Semaglutide and Dapagliflozin in Diabetic Patients With Different Pathophysiology
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|ClinicalTrials.gov Identifier: NCT04451837|
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : July 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Type2 Diabetes||Drug: Semaglutide Drug: Dapagliflozin||Phase 2|
The trial is a clinical phase II study that will be randomized and open-label with fixed stratification variables (SIDD and SIRD) to analyze if the response to anti-diabetic drugs differs between patients with distinct pathophysiology, as captured by SIDD and SIRD. The compounds used are semaglutide and dapagliflozin, which will be randomized to patients of each subgroup using a parallel group design.
The clusters (SIDD and SIRD) will be used as a practical tool to distinguish individuals who are at different ends of the pathophysiological spectrum.
The investigators will recruit 200 patients from the ANDIS registry with HbA1c ≥48 mmol/mol on metformin monotherapy. Half of them will have SIDD and half will have SIRD characteristics. The patients will be randomized (open-label) to receive semaglutide or dapagliflozin for six months in addition to metformin.
The investigators will recruit participants on metformin monotherapy with stable dose for the last three months. Metformin dose at inclusion (as prescribed by their regular physician) is maintained throughout the study; the investigatorswill correct for metformin dose in the analyses. Patients randomized to add semaglutide will receive injection training at the study site and inject 0.25 mg subcutaneously once weekly during the first four weeks, followed by 0.5 mg weekly for the subsequent four weeks and finally 1.0 mg weekly throughout the study. Those randomized to dapagliflozin will receive 10 mg orally once daily in addition to metformin. The participants will attend a screening visit followed by three study visits at 0, 3, 6 months. At the first and last study visit they will undergo an OGTT. HbA1c will be measured at all study visits.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Semaglutide and Dapagliflozin in Diabetic Patients With Different Pathophysiology|
|Actual Study Start Date :||June 15, 2020|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Active Comparator: semaglutide
Patients randomized to add semaglutide (Ozempic) will receive injection training at the study site and inject 0.25 mg subcutaneously once weekly during the first four weeks, followed by 0.5 mg weekly for the subsequent four weeks and finally 1.0 mg weekly throughout the study.
Ozempic s.c. once weekly for 6 months
Other Name: Ozempic
Active Comparator: dapagliflozin
Those randomized to dapagliflozin will receive 10 mg orally once daily in addition to metformin.
Forxiga 10 mg p.o. once daily for 6 months
Other Name: Forxiga
- Hba1c [ Time Frame: 6 months ]The primary endpoint will be the intraindividual change of HbA1c in response to semaglutide or dapagliflozin relative to baseline in the two patient groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451837
|Contact: Anders Rosengrenemail@example.com|
|Malmö, Skane, Sweden, 20502|
|Contact: Anders Rosengren, Professor 0705316704 firstname.lastname@example.org|
|Principal Investigator:||Anders Rosengren||Region Skåne|