Phase 4
N=28
Sitagliptin and Glucagon Counterregulation
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02256189 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Glucagon Counterregulation to Hypoglycemia — 16.0; 16.5 pmol/l
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sitagliptin (Drug); Placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Lund University
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucagon Counterregulation to Hypoglycemia |
16.0; 16.5 | — |
Summary
To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at moderate hypoglycemia in metformin-treated subjects with T2DM
Eligibility Criteria
Inclusion Criteria
- Written consent has been given.
- Patients with metformin treated T2DM (metformin dose >0,5 g/day and stable during the preceding 3 months)
- Age >65 years.
- HbA1c 6.0-8.5% (43-67 mmol/mol; inclusive) at visit 1.
- Ability to complete the study
Exclusion Criteria
- A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
- Type 2 diabetes, positive GAD antibodies
- eGFR 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
Data sourced from ClinicalTrials.gov (NCT02256189). 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.