HyperglycemiaPhase 2TIPNCT00830297
Treat-to-target Trial of Basal Insulin in Post-transplant Hyperglycemia
A Phase 2 study testing Insulatard (long-acting insulin) and Conventional in people with Hyperglycemia, run by Marcus Saemann at 1 site in Austria.
Trial summary
Treat-to-target trial of basal Insulin in Post-transplant hyperglycemia (TIP): efficacy and safety of a novel protocol in renal transplant recipients receiving a tacrolimus-based immunosuppression DESCRIPTION: A prospective, randomized safety and efficacy study of long-acting insulin (Insulatard®) as therapy against… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Insulatard (long-acting insulin) and Conventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2009to May 2011
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- renal transplantation (deceased or living donor)
- eligibility for the standard immunosuppression of our center, consisting of tacrolimus, mycophenolate mofetil or mycophenolic acid, dexamethasone/prednisone triple therapy
- informed consent of the patient
Who cannot join
- patients with type 1 or type 2 diabetes
- allergy against long-acting insulin
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Internal Medicine III
Vienna, 1090
About this study
Official title: Treat-to-target Trial of Basal Insulin in Post-transplant Hyperglycemia (TIP): Efficacy and Safety of a Novel Protocol in Renal Transplant Recipients Receiving a Tacrolimus-based Immunosuppression
Treat-to-target trial of basal Insulin in Post-transplant hyperglycemia (TIP): efficacy and safety of a novel protocol in renal transplant recipients receiving a tacrolimus-based immunosuppression
DESCRIPTION:
Read more
A prospective, randomized safety and efficacy study of long-acting insulin (Insulatard®) as therapy against post-transplant hyperglycemia in renal transplant recipients
OBJECTIVES:
Primary Objective:
To demonstrate superiority of long-acting insulin (Insulatard®) against post-transplant hyperglycemia, in comparison to conventional treatment, and as evaluated by HbA1c
Secondary Objectives:
- To assess the average post-transplant glucose levels in renal transplant patients under conventional blood-glucose lowering therapy during a period of at least 14 days after transplantation by measuring the capillary blood glucose levels four times daily in both groups of patients (fasting, before lunch, before supper, after supper)
- To detect the number of post-transplant patients who - without any history of pre-transplant diabetes - develop at least one episode of post-transplant hyperglycemia (> 140 mg/dl before supper)
- To detect the average number of hyperglycemic episodes in post-transplant patients with at least one episode of post-transplant hyperglycemia and without any history of diabetes
- To assess the amount of (long-acting) insulin (in IU) needed in order to obtain a target capillary blood glucose level in the range of 110 mg/dl to 120 mg/dl before supper in post-transplant patients with incidence of hyperglycemia
- To assess the safety of long-acting insulin in controlling post-transplant hyperglycemia (especially with regards to episodes of hypoglycemia (glucose-level < 60 mg/dl)
- To assess the prevalence of post-transplant diabetes, as diagnosed by an abnormal oral glucose tolerance on days 90, 180 and 360 after transplantation, in the group of patients which has been treated with long-acting insulin, in comparison to patients who received conventional treatment
- To assess the morbidity (hospitalization, infections, subsequent episodes of surgery, requirement of non-immunosuppressive, non- blood glucose lowering medication) in the group of patients with long-acting insulin for hyperglycemia, in comparison to patients randomized into the group receiving conventional treatment
- To assess the renal outcome (creatinine levels, rejections) in the group of patients which is foreseen to be treated with long-acting insulin for hyperglycemia, in comparison to patients randomized into the group receiving conventional treatment
Read the detailed description
DESIGN / PHASE:
Prospective, single-center, randomized, parallel group, controlled, phase II study.
STUDY PLANNED DURATION:
First patient First visit 1Q 2009 Last patient First visit 4Q 2009 Last patient Last visit 4Q 2010
CENTERS:
Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria, Department of Surgery, Division of Transplantation, Medical University of Vienna, Austria
PATIENTS / GROUPS:
50 patients in 2 groups 25 patients per group Randomization ratio 1:1, no stratification
Capillary blood glucose will be measured four times daily: before breakfast (7:30 am), before lunch (12 pm), before supper (5:30 pm) and after supper (9 pm) in both groups by the nursing personnel/academic investigators. In group No.1 (study arm A), patients will be treated with long-acting insulin (Insulatard) as soon as the glucose-level before supper surpasses 140 mg/dl. The normoglycemic goal in this group will be from 110 to 120 mg/dl.
In group No.2 (study arm B), the glucose levels will be recorded, but the treatment will be left up to the ward, which is relying on conventional morning glucose measurements. For safety, any glucose levels >180 mg/dl will be reported, and all measures taken by the ward will be recorded. As there are no available guidelines however concerning the so called "conventional" blood glucose-lowering therapy in renal transplant patients, especially during this very early post-transplant phase, the following suggestions will be brought to the attention of the ward in order to standardize the treatment of the patients in study arm B: 1. Treatment in this group should be initiated if the fasting glucose level surpasses the renal glucose threshold, i.e. 180 mg/dl. 2. As the proposed life-style modifications for the treatment of NODAT1 are not feasible during this very early post-transplant phase, the basis of the conventional therapy will be proposed to be sulfonyl urea drugs (i.e. Gliclazide - Diamicron®, 30 mg, not more than three times daily). 3. Short-acting insulin will be strongly recommended to be used for corrections of capillary blood glucose levels above 250 mg/dl.
EFFICACY ENDPOINTS:
Primary:
- HbA1c levels
Secondary:
- capillary blood glucose profile in patients treated with long-acting insulin and in the control group, as evaluated by the daily measurements
- number of patients and overall number of days with hyperglycemia > 140 mg/dl (in each group)
- number of patients and overall number of days with hyperglycemia > 200 mg/dl (in each group)
- number of patients and overall number of days with hypoglycemia < 60 mg/dl in each group
- number of patients with abnormal glucose tolerance on days 90, 180 and 360 after transplantation
TOLERABILITY / SAFETY ENDPOINTS:
- Number of incidences of symptomatic hypoglycemia, confirmed by capillary blood glucose levels < 60 mg/dl
PHARMACOKINETIC / PHARMACODYNAMIC ENDPOINTS:
Doses of (long-acting) insulin
STATISTICAL METHODOLOGY:
Primary Endpoint:
HbA1c (rel %)
Null and alternative hypotheses:
H0 Treatment of hyperglycemia > 140 mg/dl before supper with long-acting insulin in renal transplant recipients for a period of at least 14 days after transplantation is equal to conventional treatment in reducing the HbA1c (measured on day 90 after transplantation).
H1: Treatment of hyperglycemia > 140 mg/dl before supper with long-acting insulin in renal transplant recipients for a period of at least 14 days after transplantation is superior to conventional treatment in reducing the HbA1c (measured on day 90 after transplantation).
Type-I and -II errors - power:
α=0.05 ß=0.2
Statistical methodology:
One-sided t-test of HbA1c on day 90 after transplantation, one-sided t-test of number of days with hyperglycemia > 140 mg/dl before supper, comparison of capillary blood glucose levels by ANOVA
Sample size calculation:
Based on a two-sided testing and an expected standard deviation of HbA1c of 10%, an α=0.05 and a ß=0.2, a sample size of 25 patients per group was determined.
Main analysis set:
Per-protocol (efficacy) and intention to treat (ITT) for safety
Other endpoints:
descriptive statistics
- Conditions
- Hyperglycemia
- Being tested
- Insulatard (long-acting insulin), Conventional
- Keywords
- TIP, NODAT, hyperglycemia, long-acting insulin, post-transplant hyperglycemia
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulatard (long-acting insulin)Drug
In group No.1 (study arm 1 (=A)), patients will be treated with long-acting insulin (Insulatard) as soon as the glucose-level before supper surpasses 140 mg/dl. The normoglycemic goal in this group will be from 110 to 120 mg/dl.
ConventionalDrug
In group No.2 (study arm 2 (=B)), patients will be treated conventionally according to the decisions taken by the physicians on the ward. The following suggestions will be brought to the attention of the ward in order to standardize the treatment of the patients in study arm B: 1. Treatment in this group should be initiated if the fasting glucose level surpasses the renal glucose threshold, i.e. 180 mg/dl. 2. As the proposed life-style modifications for the treatment of NODAT1 are not feasible during this very early post-transplant phase, the basis of the conventional therapy will be proposed to be sulfonyl urea drugs (i.e. Gliclazide - Diamicron®, 30 mg, not more than twice daily). 3. Short-acting insulin will be strongly recommended to be used for corrections of capillary blood glucose levels above 250 mg/dl.
| Study group | Role | What they receive |
|---|---|---|
| 1 Insulatard (long-acting insulin) | Active comparator | Not described Receives: Drug: Insulatard (long-acting insulin) |
| 2 Conventional treatment | Active comparator | Not described Receives: Drug: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the difference in HbA1c between the two study arms.
Measured: post-transplant day 90
Secondary outcomes (6)
Capillary blood glucose profiles in each group
Measured: post-transplant day 1-21
Number of patients and overall number of days with hyperglycemia >140 mg/dl before supper (in each group)
Measured: post-transplant day 1 - 21
Number of patients and overall number of days with hyperglycemia >200 mg/dl (in each group)
Measured: post-transplant day 1-21
Number of patients and overall number of days with hypoglycemia <60 mg/dl in each group
Measured: post-transplant day 1-21
Number of patients with abnormal glucose tolerance
Measured: post-transplant day 90, 180 and 360
Difference in HbA1c between the two study arms
Measured: post-transplant day 180 and 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcus Saemann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcus Saemann, Medical University of Vienna
- Investigators
- Wilfred Druml, MD, Study chair, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830297
- Sponsor's protocol ID
- EudraCT: 2008-005951-84
- Acronym
- TIP
- Status last verified
- Aug 2012
- First submitted
- 26 Jan 2009
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Davidson JA, Wilkinson A; International Expert Panel on New-Onset Diabetes after Transplantation. New-Onset Diabetes After Transplantation 2003 International Consensus Guidelines: an endocrinologist's view. Diabetes Care. 2004 Mar;27(3):805-12. doi: 10.2337/diacare.27.3.805. No abstract available.
PubMed 14988309Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.
PubMed 32803882
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treat-to-target Trial of Basal Insulin in Post-transplant Hyperglycemia (TIP): Efficacy and Safety of a Novel Protocol in Renal Transplant Recipients Receiving a Tacrolimus-based Immunosuppression
- ClinicalTrials.gov ID
- NCT00830297
- Acronym / sponsor ID
- TIP / EudraCT: 2008-005951-84
- Conditions
- Hyperglycemia
- Keywords
- TIP, NODAT, hyperglycemia, long-acting insulin, post-transplant hyperglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Marcus SaemannUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Jan 2009 (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.
Treat-to-target trial of basal Insulin in Post-transplant hyperglycemia (TIP): efficacy and safety of a novel protocol in renal transplant recipients receiving a tacrolimus-based immunosuppression
DESCRIPTION:
A prospective, randomized safety and efficacy study of long-acting insulin (Insulatard®) as therapy against post-transplant hyperglycemia in renal transplant recipients
OBJECTIVES:
Primary Objective:
To demonstrate superiority of long-acting insulin (Insulatard®) against post-transplant hyperglycemia, in comparison to conventional treatment, and as evaluated by HbA1c
Secondary Objectives:
- To assess the average post-transplant glucose levels in renal transplant patients under conventional blood-glucose lowering therapy during a period of at least 14 days after transplantation by measuring the capillary blood glucose levels four times daily in both groups of patients (fasting, before lunch, before supper, after supper)
- To detect the number of post-transplant patients who - without any history of pre-transplant diabetes - develop at least one episode of post-transplant hyperglycemia (> 140 mg/dl before supper)
- To detect the average number of hyperglycemic episodes in post-transplant patients with at least one episode of post-transplant hyperglycemia and without any history of diabetes
- To assess the amount of (long-acting) insulin (in IU) needed in order to obtain a target capillary blood glucose level in the range of 110 mg/dl to 120 mg/dl before supper in post-transplant patients with incidence of hyperglycemia
- To assess the safety of long-acting insulin in controlling post-transplant hyperglycemia (especially with regards to episodes of hypoglycemia (glucose-level < 60 mg/dl)
- To assess the prevalence of post-transplant diabetes, as diagnosed by an abnormal oral glucose tolerance on days 90, 180 and 360 after transplantation, in the group of patients which has been treated with long-acting insulin, in comparison to patients who received conventional treatment
- To assess the morbidity (hospitalization, infections, subsequent episodes of surgery, requirement of non-immunosuppressive, non- blood glucose lowering medication) in the group of patients with long-acting insulin for hyperglycemia, in comparison to patients randomized into the group receiving conventional treatment
- To assess the renal outcome (creatinine levels, rejections) in the group of patients which is foreseen to be treated with long-acting insulin for hyperglycemia, in comparison to patients randomized into the group receiving conventional treatment
Detailed description
DESIGN / PHASE:
Prospective, single-center, randomized, parallel group, controlled, phase II study.
STUDY PLANNED DURATION:
First patient First visit 1Q 2009 Last patient First visit 4Q 2009 Last patient Last visit 4Q 2010
CENTERS:
Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria, Department of Surgery, Division of Transplantation, Medical University of Vienna, Austria
PATIENTS / GROUPS:
50 patients in 2 groups 25 patients per group Randomization ratio 1:1, no stratification
Capillary blood glucose will be measured four times daily: before breakfast (7:30 am), before lunch (12 pm), before supper (5:30 pm) and after supper (9 pm) in both groups by the nursing personnel/academic investigators. In group No.1 (study arm A), patients will be treated with long-acting insulin (Insulatard) as soon as the glucose-level before supper surpasses 140 mg/dl. The normoglycemic goal in this group will be from 110 to 120 mg/dl.
In group No.2 (study arm B), the glucose levels will be recorded, but the treatment will be left up to the ward, which is relying on conventional morning glucose measurements. For safety, any glucose levels >180 mg/dl will be reported, and all measures taken by the ward will be recorded. As there are no available guidelines however concerning the so called "conventional" blood glucose-lowering therapy in renal transplant patients, especially during this very early post-transplant phase, the following suggestions will be brought to the attention of the ward in order to standardize the treatment of the patients in study arm B: 1. Treatment in this group should be initiated if the fasting glucose level surpasses the renal glucose threshold, i.e. 180 mg/dl. 2. As the proposed life-style modifications for the treatment of NODAT1 are not feasible during this very early post-transplant phase, the basis of the conventional therapy will be proposed to be sulfonyl urea drugs (i.e. Gliclazide - Diamicron®, 30 mg, not more than three times daily). 3. Short-acting insulin will be strongly recommended to be used for corrections of capillary blood glucose levels above 250 mg/dl.
EFFICACY ENDPOINTS:
Primary:
- HbA1c levels
Secondary:
- capillary blood glucose profile in patients treated with long-acting insulin and in the control group, as evaluated by the daily measurements
- number of patients and overall number of days with hyperglycemia > 140 mg/dl (in each group)
- number of patients and overall number of days with hyperglycemia > 200 mg/dl (in each group)
- number of patients and overall number of days with hypoglycemia < 60 mg/dl in each group
- number of patients with abnormal glucose tolerance on days 90, 180 and 360 after transplantation
TOLERABILITY / SAFETY ENDPOINTS:
- Number of incidences of symptomatic hypoglycemia, confirmed by capillary blood glucose levels < 60 mg/dl
PHARMACOKINETIC / PHARMACODYNAMIC ENDPOINTS:
Doses of (long-acting) insulin
STATISTICAL METHODOLOGY:
Primary Endpoint:
HbA1c (rel %)
Null and alternative hypotheses:
H0 Treatment of hyperglycemia > 140 mg/dl before supper with long-acting insulin in renal transplant recipients for a period of at least 14 days after transplantation is equal to conventional treatment in reducing the HbA1c (measured on day 90 after transplantation).
H1: Treatment of hyperglycemia > 140 mg/dl before supper with long-acting insulin in renal transplant recipients for a period of at least 14 days after transplantation is superior to conventional treatment in reducing the HbA1c (measured on day 90 after transplantation).
Type-I and -II errors - power:
α=0.05 ß=0.2
Statistical methodology:
One-sided t-test of HbA1c on day 90 after transplantation, one-sided t-test of number of days with hyperglycemia > 140 mg/dl before supper, comparison of capillary blood glucose levels by ANOVA
Sample size calculation:
Based on a two-sided testing and an expected standard deviation of HbA1c of 10%, an α=0.05 and a ß=0.2, a sample size of 25 patients per group was determined.
Main analysis set:
Per-protocol (efficacy) and intention to treat (ITT) for safety
Other endpoints:
descriptive statistics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Insulatard (long-acting insulin) | Active comparator | Drug: Insulatard (long-acting insulin) |
| 2 Conventional treatment | Active comparator | Drug: Conventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- renal transplantation (deceased or living donor)
- eligibility for the standard immunosuppression of our center, consisting of tacrolimus, mycophenolate mofetil or mycophenolic acid, dexamethasone/prednisone triple therapy
- informed consent of the patient
Key exclusion criteria (2 listed)
- patients with type 1 or type 2 diabetes
- allergy against long-acting insulin
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 |
|---|---|---|
| Insulatard (long-acting insulin)In group No.1 (study arm 1 (=A)), patients will be treated with long-acting insulin (Insulatard) as soon as the glucose-level before supper surpasses 140 mg/dl. The normoglycemic goal in this group will be from 110 to 120 mg/dl. | Drug | 1 Insulatard (long-acting insulin) |
| ConventionalIn group No.2 (study arm 2 (=B)), patients will be treated conventionally according to the decisions taken by the physicians on the ward. The following suggestions will be brought to the attention of the ward in order to standardize the treatment of the patients in study arm B: 1. Treatment in this group should be initiated if the fasting glucose level surpasses the renal glucose threshold, i.e. 180 mg/dl. 2. As the proposed life-style modifications for the treatment of NODAT1 are not feasible during this very early post-transplant phase, the basis of the conventional therapy will be proposed to be sulfonyl urea drugs (i.e. Gliclazide - Diamicron®, 30 mg, not more than twice daily). 3. Short-acting insulin will be strongly recommended to be used for corrections of capillary blood glucose levels above 250 mg/dl. | Drug | 2 Conventional treatment |
Primary outcome
The primary endpoint is the difference in HbA1c between the two study arms.
Time frame: post-transplant day 90
6 secondary outcomes
Capillary blood glucose profiles in each group
Time frame: post-transplant day 1-21
Number of patients and overall number of days with hyperglycemia >140 mg/dl before supper (in each group)
Time frame: post-transplant day 1 - 21
Number of patients and overall number of days with hyperglycemia >200 mg/dl (in each group)
Time frame: post-transplant day 1-21
Number of patients and overall number of days with hypoglycemia <60 mg/dl in each group
Time frame: post-transplant day 1-21
Number of patients with abnormal glucose tolerance
Time frame: post-transplant day 90, 180 and 360
Difference in HbA1c between the two study arms
Time frame: post-transplant day 180 and 360
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 3 Sep 2012.
- Background: PubMed 14988309Davidson JA, Wilkinson A; International Expert Panel on New-Onset Diabetes after Transplantation. New-Onset Diabetes After Transplantation 2003 International Consensus Guidelines: an endocrinologist's view. Diabetes Care. 2004 Mar;27(3):805-12. doi: 10.2337/diacare.27.3.805. No abstract available.
- Derived from this study: PubMed 32803882Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.
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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.
Wilfred Druml, MD study chair
Medical University of Vienna
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 Insulatard (long-acting insulin) and Conventional in people with Hyperglycemia, run by Marcus Saemann at 1 site in Austria.
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 3 inclusion and 2 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 3 Sep 2012. 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 Austria. 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?
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?
The primary endpoint is the difference in HbA1c between the two study arms. (time frame: post-transplant day 90). 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 NCT00830297, 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 3 Sep 2012.