Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients

Pharmacological Action Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359590
• Other study ID #: DPP4-Hypo
• Status: Completed
• Phase: Phase 2
• Start date: March 21, 2018
• Est. completion date: July 17, 2019

Study information

• Verified date: February 2021
• Source: Profil Institut für Stoffwechselforschung GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 17, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male or female subject with diabetes mellitus type 2.
• Age between 18 and 64 years, both inclusive.
• HbA1c <= 8.5%.
• Stable treatment with insulin glargine (any dose) and metformin (>= 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.

Related Conditions & MeSH terms

• Hypoglycemia
• Pharmacological Action

Intervention

Drug:
• Sitagliptin 100 mg
The treatment consists of sitagliptin tablets (100 mg/day) for up to 24 weeks.
• Placebo
The treatment consists of placebo tablets for up to 24 weeks.

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (2)

Lead Sponsor	Collaborator
Profil Institut für Stoffwechselforschung GmbH	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Frequency of Hypoglycaemic Episodes With Sitagliptin vs Placebo Treatment.	The purpose of the trial was to test the influence of DPP-4 inhibition on the risk to develop hypoglycaemia. Chemical hypoglycaemic episodes (characterised by a plasma glucose nadir =70 mg/dL) occurring during the in-house periods of the subjects were compared.	during the two in-house periods (54 hs each) after treatment with sitagliptin or placebo for up to 24 weeks