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Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients

NCT03359590 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-02-21

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Christoph Kapitza, MD · Profil GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-21
Primary Completion
2019-07-17
Completion
2019-07-17

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03359590 on ClinicalTrials.gov