Trials / Terminated
TerminatedNCT02965443
Dapagliflozin + Saxagliptin in a Basal-bolus Insulin Treatment
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
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- University Hospital Tuebingen · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dapagliflozin 10 mg + Saxagliptin 5 mg | 24 weeks intervention with Dapagliflozin 10 mg + Saxagliptin 5 mg |
| DRUG | Placebo 1 10 mg + Placebo 2 5 mg | 24 weeks intervention with Placebo 1 10 mg + Placebo 2 5 mg |
Timeline
- Start date
- 2018-02-02
- Primary completion
- 2020-02-03
- Completion
- 2020-02-03
- First posted
- 2016-11-16
- Last updated
- 2020-02-11
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02965443. Inclusion in this directory is not an endorsement.