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Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients

Primary Purpose

Pharmacological Action

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Sitagliptin 100 mg

Placebo

About this trial

This is an interventional treatment trial for Pharmacological Action

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Profil Institut für Stoffwechselforschung GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sitagliptin arm

Placebo arm

Arm Description

Sitagliptin 100 mg

Placebo comparator

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03359590

First Posted

November 24, 2017

Last Updated

February 2, 2021

Sponsor

Profil Institut für Stoffwechselforschung GmbH

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT03359590

Brief Title

Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

March 21, 2018 (Actual)

Primary Completion Date

July 17, 2019 (Actual)

Study Completion Date

July 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Profil Institut für Stoffwechselforschung GmbH

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pharmacological Action

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sitagliptin arm

Arm Type

Experimental

Arm Description

Sitagliptin 100 mg

Arm Title

Placebo arm

Arm Type

Placebo Comparator

Arm Description

Placebo comparator

Intervention Type

Drug

Intervention Name(s)

Sitagliptin 100 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

The Frequency of Hypoglycaemic Episodes With Sitagliptin vs Placebo Treatment.

Description

Time Frame

during the two in-house periods (54 hs each) after treatment with sitagliptin or placebo for up to 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph Kapitza, MD

Organizational Affiliation

Profil GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Profil Institut für Stoffwechselforschung GmbH

City

Neuss

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients

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