NCT03359590

Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients

DPP-4 Inhibition With Sitagliptin and the Risk for Hypoglycaemia in the Fasting State in Subjects With Type 2 Diabetes Treated to Fasting Plasma Glucose Targets With Insulin Glargine and Metformin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Profil Institut für Stoffwechselforschung GmbH · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pharmacological Action

Interventions

Type	Name	Description
DRUG	Sitagliptin 100 mg	The treatment consists of sitagliptin tablets (100 mg/day) for up to 24 weeks.
DRUG	Placebo	The treatment consists of placebo tablets for up to 24 weeks.

Timeline

• Start date: 2018-03-21
• Primary completion: 2019-07-17
• Completion: 2019-07-17
• First posted: 2017-12-02
• Last updated: 2021-02-21
• Results posted: 2021-02-21

Locations

1 site across 1 country: Germany