Type 2 DiabetesPhase 4DapaSaxaBBITNCT02965443
Dapagliflozin + Saxagliptin in a Basal-bolus Insulin Treatment
A Phase 4 study testing Dapagliflozin 10 mg + Saxagliptin 5 mg in people with Type 2 Diabetes, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
To perform a study that investigates the effectiveness of adding the SGLT2 inhibitor dapagliflozin + the dipeptidyl peptidase 4 (DPP-4) inhibitor saxagliptin vs placebo to revert from a BBIT regimen to a BOT regimen in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dapagliflozin 10 mg + Saxagliptin 5 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteGermany
- Study dates
- 2 Feb 2018to 3 Feb 2020
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Age 18 - 75 years
- Anti-GAD antibodies negative (Glutamic Acid Decarboxylase)
- C-peptide levels ≥ 1.5 ng/mL
- Fasting blood glucose > 126 mg/dl
- HbA1c 8.0 - 10.5 %
- BMI 25.0 - 45.0 kg/m2
- Previous therapy with BBIT (basal insulin and at least once daily bolus insulin)
Who cannot join
- Use of any oral antidiabetic treatment except for metformin (i.e., sulphonylureas, DPP-IV inhibitors, thiazolidinediones, SGLT-2 inhibitors (Sodium dependent glucose transporter) or GLP-1 analogues (glucagone like peptide) within the last three months prior to Screening
- Repeated episodes of severe hypoglycaemia within the last six months prior to Screening
- History of diabetic ketoacidosis, precoma diabetica, or diabetic coma
- Treatment with any other investigational drug within the last three months before Screening
- Acute infections within the last four weeks prior to Screening
- Recurrent urogenital infections
Show all 27Show fewer
- History of pancreatitis
- Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- History of severe or multiple allergies
- Concomitant participation in other clinical trials
- Type 1 diabetes
- Cardiovascular disease Clinically relevant ventricular tachycardia or ventricular fibrillation, 3rd degree AV block or Torsades de Pointes or treatment with antiarrhythmic drugs. Percutaneous coronary intervention within the past 6 months. Any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery; unstable angina; or stroke.
- Uncontrolled unstable angina pectoris or history of pericarditis, myocarditis, endocarditis. Congestive heart failure NYHA (New York Heart Association) class III or IV. Increased risk of thromboembolism, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator.
- Malignancy including leukemia and lymphoma within the last 5y.
- Liver disease such as cirrhosis or chronic active hepatitis.
- Significant renal dysfunction (see also exclusion criteria laboratory abnormalities).
- State after kidney transplantation
- Endocrine disease:
- Acromegaly or treatment with growth hormone or similar drugs. Chronic oral or parenteral corticosteroid treatment (>7 consecutive days of treatment) within 8 weeks; thyroid hormone replacement is allowed if the dosage has been stable for at least 3 months and the TSH is within normal limits
- •Any of the following significant laboratory abnormalities: eGFR (as calculated by the MDRD equation) < 60 ml/min at Screening Fasting triglycerides >700 mg/dl (>7.9 mmol/l)
- Systolic blood pressure outside the range of 100-160 mmHg or diastolic blood pressure above 95 mmHg at Screening
- History of active substance abuse (including alcohol > 40g/day) within the past 2 years.
- Pregnancy or childbearing potential without adequate contraception
- Present therapy with systemic steroids
- Presence of psychiatric disorder or intake of anti-depressive or anti-psychotic agents with the exception of benzodiazepines and SSRIs/SNRI´s (selective serotonin reuptake inhibitor)
- Potentially unreliable subjects, and those judged by the investigator to be unsuitable for the study.
- Contraindications for Magnetic resonance (MR) scanning such as persons with cardiac pacemaker and implants out of metal or claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Dapagliflozin + Saxagliptin to Revert From a Basal-bolus Insulin Treatment (BBIT) Regimen to a Basal Supported Oral Therapy (BOT) in Patients With Type 2 Diabetes
To perform a study that investigates the effectiveness of adding the SGLT2 inhibitor dapagliflozin + the dipeptidyl peptidase 4 (DPP-4) inhibitor saxagliptin vs placebo to revert from a BBIT regimen to a BOT regimen in patients with type 2 diabetes.
Read the detailed description
This will be a phase IV study investigating the efficacy and safety of adding the SGLT2 inhibitor dapagliflozin together wih the DPP-4 inhibitor saxagliptin to an intensified insulin treatment regimen. Because BOT is superior to BBIT in respect to the development of bodyweight, hypoglycaemia and patient satisfaction in type 2 diabetes, we hypothesize that the combined addition of the SGLT2 inhibitor dapagliflozin with the DPP-4 inhibitor saxagliptin is effective and safe to revert from a BBIT to a BOT treatment regimen.
- Conditions
- Type 2 Diabetes
- Being tested
- Dapagliflozin 10 mg + Saxagliptin 5 mg, Placebo 1 10 mg + Placebo 2 5 mg
- 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.
Dapagliflozin 10 mg + Saxagliptin 5 mgDrug
Also called Forxiga + Onglyza
24 weeks intervention with Dapagliflozin 10 mg + Saxagliptin 5 mg
Placebo 1 10 mg + Placebo 2 5 mgDrug
Also called Placebo 1 + Placebo 2
24 weeks intervention with Placebo 1 10 mg + Placebo 2 5 mg
| Study group | Role | What they receive |
|---|---|---|
| Verum | Active comparator | Dapagliflozin 10 mg + Saxagliptin 5 mg, each once daily, for 24 weeks Receives: Drug: Dapagliflozin 10 mg + Saxagliptin 5 mg |
| Placebo | Placebo comparator | Placebo 1 10 mg + Placebo 2 5 mg, each once daily, for 24 weeks Receives: Drug: Placebo 1 10 mg + Placebo 2 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen
Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen with treatment of dapagliflozin/saxagliptin or placebo
Measured: 24 weeks
Secondary outcomes (14)
changes in HbA1c between groups
treatment of dapagliflozin/saxagliptin or placebo
Measured: 24 weeks
changes in hypoglycaemic events between groups
treatment of dapagliflozin/saxagliptin or placebo
Measured: 24 weeks
changes in fasting blood glucose between groups
treatment of dapagliflozin/saxagliptin or placebo
Measured: 24 weeks
changes in daily insulin dose between groups
treatment of dapagliflozin/saxagliptin or placebo
Measured: 24 weeks
changes in bodyweight between groups
treatment of dapagliflozin/saxagliptin or placebo
Measured: 24 weeks
changes in body fat content between groups
treatment of dapagliflozin/saxagliptin or placebo
Measured: 24 weeks
changes in body fat distribution between groups
treatment of dapagliflozin/saxagliptin or placebo
Measured: 24 weeks
changes in liver fat content between groups
treatment of dapagliflozin/saxagliptin or placebo
Measured: 24 weeks
changes in intra-nasal insulin-induced brain fMR (functional magnetic resonance) imaging results between groups
treatment of dapagliflozin/saxagliptin or placebo
Measured: 24 weeks
changes in blood pressure between groups
treatment of dapagliflozin/saxagliptin or placebo
Measured: 24 weeks
changes in the blood lipid profile between groups
treatment of dapagliflozin/saxagliptin or placebo
Measured: 24 weeks
changes in microalbuminuria between groups
treatment of dapagliflozin/saxagliptin or placebo
Measured: 24 weeks
changes in well being and disease perception between groups
treatment of dapagliflozin/saxagliptin or placebo
Measured: 24 weeks
changes in fear of hypoglycemia between groups
treatment of dapagliflozin/saxagliptin or placebo
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study start2 Feb 2018
- Primary completion3 Feb 2020
- Study completion3 Feb 2020
Why it stopped: Low patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965443
- Sponsor's protocol ID
- UTUB - 2015-005740-34
- Acronym
- DapaSaxaBBIT
- Status last verified
- May 2018
- First submitted
- 28 Oct 2016
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dapagliflozin + Saxagliptin to Revert From a Basal-bolus Insulin Treatment (BBIT) Regimen to a Basal Supported Oral Therapy (BOT) in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02965443
- Acronym / sponsor ID
- DapaSaxaBBIT / UTUB - 2015-005740-34
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low patient recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 3 Feb 2020 (actual)
- First posted
- 16 Nov 2016 (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.
To perform a study that investigates the effectiveness of adding the SGLT2 inhibitor dapagliflozin + the dipeptidyl peptidase 4 (DPP-4) inhibitor saxagliptin vs placebo to revert from a BBIT regimen to a BOT regimen in patients with type 2 diabetes.
Detailed description
This will be a phase IV study investigating the efficacy and safety of adding the SGLT2 inhibitor dapagliflozin together wih the DPP-4 inhibitor saxagliptin to an intensified insulin treatment regimen. Because BOT is superior to BBIT in respect to the development of bodyweight, hypoglycaemia and patient satisfaction in type 2 diabetes, we hypothesize that the combined addition of the SGLT2 inhibitor dapagliflozin with the DPP-4 inhibitor saxagliptin is effective and safe to revert from a BBIT to a BOT treatment regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Active comparator | Drug: Dapagliflozin 10 mg + Saxagliptin 5 mgDapagliflozin 10 mg + Saxagliptin 5 mg, each once daily, for 24 weeks |
| Placebo | Placebo comparator | Drug: Placebo 1 10 mg + Placebo 2 5 mgPlacebo 1 10 mg + Placebo 2 5 mg, each once daily, for 24 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetes
- Age 18 - 75 years
- Anti-GAD antibodies negative (Glutamic Acid Decarboxylase)
- C-peptide levels ≥ 1.5 ng/mL
- Fasting blood glucose > 126 mg/dl
Key exclusion criteria (27 listed)
- Use of any oral antidiabetic treatment except for metformin (i.e., sulphonylureas, DPP-IV inhibitors, thiazolidinediones, SGLT-2 inhibitors (Sodium dependent glucose transporter) or GLP-1 analogues (glucagone like peptide) within the last three months prior to Screening
- Repeated episodes of severe hypoglycaemia within the last six months prior to Screening
- History of diabetic ketoacidosis, precoma diabetica, or diabetic coma
- Treatment with any other investigational drug within the last three months before Screening
- Acute infections within the last four weeks prior to Screening
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 |
|---|---|---|
| Dapagliflozin 10 mg + Saxagliptin 5 mgAlso: Forxiga + Onglyza24 weeks intervention with Dapagliflozin 10 mg + Saxagliptin 5 mg | Drug | Verum |
| Placebo 1 10 mg + Placebo 2 5 mgAlso: Placebo 1 + Placebo 224 weeks intervention with Placebo 1 10 mg + Placebo 2 5 mg | Drug | Placebo |
Primary outcome
Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen
Time frame: 24 weeks
Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen with treatment of dapagliflozin/saxagliptin or placebo
14 secondary outcomes
changes in HbA1c between groups
Time frame: 24 weeks
changes in hypoglycaemic events between groups
Time frame: 24 weeks
changes in fasting blood glucose between groups
Time frame: 24 weeks
changes in daily insulin dose between groups
Time frame: 24 weeks
changes in bodyweight between groups
Time frame: 24 weeks
changes in body fat content between groups
Time frame: 24 weeks
changes in body fat distribution between groups
Time frame: 24 weeks
changes in liver fat content between groups
Time frame: 24 weeks
changes in intra-nasal insulin-induced brain fMR (functional magnetic resonance) imaging results between groups
Time frame: 24 weeks
changes in blood pressure between groups
Time frame: 24 weeks
changes in the blood lipid profile between groups
Time frame: 24 weeks
changes in microalbuminuria between groups
Time frame: 24 weeks
changes in well being and disease perception between groups
Time frame: 24 weeks
changes in fear of hypoglycemia between groups
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Low patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dapagliflozin 10 mg + Saxagliptin 5 mg in people with Type 2 Diabetes, run by University Hospital Tuebingen at 1 site in Germany.
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 27 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: stopped early, as of the sponsor's last update on 11 Feb 2020. 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 Germany. 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 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?
The study was stopped early (reason given: Low patient recruitment). Results are not available in the source record.
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?
Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen (time frame: 24 weeks). 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 11 Feb 2020.