samples were collected in p700 vacutainers (Becton Dickinson, Franklin Lakes, NJ) containing a Dipeptidyl peptidase-4 (DPP4) protease inhibitor cocktail to measure total and active GLP-1 in duplicate using a commercially available ELISA (kit manufacturer) and expressed as the ratio of active:total GLP-1.
Measured: Baseline and One month
Change From Baseline on Gastrin Level After One Month of Therapy
Gastrin levels were measured at baseline and at one month by method (manufacturer).
Measured: Baseline and One month
HbA1c Plasma Laboratory Value for Participants After 6 Months of Therapy
HbA1c was measured at baseline, 3, 6, and 9 months using method (manufacturer.
Measured: 6 months
Acute Insulin Responses to Arginine After 6 Months of Therapy
An intravenous arginine stimulation test (AST) [Ryan:2002cg] was performed at baseline, 6, and 9 months to assess Graft function.
Measured: 6 months
C-peptide Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy
Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.
Measured: 6 months
C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy
Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.
Measured: 6 months
Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy.
Measuring Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.
Measured: 6 months
Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy
Measured: 6 months
Weight Change From Baseline After 6 Months of Therapy
Measuring the weight change from baseline at months: 1, 3, 6 and 9.
Measured: 6 months

Secondary outcomes (8)

Insulin Independence After the 3 Month Washout Period
Insulin independence was defined as no insulin use for at least one week, HbA1c < 6.0%, fasting plasma glucose < 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be >7.8 mmol/l (fasting) or > 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).
Measured: After the 3 month washout period
Insulin Dose (U/Day)
Measured: After the 3 month washout period
Acute Insulin Response to Arginine After the 3 Month Washout Period
An intravenous Arginine stimulation test (AST) [Ryan:2002cg] was performed at baseline, 6, and 9 months to assess Graft function. The Arginine is a proxy for insulin secretory reserve (Robertson:2004br)(Rickels:2007cg) and correlates with islet mass in the context of islet allo-transplant (Ryan:2002cg), auto-transplant (Teuscher:1998eu) and hemipancreatectomy (Seaquist:1992iv). An increase in Arginine (AIRarg) would have suggested an increase in beta cell mass.
Measured: 3 months - washout period
HbA1c Plasma Laboratory Value for Participants After the 3 Month Washout Period
Measuring of HbA1c using method (manufacturer) at baseline, and months: 1, 3, 6, 9.
Measured: After the 3 month washout period
C-peptide Plasma Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) at the End of the 3 Month Washout Period.
Measuring of C-peptide before and 90 minutes after a Mixed Meal Tolerance Test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function. Ther
Measured: After the 3 month washout period
C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.
Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.
Measured: 3 months - washout period
Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.
Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.
Measured: 3 months - washout period
Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period
Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.
Measured: After the 3 month washout period

Timeline

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

Oct 2008Dec 2011

First posted8 Oct 2008 (estimated)
Study startOct 2008
Primary completionJul 2011
Study completionDec 2011

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 Type 1 DiabetesStudies of the same condition, open and under way.
More trials run by University of AlbertaThe 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00768651
Sponsor's protocol ID: 7331
Status last verified: May 2015
First submitted: 7 Oct 2008
Last updated: 18 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Senior PA, Koh A, Yau J, Imes S, Dinyari P, Malcolm AJ, Light P, Shapiro AM. Sitagliptin plus pantoprazole can restore but not maintain insulin independence after clinical islet transplantation: results of a pilot study. Diabet Med. 2017 Feb;34(2):204-212. doi: 10.1111/dme.13131. Epub 2016 May 22.
PubMed 27087519

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 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Safety and Efficacy of Combined Use of Dipeptidyl-peptidase Inhibitor (Sitagliptin) and Proton Pump Inhibitor (Pantoprazole) to Prevent Beta-cell Apoptosis and Promote Islet Regeneration in Islet Transplant Recipients With Early Graft Dysfunction
ClinicalTrials.gov ID: NCT00768651
Acronym / sponsor ID: 7331
Conditions: Type 1 Diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: University of AlbertaUniversity, hospital or other
Collaborators: Juvenile Diabetes Research Foundation
Study start: Oct 2008
Primary completion: Jul 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 8 Oct 2008 (estimated)
Results: Posted 18 Jun 2015

Clinical summary

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

Detailed description

This is a single centre non-randomized pilot study. Subjects will be recruited from the current cohort of islet transplant recipients at the University of Alberta.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
One arm: Sitagliptin + Pantoprazole	Experimental	Drug: Pantoprazole, Drug: SitagliptinIntervention Details: Sitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male or female, aged 18 to 70, inclusive, who is a previous islet transplant recipient (at least 3 months since last islet transplant) and who received their transplant at the University of Alberta.
Insulin independent for 3 months or longer after islet transplant.
Early graft dysfunction as defined by:
C-peptide positive.
Able to provide informed consent.

Key exclusion criteria (10 listed)

Unable to provide informed consent.
Prior therapy with sitagliptin or a proton pump inhibitor in the preceding 2 months.
Vulnerable populations (i.e. cognitively impaired, pregnant women, residing in institutions, University of Alberta students or employees under the supervision of any of the investigators).
Children, adolescent or patients with a "contraindication" or "warning" listed in the package insert of any of the study drugs:
Uncontrolled hyperglycemia

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
PantoprazoleAlso: PantolocStarting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.	Drug	One arm: Sitagliptin + Pantoprazole
SitagliptinAlso: JanuviaStarting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months.	Drug	One arm: Sitagliptin + Pantoprazole

Primary outcome

The Primary Endpoint Will be Insulin Independence After 6 Months of Therapy.
Time frame: 6 months
Insulin independence was defined as no insulin use for at least one week, HbA1c < 6.0%, fasting plasma glucose < 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be >7.8 mmol/l (fasting) or > 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).
Number of Participants Not Using Insulin for at Least One Week After 6 Months of Therapy
Time frame: 6 months
Number of Participants With HbA1c < 6.0 % After 6 Months of Therapy
Time frame: 6 months
HbA1c was measured using method (manufacturer) at baseline, 3, 6 and 9 months.
Number of Participants With Fasting Plasma Glucose (FPG) < 7 mmol/l After 6 Months of Therapy
Time frame: 6 months
Mean Daily Insulin Use (U/Day) After 6 Months of Therapy
Time frame: 6 months
Mean daily insulin use was calculated from the three days prior to study visits and performed at baseline, 3, 6, and 9 months.
Change From Baseline of GLP-1 Level After One Month of Therapy
Time frame: Baseline and One month
Fasting Glucagon-Like Peptide (GLP-1) levels were measured at baseline and one month. Blood samples were collected in p700 vacutainers (Becton Dickinson, Franklin Lakes, NJ) containing a Dipeptidyl peptidase-4 (DPP4) protease inhibitor cocktail to measure total and active GLP-1 in duplicate using a commercially available ELISA (kit manufacturer) and expressed as the ratio of active:total GLP-1.
Change From Baseline on Gastrin Level After One Month of Therapy
Time frame: Baseline and One month
Gastrin levels were measured at baseline and at one month by method (manufacturer).
HbA1c Plasma Laboratory Value for Participants After 6 Months of Therapy
Time frame: 6 months
HbA1c was measured at baseline, 3, 6, and 9 months using method (manufacturer.
Acute Insulin Responses to Arginine After 6 Months of Therapy
Time frame: 6 months
An intravenous arginine stimulation test (AST) [Ryan:2002cg] was performed at baseline, 6, and 9 months to assess Graft function.
C-peptide Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy
Time frame: 6 months
Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.
C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy
Time frame: 6 months
Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.
Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy.
Time frame: 6 months
Measuring Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.
Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy
Time frame: 6 months
Weight Change From Baseline After 6 Months of Therapy
Time frame: 6 months
Measuring the weight change from baseline at months: 1, 3, 6 and 9.

8 secondary outcomes

Insulin Independence After the 3 Month Washout Period
Time frame: After the 3 month washout period
Insulin Dose (U/Day)
Time frame: After the 3 month washout period
Acute Insulin Response to Arginine After the 3 Month Washout Period
Time frame: 3 months - washout period
HbA1c Plasma Laboratory Value for Participants After the 3 Month Washout Period
Time frame: After the 3 month washout period
C-peptide Plasma Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) at the End of the 3 Month Washout Period.
Time frame: After the 3 month washout period
C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.
Time frame: 3 months - washout period
Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.
Time frame: 3 months - washout period
Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period
Time frame: After the 3 month washout period

Results and safety

Results posted to the registry on 18 Jun 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
Sitagliptin + Pantoprazole	8	7

Primary outcome: The Primary Endpoint Will be Insulin Independence After 6 Months of Therapy.

Time frame: 6 months. Number (95% Confidence Interval). Unit: proportion of participants

Measure	One Arm: Sitagliptin + Pantoprazole n = 8
Value	0.25 (-0.06 to 0.56)

One Arm: Sitagliptin + Pantoprazole: p < 0.05, t-test, 2 sided

Population analysed: Per Protocol Set of participants: The participants of subjects in full analysis set who were: compliant with the protocol, compliant with pre-specified exposure to the treatment regimen, and available for measurements of primary variables.

Primary outcome: Number of Participants Not Using Insulin for at Least One Week After 6 Months of Therapy

Time frame: 6 months

The sponsor has not posted figures for this outcome.

Primary outcome: Number of Participants With HbA1c < 6.0 % After 6 Months of Therapy

Time frame: 6 months

The sponsor has not posted figures for this outcome.

Primary outcome: Number of Participants With Fasting Plasma Glucose (FPG) < 7 mmol/l After 6 Months of Therapy

Time frame: 6 months

The sponsor has not posted figures for this outcome.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
One Arm: Sitagliptin + Pantoprazole	0 of 8 (0%)	2 of 8 (25%)	Not reported

Limitations and caveats (from the sponsor): The major weaknesses of the study are the small sample size and the lack of a control group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27087519Senior PA, Koh A, Yau J, Imes S, Dinyari P, Malcolm AJ, Light P, Shapiro AM. Sitagliptin plus pantoprazole can restore but not maintain insulin independence after clinical islet transplantation: results of a pilot study. Diabet Med. 2017 Feb;34(2):204-212. doi: 10.1111/dme.13131. Epub 2016 May 22.

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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.

Peter Senior, MD, PhD principal investigator

University of Alberta

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pantoprazole and Sitagliptin in people with Type 1 Diabetes, run by University of Alberta at 1 site in Canada.

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 10 inclusion and 10 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 18 Jun 2015. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 18 Jun 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?

The Primary Endpoint Will be Insulin Independence After 6 Months of Therapy. (time frame: 6 months). The study lists 14 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 NCT00768651, 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 18 Jun 2015.