Diabetes Mellitus Type 2Phase 3NCT00425490
Effect of Januvia on Beta Cell Function in Patients With Diabetes Mellitus
A Phase 3 study testing sitagliptin in people with Diabetes Mellitus Type 2, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The study is designed to investigate the effect of 18 weeks treatment with Sitagliptin 100 mg/day on the insulin secretion capacity of beta cells. Patients who meet the study enrollment criteria will undergo 2 experiments (see description below); a graded hyperglycemic technique and a meal test, prior to randomization… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- sitagliptin
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2007to Jul 2009
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has T2DM diagnosed within the past 5 years
- Patient is >18 and <65 years of age
- Patient is not pregnant, breast feeding and unlikely to conceive
- Patient understands the study procedures, and agrees to participate in the study by giving written informed consent
- Patient meets one of the following criteria:
- Patient is currently not on an AHA and has a Visit 1 HbA1c ≥6.5% and ≤10%. OR
- Patient is currently on AHA monotherapy or low dose (i.e. ≤50% maximum labeled dose of each agent) oral combination therapy and has a Screening/Visit 1 HbA1c ≥6.5% and ≤9.5%.
- At visit 2, patient has a HbA1c of ≥6.5% and ≤10%
Who cannot join
- Patient has type 1 diabetes mellitus
- Patient required insulin therapy within 12 weeks of Visit 1. Note: patients who received a brief period of insulin treatment (e.g., several days during a hospitalization) and who are no longer requiring insulin treatment may participate
- Patient is currently or within 12 weeks of Visit 1 taking a TZD agent as monotherapy or in combination
- Patient is currently or within 12 weeks of Visit 1 taking Byetta.
- Patient is on corticosteroids
- Patient has a history of malignancy ≤5 years prior to signing informed consent, or >5 years without documentation of remission/cure Exception: Adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Melanoma, leukemia, lymphoma and myeloproliferative disorders of any duration are excluded -Patient is on chemotherapy
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- Patient received another investigational drug in the last 12 weeks.
- Patients with concomitant liver disease and or AST > 3 fold upper limit of normal
- Patients with kidney disease or CR>1.4 mg/dl
- Patients with anemia ( Hb <11 gr in male 10 gr in female)
- Patient with active vascular disease (coronary, peripheral or cerebrovascular)
- Patient has poorly controlled hypertension defined as systolic blood pressure >160 mm Hg or diastolic >95 mm Hg
- Proliferative retinopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Study on the Effect of Sitagliptin on Maximal Beta Cell Stimulation
The study is designed to investigate the effect of 18 weeks treatment with Sitagliptin 100 mg/day on the insulin secretion capacity of beta cells.
Patients who meet the study enrollment criteria will undergo 2 experiments (see description below); a graded hyperglycemic technique and a meal test, prior to randomization and after a 12-wk double-blind study period. The treatment effect will shed light on the magnitude of the beta cell capacity to increase its mass and function.
Read the detailed description
Study design and duration: This will be an Israeli three center study. Study drug: Sitagliptin 100 mg. The study will be a double blind, randomized two arms parallel group study. The duration of the study will be up to 18 weeks (with 8 visits) for each patient. This will include: a screening period of up to 4 weeks (Visit 1 to visit 2), a 2 week single blind, placebo run-in period (visit 2 to visit 4), and a 12 week placebo controlled, double blind treatment period (visit 4 to visit 8).
Patients with T2DM who have not been treated with an AHA, or who are on AHA monotherapy or low dose oral combination therapy (low dose defined as ≤50% of the maximum labeled dose of each agent), may participate if they meet all enrollment criteria. Patients eligible to be randomized will have a HbA1c ³6.5% and £10% .
Patients who meet the study enrollment criteria will undergo 2 experiments (see description below); a graded hyperglycemic technique and a meal test, prior to randomization (Visit 3 and 4). These experiments will be will be completed after a 12-hour overnight fast. The 2 experiments will be repeated at the conclusion of the 12-wk double-blind study period (Visits 7 and 8).
Efficacy measurements: (1) Glycemic control : FPG, HbA1c, β-cell Function Parameters(Φs, Φd, Φb, Φ, Φob, T), Insulin Secretion Rate (determined from C-peptide deconvolution), 1st and 2nd phase insulin secretion, Insulin response after arginine injection, Insulin sensitivity index, glucose, insulin, C-peptide total and incremental area under the curve.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- sitagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sitagliptinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
FPG,
HbA1c,
β-cell Function Parameters(Φs, Φd, Φb, Φ, Φob, T), Insulin Secretion Rate (determined from C-peptide deconvolution), 1st and 2nd phase insulin secretion, Insulin response after arginine injection, Insulin sensitivity index, glucose, insulin,
C-peptide total and incremental area under the curve.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Ohad Cohen, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425490
- Sponsor's protocol ID
- SHEBA-06-4373-OC-CTIL
- Status last verified
- Sep 2009
- First submitted
- 22 Jan 2007
- Last updated
- 23 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study on the Effect of Sitagliptin on Maximal Beta Cell Stimulation
- ClinicalTrials.gov ID
- NCT00425490
- Acronym / sponsor ID
- SHEBA-06-4373-OC-CTIL
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 Jan 2007 (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.
The study is designed to investigate the effect of 18 weeks treatment with Sitagliptin 100 mg/day on the insulin secretion capacity of beta cells.
Patients who meet the study enrollment criteria will undergo 2 experiments (see description below); a graded hyperglycemic technique and a meal test, prior to randomization and after a 12-wk double-blind study period. The treatment effect will shed light on the magnitude of the beta cell capacity to increase its mass and function.
Detailed description
Study design and duration: This will be an Israeli three center study. Study drug: Sitagliptin 100 mg. The study will be a double blind, randomized two arms parallel group study. The duration of the study will be up to 18 weeks (with 8 visits) for each patient. This will include: a screening period of up to 4 weeks (Visit 1 to visit 2), a 2 week single blind, placebo run-in period (visit 2 to visit 4), and a 12 week placebo controlled, double blind treatment period (visit 4 to visit 8).
Patients with T2DM who have not been treated with an AHA, or who are on AHA monotherapy or low dose oral combination therapy (low dose defined as ≤50% of the maximum labeled dose of each agent), may participate if they meet all enrollment criteria. Patients eligible to be randomized will have a HbA1c ³6.5% and £10% .
Patients who meet the study enrollment criteria will undergo 2 experiments (see description below); a graded hyperglycemic technique and a meal test, prior to randomization (Visit 3 and 4). These experiments will be will be completed after a 12-hour overnight fast. The 2 experiments will be repeated at the conclusion of the 12-wk double-blind study period (Visits 7 and 8).
Efficacy measurements: (1) Glycemic control : FPG, HbA1c, β-cell Function Parameters(Φs, Φd, Φb, Φ, Φob, T), Insulin Secretion Rate (determined from C-peptide deconvolution), 1st and 2nd phase insulin secretion, Insulin response after arginine injection, Insulin sensitivity index, glucose, insulin, C-peptide total and incremental area under the curve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient has T2DM diagnosed within the past 5 years
- Patient is >18 and <65 years of age
- Patient is not pregnant, breast feeding and unlikely to conceive
- Patient understands the study procedures, and agrees to participate in the study by giving written informed consent
- Patient meets one of the following criteria:
Key exclusion criteria (13 listed)
- Patient has type 1 diabetes mellitus
- Patient required insulin therapy within 12 weeks of Visit 1. Note: patients who received a brief period of insulin treatment (e.g., several days during a hospitalization) and who are no longer requiring insulin treatment may participate
- Patient is currently or within 12 weeks of Visit 1 taking a TZD agent as monotherapy or in combination
- Patient is currently or within 12 weeks of Visit 1 taking Byetta.
- Patient is on corticosteroids
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 |
|---|---|---|
| sitagliptin | Drug | – |
Primary outcome
FPG,
HbA1c,
β-cell Function Parameters(Φs, Φd, Φb, Φ, Φob, T), Insulin Secretion Rate (determined from C-peptide deconvolution), 1st and 2nd phase insulin secretion, Insulin response after arginine injection, Insulin sensitivity index, glucose, insulin,
C-peptide total and incremental area under the curve.
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 23 Sep 2009.
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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.
Ohad Cohen, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sitagliptin in people with Diabetes Mellitus Type 2, run by Sheba Medical Center at 1 site in Israel.
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 8 inclusion and 13 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 23 Sep 2009. 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 Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
FPG,. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2009.