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

NCT02373865 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-02-27

Study results available
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Summary

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.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

Sitagliptin

Sitagliptin will be given in a daily dosage of 100 mg

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

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

Sponsors & Collaborators

  • GWT-TUD GmbH

    lead OTHER

Principal Investigators

  • Markolf Hanefeld, Prof. Dr. · GWT-TUD GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02373865 on ClinicalTrials.gov