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

NCT ID: NCT02373865

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-01-31

Brief 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.

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.

Conditions

Diabetes Mellitus Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm A

Patients receiving Sitagliptin 100 mg+ Glimepiride-placebo (adapted dosage)

Group Type: EXPERIMENTAL

Sitagliptin

Intervention Type: DRUG

Sitagliptin will be given in a daily dosage of 100 mg

Glimepiride-Placebo

Intervention Type: DRUG

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

Arm B

Glimepiride (adapted dosage) + Sitagliptin 100 mg Placebo

Group Type: ACTIVE_COMPARATOR

Glimepiride

Intervention Type: DRUG

Glimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg

Sitagliptin-Placebo

Intervention Type: DRUG

Sitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg

Interventions

Sitagliptin

Sitagliptin will be given in a daily dosage of 100 mg

Intervention Type: DRUG

Glimepiride

Glimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg

Intervention Type: DRUG

Sitagliptin-Placebo

Sitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GWT-TUD GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markolf Hanefeld, Prof. Dr.

Role: STUDY_DIRECTOR

GWT-TUD GmbH

Locations

GWT-TUD GmbH / Studienzentrum Hanefeld

Dresden, , Germany

Countries

Germany

Other Identifiers

DIA-2-REDESIGN

Identifier Type: -

Identifier Source: org_study_id