Impaired Glucose TolerancePhase 2GCPDNCT01346254
Glucose Control in Pre-Diabetic Renal Transplant Patients
A Phase 2 study testing Vildagliptin, Pioglitazone and Life-Style Modification in people with Impaired Glucose Tolerance and Kidney Transplantation, run by Marcus Saemann at 1 site in Austria.
Trial summary
Development of New-Onset Diabetes after Transplantation (NODAT) is common and serious complication after kidney transplantation. Patients who develop NODAT are at increased risk for loss of the transplanted organ and for diseases of the cardiovascular system. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Impaired Glucose Tolerance, Kidney Transplantation
- What is being tested?
- Vildagliptin, Pioglitazone and Life-Style Modification
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2009to Nov 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 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Time since renal transplantation > 6 months
- Stable graft function
- Routine OGTT has been performed, and pre-diabetes has been diagnosed by pathological OGTT (2h, 75 g glucose, glucose level between 140 and 200 mg/dl)
- Informed consent of the patient
Who cannot join
- Patients with type 1 or type 2 diabetes
- Patients with NODAT (2h glucose level at OGTT >200 mg/dl)
- allergy against vildagliptin or pioglitazone
- pregnancy
- GFR<15ml/min/1.73 with need for dialysis
- hepatic impairment
Trial locations and contacts
1 site in 1 country.
Austria1 site
Allgemeines Krankenhaus der Stadt Wien, Universitätskliniken
Vienna, 1090
About this study
Official title: Glucose Control in Pre-Diabetic Renal Transplant Patients: Efficacy and Safety of Vildagliptin and Pioglitazone
Development of New-Onset Diabetes after Transplantation (NODAT) is common and serious complication after kidney transplantation. Patients who develop NODAT are at increased risk for loss of the transplanted organ and for diseases of the cardiovascular system.
It is believed that in many patients the development of overt NODAT is preceded by a phase of impaired glucose tolerance that is called pre-diabetes.
Read more
This study aims at improving glucose metabolism in patients after kidney transplantation who are in a pre-diabetic metabolic state. Patients who exhibit impaired glucose tolerance (IGT) after kidney transplantation are randomized to either receive vildagliptin (Galvus), pioglitazone(Actos) or placebo for three months.
The investigators hypothesize that treatment with vildagliptin or pioglitazone leads to improved glycemic control compared to placebo.
- Conditions
- Impaired Glucose Tolerance, Kidney Transplantation
- Being tested
- Vildagliptin, Pioglitazone, Life-Style Modification
- Keywords
- after
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VildagliptinDrug
Also called Galvus
50mg tablets once daily 20 min before breakfast for 3 months
PioglitazoneDrug
Also called Actos
30mg tablets once daily 20 min before breakfast for 3 months
Life-Style ModificationBehavioural
All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Experimental | 16 patients randomized into this arm will receive vildagliptin (Galvus) 50mg orally once daily Receives: Drug: Vildagliptin; Behavioral: Life-Style Modification |
| Pioglitazone | Experimental | 16 patients randomized into this arm will receive pioglitazone (Actos) 30mg orally once daily Receives: Drug: Pioglitazone; Behavioral: Life-Style Modification |
| Placebo | Placebo comparator | 16 patients randomized into this arm will receive placebo medication orally once daily Receives: Behavioral: Life-Style Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral glucose tolerance test (OGTT)
Glucose tolerance and insulin resistance three months after study start will be measured by means of a frequent sampling OGTT (75g glucose, determination of glucose, insulin and C-peptide) over 120 mins.
Measured: three months
Secondary outcomes (4)
glycated hemoglobin
HbA1c will be measured after three months and compared between the study arms
Measured: 3 months
Renal function
Renal function will be assessed by measuring serum creatinin and glomerular filtration rate (GFR)at the beginning of the study and after three months of treatment
Measured: 3 months
Liver function
Liver enzymes (ALAT, ASAT, Gamm-GT) will be measured at the start of the study and after three months treatment
Measured: 3 months
Lipid profiles
Lipid profiles will be analyzed at the beginning and end of the study including Cholesterol, HDL, LDL and triglycerides.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startDec 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impaired Glucose ToleranceStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 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
- Marcus Säemann, MD, Principal investigator, Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346254
- Sponsor's protocol ID
- GCPD
- Acronym
- GCPD
- Status last verified
- Dec 2011
- First submitted
- 29 Apr 2011
- Last updated
- 5 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Lo 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 5 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Control in Pre-Diabetic Renal Transplant Patients: Efficacy and Safety of Vildagliptin and Pioglitazone
- ClinicalTrials.gov ID
- NCT01346254
- Acronym / sponsor ID
- GCPD / GCPD
- Conditions
- Impaired Glucose Tolerance, Kidney Transplantation
- Keywords
- after
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Marcus SaemannUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 2 May 2011 (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.
Development of New-Onset Diabetes after Transplantation (NODAT) is common and serious complication after kidney transplantation. Patients who develop NODAT are at increased risk for loss of the transplanted organ and for diseases of the cardiovascular system.
It is believed that in many patients the development of overt NODAT is preceded by a phase of impaired glucose tolerance that is called pre-diabetes.
This study aims at improving glucose metabolism in patients after kidney transplantation who are in a pre-diabetic metabolic state. Patients who exhibit impaired glucose tolerance (IGT) after kidney transplantation are randomized to either receive vildagliptin (Galvus), pioglitazone(Actos) or placebo for three months.
The investigators hypothesize that treatment with vildagliptin or pioglitazone leads to improved glycemic control compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin | Experimental | Drug: Vildagliptin, Behavioral: Life-Style Modification16 patients randomized into this arm will receive vildagliptin (Galvus) 50mg orally once daily |
| Pioglitazone | Experimental | Drug: Pioglitazone, Behavioral: Life-Style Modification16 patients randomized into this arm will receive pioglitazone (Actos) 30mg orally once daily |
| Placebo | Placebo comparator | Behavioral: Life-Style Modification16 patients randomized into this arm will receive placebo medication orally once daily |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Time since renal transplantation > 6 months
- Stable graft function
- Routine OGTT has been performed, and pre-diabetes has been diagnosed by pathological OGTT (2h, 75 g glucose, glucose level between 140 and 200 mg/dl)
- Informed consent of the patient
Key exclusion criteria (6 listed)
- Patients with type 1 or type 2 diabetes
- Patients with NODAT (2h glucose level at OGTT >200 mg/dl)
- allergy against vildagliptin or pioglitazone
- pregnancy
- GFR<15ml/min/1.73 with need for dialysis
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 |
|---|---|---|
| VildagliptinAlso: Galvus50mg tablets once daily 20 min before breakfast for 3 months | Drug | Vildagliptin |
| PioglitazoneAlso: Actos30mg tablets once daily 20 min before breakfast for 3 months | Drug | Pioglitazone |
| Life-Style ModificationAll study participants were counselled regarding life-style modification including regular exercise, weight loss and diet. | Behavioural | Pioglitazone, Placebo, Vildagliptin |
Primary outcome
Oral glucose tolerance test (OGTT)
Time frame: three months
Glucose tolerance and insulin resistance three months after study start will be measured by means of a frequent sampling OGTT (75g glucose, determination of glucose, insulin and C-peptide) over 120 mins.
4 secondary outcomes
glycated hemoglobin
Time frame: 3 months
Renal function
Time frame: 3 months
Liver function
Time frame: 3 months
Lipid profiles
Time frame: 3 months
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 5 Dec 2011.
- 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.
Marcus Säemann, MD principal investigator
Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
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 Vildagliptin, Pioglitazone and Life-Style Modification in people with Impaired Glucose Tolerance and Kidney Transplantation, 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 4 inclusion and 6 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 5 Dec 2011. 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. 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 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?
Oral glucose tolerance test (OGTT) (time frame: three months). 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 NCT01346254, 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 5 Dec 2011.