Phase 4
N=28
Vildagliptin Versus Dapagliflozin on Glucagon
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02475070 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Glucagon Response to Meal — 39.0; 38.8 nmol/l min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vildagliptin (Drug); Dapagliflozin (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Lund University
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucagon Response to Meal |
39.0; 38.8 | — |
| SECONDARY Incretin Hormones |
3.8; 3.7 | — |
Summary
The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2 diabetes and whether this is associated with effects on glucose homeostasis.
Eligibility Criteria
Inclusion Criteria
- Written consent has been given.
- Patients with type 2 diabetes treated with a stable dose of metformin during the last three months
- Age 20-70 years.
- HbA1c 6.5-8.5% (48-67 mmol/mol) at visit 1.
- Ability to complete the study
Exclusion Criteria
- Use of other glucose-lowering therapy than metformin within three months prior to visit 1.
- A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
- Type 1 diabetes, positive GAD antibodies
- Estimated glomerular filtration rate 7 consecutive days of treatment) within 8 weeks prior to visit 1.
- Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
- Hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core
Data sourced from ClinicalTrials.gov (NCT02475070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.