Diabetes MellitusPhase 4NCT02182895
Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
A Phase 4 study testing Saxagliptin in people with Diabetes Mellitus, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to test the safety and efficacy of a drug called saxagliptin (Onglyza) for treatment of type 2 diabetes in non-critically ill hospitalized patients who have an HbA1c of 7.5 or lower, on 1 or no non-insulin agent at home, or an HbA1c ≤7.0% on ≤ 2 non-insulin agents at home. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Saxagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Feb 2017
- Phase
- Phase 4
- 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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with T2DM and HbA1C ≤7.5% on ≤1 non-insulin hypoglycemic agent or HbA1C ≤7.0% on ≤2 non-insulin hypoglycemic agents admitted to the hospital for a non-critical illness.
- Written informed consent.
Who cannot join
- Admitted to or expected to require admission to ICU
- Patients with a history of diabetic ketoacidosis or hyperosmolar state
- HbA1c >7.5% at the time of admission or within 3 months before admission
- Insulin requiring before admission
- Unable to take oral food or medications
- Systemic steroid use
Show all 12Show fewer
- Pregnancy or breastfeeding
- Women of Child-Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug.
- History of pancreatitis or active gallbladder disease
- End stage renal disease on dialysis
- Hypersensitivity to saxagliptin or another contraindication to DPP4 inhibitors
- Subject unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The purpose of this research study is to test the safety and efficacy of a drug called saxagliptin (Onglyza) for treatment of type 2 diabetes in non-critically ill hospitalized patients who have an HbA1c of 7.5 or lower, on 1 or no non-insulin agent at home, or an HbA1c ≤7.0% on ≤ 2 non-insulin agents at home.
Read the detailed description
The current professional organization guidelines recommend insulin as the preferred treatment for hospitalized patients. It is recommended that most critically ill patients should receive insulin infusion therapy and non-critically ill patients should receive basal bolus insulin therapy in the hospital.
The study will test the hypothesis that treatment with saxagliptin is non-inferior to treatment with basal bolus insulin in this group of patients during their hospital stay. The study will evaluate the effect of saxagliptin, a DPP4 inhibitor, on glycemic control in non-critically ill hospitalized patients with type 2 diabetes mellitus (T2DM)
The primary outcome will be mean daily blood glucose levels during hospital days 2 to 5. The study is designed to detect a non-inferiority margin of 20% in the saxagliptin group as compared to the control group
- Conditions
- Diabetes Mellitus
- Being tested
- Saxagliptin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaxagliptinDrug
Also called Onglyza, DPP4 inhibitor
2.5-5 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Saxagliptin group | Experimental | DPP4 inhibitor therapy group will receive saxagliptin 2.5 to 5 mg daily in addition to correctional sliding scale insulin therapy before each meal and bedtime. Receives: Drug: Saxagliptin |
| Standard therapy group | No intervention | Standard therapy group will receive basal-bolus insulin starting at a dose of 0.5 units/kg/day; given half as insulin glargine and half as insulin aspart. In addition, the standard therapy group will receive the correctional sliding scale insulin therapy before each meal and bedtime. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Daily Blood Glucose Levels During Hospital
mean of average daily blood blood glucose for each patient day
Measured: Hospital days 2-5
Secondary outcomes (7)
Percentage of Blood Glucose Readings in 70-140 mg/dL Range
Percentage of BG readings in the desired range of 70-140 mg/dl out of all avaialble BG readings.
Measured: Days 2 to 5
Dose of Insulin
Average daily amount of insulin used
Measured: Days 2 to 5
Incidence of Hypoglycemia (BG <70 mg/dL)
Number of BG readings <70 mg/dL in each group
Measured: Days 2 to 5
Incidence of Hyperglycemia (Blood Glucose >200 mg/dL)
Proportion of BG readings in the severe hyperglycemic range.
Measured: Days 2 to 5
Variability in Glucose Levels
Mean amplitude of glycemic excursions
Measured: Days 2 to 5
Length of Hospital Stay
Number of days in hospital
Measured: Admission to discharge, an expected average of 5 days
Patient Satisfaction
Diabetes Treatment Satisfaction Questionnaire - InPatient (DTSQ-IP). This questionnaire had 14 items that were scored on a scale of 0 to 6. Total score for each subjects could range from 0-84. Higher score means better satisfaction.
Measured: At the time of discharge or Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2017
- Study completionFeb 2017
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajesh K. Garg, Brigham and Women's Hospital
- Investigators
- Rajesh K Garg, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182895
- Sponsor's protocol ID
- 2014P001095
- Status last verified
- May 2017
- First submitted
- 30 Jun 2014
- Last updated
- 23 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share data.
Publications
Garg R, Schuman B, Hurwitz S, Metzger C, Bhandari S. Safety and efficacy of saxagliptin for glycemic control in non-critically ill hospitalized patients. BMJ Open Diabetes Res Care. 2017 Mar 29;5(1):e000394. doi: 10.1136/bmjdrc-2017-000394. eCollection 2017.
PubMed 28405346
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
- ClinicalTrials.gov ID
- NCT02182895
- Acronym / sponsor ID
- 2014P001095
- Conditions
- Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Posted 1 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test the safety and efficacy of a drug called saxagliptin (Onglyza) for treatment of type 2 diabetes in non-critically ill hospitalized patients who have an HbA1c of 7.5 or lower, on 1 or no non-insulin agent at home, or an HbA1c ≤7.0% on ≤ 2 non-insulin agents at home.
Detailed description
The current professional organization guidelines recommend insulin as the preferred treatment for hospitalized patients. It is recommended that most critically ill patients should receive insulin infusion therapy and non-critically ill patients should receive basal bolus insulin therapy in the hospital.
The study will test the hypothesis that treatment with saxagliptin is non-inferior to treatment with basal bolus insulin in this group of patients during their hospital stay. The study will evaluate the effect of saxagliptin, a DPP4 inhibitor, on glycemic control in non-critically ill hospitalized patients with type 2 diabetes mellitus (T2DM)
The primary outcome will be mean daily blood glucose levels during hospital days 2 to 5. The study is designed to detect a non-inferiority margin of 20% in the saxagliptin group as compared to the control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saxagliptin group | Experimental | Drug: SaxagliptinDPP4 inhibitor therapy group will receive saxagliptin 2.5 to 5 mg daily in addition to correctional sliding scale insulin therapy before each meal and bedtime. |
| Standard therapy group | No intervention | –Standard therapy group will receive basal-bolus insulin starting at a dose of 0.5 units/kg/day; given half as insulin glargine and half as insulin aspart. In addition, the standard therapy group will receive the correctional sliding scale insulin therapy before each meal and bedtime. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with T2DM and HbA1C ≤7.5% on ≤1 non-insulin hypoglycemic agent or HbA1C ≤7.0% on ≤2 non-insulin hypoglycemic agents admitted to the hospital for a non-critical illness.
- Written informed consent.
Key exclusion criteria (12 listed)
- Admitted to or expected to require admission to ICU
- Patients with a history of diabetic ketoacidosis or hyperosmolar state
- HbA1c >7.5% at the time of admission or within 3 months before admission
- Insulin requiring before admission
- Unable to take oral food or medications
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 |
|---|---|---|
| SaxagliptinAlso: Onglyza, DPP4 inhibitor2.5-5 mg daily | Drug | Saxagliptin group |
Primary outcome
Mean Daily Blood Glucose Levels During Hospital
Time frame: Hospital days 2-5
mean of average daily blood blood glucose for each patient day
7 secondary outcomes
Percentage of Blood Glucose Readings in 70-140 mg/dL Range
Time frame: Days 2 to 5
Dose of Insulin
Time frame: Days 2 to 5
Incidence of Hypoglycemia (BG <70 mg/dL)
Time frame: Days 2 to 5
Incidence of Hyperglycemia (Blood Glucose >200 mg/dL)
Time frame: Days 2 to 5
Variability in Glucose Levels
Time frame: Days 2 to 5
Length of Hospital Stay
Time frame: Admission to discharge, an expected average of 5 days
Patient Satisfaction
Time frame: At the time of discharge or Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28405346Garg R, Schuman B, Hurwitz S, Metzger C, Bhandari S. Safety and efficacy of saxagliptin for glycemic control in non-critically ill hospitalized patients. BMJ Open Diabetes Res Care. 2017 Mar 29;5(1):e000394. doi: 10.1136/bmjdrc-2017-000394. eCollection 2017.
- Individual participant dataSharing planned: No. No plan to share data.
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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.
Rajesh K Garg, MD principal investigator
Brigham and Women's Hospital
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 Saxagliptin in people with Diabetes Mellitus, run by Brigham and Women's Hospital at 1 site in United States.
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 2 inclusion and 12 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 Jun 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 1 Jun 2017). 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?
Mean Daily Blood Glucose Levels During Hospital (time frame: Hospital days 2-5). 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 NCT02182895, 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 23 Jun 2017.