Phase 2
N=20
Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients
Pharmacological Action
Bottom Line
View on ClinicalTrials.gov: NCT03359590 ↗Enrolled (actual)
20
Serious AEs
2.8%
Results posted
Feb 2021
Primary outcome: Primary: The Frequency of Hypoglycaemic Episodes With Sitagliptin vs Placebo Treatment. — 5.35; 5.72 Hypoglycaemic episodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sitagliptin 100 mg (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Frequency of Hypoglycaemic Episodes With Sitagliptin vs Placebo Treatment. |
5.35; 5.72 | — |
Summary
Sitagliptin, through its effects on sensitizing alpha-cell sensitivity to glucose, can initiate counter-regulatory glucagon responses at higher glycemic thresholds, thus reducing the number of clinically apparent hypoglycemic episodes, and/or ameliorating the severity of hypoglycemic episodes in the case that they should occur. The endpoints have defined such that consequences of this hypothesis can be measured.
Eligibility Criteria
Inclusion Criteria
- Male or female subject with diabetes mellitus type 2.
- Age between 18 and 64 years, both inclusive.
- HbA1c = 1500 mg/day or at highest tolerated dose) for at least 3 months prior to inclusion into the trial with or without additional oral glucose-lowering agents (except thiazolidinediones).
- Considered generally healthy (apart from diabetes mellitus type 2 and associated conditions such as hypertension, hyperlipidaemia and hyperuricaemia) upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator.
Exclusion Criteria
- Known or suspected hypersensitivity to sitagliptin or related products.
- More than one episode of severe hypoglycaemia with seizure, coma or requiring medical assistance of another person during the past 6 months or hypoglycaemic unawareness as judged by the Investigator.
- Current or previous treatment (less than 3 months prior to screening) with insulin products other than insulin glargine and/or with Glucagon-like peptide (GLP) 1 receptor agonists and/or with thiazolidinediones.
- Unwillingness to wash-off any oral glucose-lowering agents other than metformin.
Data sourced from ClinicalTrials.gov (NCT03359590). 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.