Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-21

Study Completion Date

2019-07-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sitagliptin and Glucagon Counterregulation

NCT02256189

Type 2 Diabetes

COMPLETED PHASE4

Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)

NCT00875394

Diabetes Mellitus, Non-Insulin-Dependent

COMPLETED PHASE3

Effectiveness of Sitagliptin in Glycemic Control in Real World

NCT01316835

Type 2 Diabetes Mellitus

UNKNOWN

Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

NCT00758069

Diabetes Mellitus, Non-Insulin-Dependent

COMPLETED PHASE2

Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus

NCT00337610

Type 2 Diabetes Mellitus (T2DM)

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pharmacological Action

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sitagliptin arm

Sitagliptin 100 mg

Group Type EXPERIMENTAL

Sitagliptin 100 mg

Intervention Type DRUG

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

Placebo arm

Placebo comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sitagliptin 100 mg

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No