Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients

NCT03359590 | Completed Phase 2 Results

• 1 other identifier: DPP4-Hypo
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sitagliptin arm

EXPERIMENTAL

Sitagliptin 100 mg

Drug: Sitagliptin 100 mg

Placebo arm

PLACEBO COMPARATOR

Placebo comparator

Drug: Placebo

Interventions

Sitagliptin 100 mg DRUG

The treatment consists of sitagliptin tablets (100 mg/day) for up to 24 weeks.

Sitagliptin arm

Placebo DRUG

The treatment consists of placebo tablets for up to 24 weeks.

Placebo arm

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subject with diabetes mellitus type 2.
• Age between 18 and 64 years, both inclusive.
• HbA1c \<= 8.5%.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Profil Institut für Stoffwechselforschung GmbH: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Location

MeSH Terms

Interventions

Sitagliptin Phosphate

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Dr. Christoph Kapitza
• Organization: Profil Institut für Stoffwechselforschung GmbH

christoph.kapitza@profil.com

+49 2131 4018

Study Officials

• Christoph Kapitza, MD

  Profil GmbH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind randomised trial. Except for the unblinded persons involved in the preparation of the IMP (these persons are not involved in any other trial activities), everyone involved in the trial will be blinded until completion of the trial and the final data review.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a postmarketing phase 2 trial. The trial is designed as single centre, randomised, double blind, two-way treatment, placebo controlled crossover trial in subjects with type 2 diabetes mellitus treated to fasting plasma glucose targets with insulin glargine and metformin.

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: December 2, 2017
• Study Start: March 21, 2018
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Locations

DE (1)