Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes

October 19, 2018 updated by: GWT-TUD GmbH

Randomized Double Blind Parallel Design Study Comparing Risk of Nocturnal Hypoglycemia and Critical Arrhythmia With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes Insufficiently Controlled With Metformin Monotherapy

This exploratory double blind randomized active controlled study is designed to assess the effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage of glimepiride as add on therapy in patients with diabetes mellitus type 2 (T2DM) patients inadequately controlled on metformin monotherapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Type 2 Diabetes is associated with an increased cardiovascular morbidity and mortality. Among patients insufficiently controlled with metformin multimorbidity and polypharmacy is common that makes the patients frail for cardiovascular complications related to hypoglycemic events.

This exploratory double blind randomized active controlled study is designed to assess the effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage of glimepiride as add on therapy in patients with T2DM patients inadequately controlled on metformin monotherapy.

Examinations will be performed as a 5 day recording of subcutaneous glucose concentration (CGMS) and holder ECG (AMEDTEC) at baseline and after a 12 weeks treatment with sitagliptin or glimepiride as active comparators used in combination with metformin.

With recording of nocturnal hypoglycemia and arrhythmias it is aimed to evaluate favorable glycemic profile under treatment with sitagliptin compared to glimepiride. The primary objective is risk of serious HE for both drugs.

The glycemic profile of sitagliptin as add-on therapy to metformin seems to be favorable compared to sulfonylureass such as glimepiride. Treatment with sitagliptin as add-on to metformin therapy causes less glycemic fluctuations and may be associated with lower oxidative stress and down regulation of low grade inflammation. This hypothesis will be tested as an explorative double blind study.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • GWT-TUD GmbH / Studienzentrum Hanefeld

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • type 2 diabetes
  • age 40-80 years
  • stable dose of ≥ 1500 mg metformin or maximal tolerated dose of metformin for > 6 weeks
  • HbA1c ≥ 7 % - ≤ 9.0% for age < 65 years and ≥ 7.5 % - ≤ 9.0% for age ≥ 65 years
  • able and trained to perform SMBG
  • the informed consent form must be signed before any study specific tests or procedures are done
  • ability to understand and follow study-related instructions

Exclusion Criteria:

  • Type 1 diabetes
  • previous treatment with insulin, GLP1 analogues and SU in < 6 month
  • HbA1c > 9 % or FPG > 15 mmol/l at randomization
  • renal impairment with eGFR < 60 ml/min
  • medical history of severe hypoglycemia defined as necessity of medical assistance in < 1 year
  • major cardiovascular event (MACE) in medical history < 6 months
  • preexisting atrial fibrillation, , AV block ≥II degree, pace-maker, implanted defibrillator
  • major cardiovascular event in medical history < 6 months
  • heart failure NYHA ≥ III
  • contraindications to glimepiride and sitagliptin or to any excipients according to product information
  • severe cognitive deficits
  • Patients who are disable to read and understand informative aspects of the trial
  • Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s)
  • Inability to comply with study procedures
  • Pregnant or breast-feeding woman and woman without adequate method of contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Patients receiving Sitagliptin 100 mg+ Glimepiride-placebo (adapted dosage)
Drug: Sitagliptin
Sitagliptin will be given in a daily dosage of 100 mg
Drug: Glimepiride-Placebo
Glimepiride-Placebo will be given additional to Sitagliptin (blinded). It will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg
Active Comparator: Arm B
Glimepiride (adapted dosage) + Sitagliptin 100 mg Placebo
Drug: Glimepiride
Glimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg
Drug: Sitagliptin-Placebo
Sitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Hypoglycemic Episodes (HE) Under Treatment With Sitagliptin Compared to Glimepiride
Time Frame: 12 weeks (at baseline and at EOT)
measurement of hypoglycemic episodes including event duration at baseline and EOT after 12 weeks of treatment and measurement of time spent below critical values for hypoglycemic episodes are the primary objectives of this study. We will calculate overall episodes/time (5 days) and nocturnal episodes.
12 weeks (at baseline and at EOT)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence and Number of Nocturnal Ventricular Arrhythmias
Time Frame: 12 weeks (at baseline and at EOT)
measurement of nocturnal ventricular arrhythmias at baseline and EOT (after 12 weeks of treatment) - per patient, couplets per patient, triplets per patient)
12 weeks (at baseline and at EOT)
Glycemic Variability (Profile) of Sitagliptin Compared to Glimepiride
Time Frame: 12 weeks (at baseline and at EOT)
The glycemic profile is defined as the area under the glucose-timeprofile obtained by continuous glucose monitoring (5 days baseline and 5 days after 12 weeks of each treatment)
12 weeks (at baseline and at EOT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GWT-TUD GmbH

Investigators

  • Study Director: Markolf Hanefeld, Prof. Dr., GWT-TUD GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

February 22, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIA-2-REDESIGN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus Type 2

Clinical Trials on Sitagliptin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe