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

• Status: Terminated
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GWT-TUD GmbH
• Treatments: Glimepiride; Metformin; Sitagliptin Phosphate

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