RISK OF NOCTURNAL HYPOGLYCEMIA AND CRITICAL ARRHYTHMIAS WITH SITAGLIPTIN VERSUS GLIMEPIRIDE IN PATIENTS WITH TYPE 2 DIABETES

RANDOMIZED DOUBLE BLIND PARALLEL DESIGN STUDY COMPARING RISK OF NOCTURNAL HYPOGLYCEMIA AND CRITICAL ARRHYTHMIAS WITH SITAGLIPTIN VERSUS GLIMEPIRIDE IN PATIENTS WITH TYPE 2 DIABETES INSUFFICIENTLY CONTROLLED WITH METFORMIN MONOTHERAPY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003792-34-DE

Enrollment

Unknown

Registered

2014-11-27

Start date

2015-03-25

Completion date

Unknown

Last updated

2017-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with diabetes mellitus type 2 inadequately controlled on metformin monotherapy

Interventions

Product Name: Sitagliptin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Sitagliptin CAS Number: 654671-77-9 Other descriptive name: SITAGLIPTIN Concentration unit: mg milligram(s) Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - type 2 diabetes - age 40-80 years - stable dose of = 1500 mg metformin for > 6 weeks - HbA1c = 7 % - = 9.0% for age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Type 1 diabetes previous treatment with insulin, GLP1 analogues and SU - HbA1c > 9 % or FPG > 15 mmol/l at randomization - renal impairment with eGFR < 60 ml/min - medical history of severe hypoglycemia < 1 year - preexisting atrial fibrillation, absolute ventricular arrhythmia, AV block III degree, pace-maker - major cardiovascular event in medical history < 6 months - heart failure NYHA = 3 - contraindications to glimepiride and sitagliptin or to any excipients according to product information - acute infection diseases - cognitive deficits - Pregnant or breast-feeding woman and woman without adequate method of contraception. - Patients who are disable to read and understand informative aspects of the trial

Design outcomes

Primary

Measure	Time frame
Main Objective: Hypoglycemic episodes (HE) and time spent below critical values are the primary objectives of this study. We will calculate overall episodes/time (5 days) and nocturnal episodes. Analysis will be performed as change between baseline and EOT by group and between group comparison at study end for CGMS and ECG results.;Secondary Objective: - overall VES (per patient, couplets per patient, triplets per patient) - VT per patient - glycemic variability - biomarkers of inflammation - cardiovascular risk factors Analysis will be performed as change between baseline and EOT by group and between group comparison at study end for CGMS and ECG results.;Primary end point(s): - Hypoglycemic episodes and time of episodes;Timepoint(s) of evaluation of this end point: Analysis will be performed as change between baseline (Week 0) and EOT (week 12 +/-3days) by group and between group comparison at study end for CGMS and ECG results.	—

Measure

Time frame

Main Objective: Hypoglycemic episodes (HE) and time spent below critical values are the primary objectives of this study. We will calculate overall episodes/time (5 days) and nocturnal episodes. Analysis will be performed as change between baseline and EOT by group and between group comparison at study end for CGMS and ECG results.;Secondary Objective: - overall VES (per patient, couplets per patient, triplets per patient) - VT per patient - glycemic variability - biomarkers of inflammation - cardiovascular risk factors Analysis will be performed as change between baseline and EOT by group and between group comparison at study end for CGMS and ECG results.;Primary end point(s): - Hypoglycemic episodes and time of episodes;Timepoint(s) of evaluation of this end point: Analysis will be performed as change between baseline (Week 0) and EOT (week 12 +/-3days) by group and between group comparison at study end for CGMS and ECG results.

—

Secondary

Measure	Time frame
Secondary end point(s): - nocturnal ventricular arrhythmias - glycemic variability - biomarkers of inflammation - cardiovascular risk factors;Timepoint(s) of evaluation of this end point: Analysis will be performed as change between baseline (Week 0) and EOT (week 12 +/-3days) by group and between group comparison at study end for CGMS and ECG results.	—

Countries

Germany

Contacts

Public ContactKatja Reichardt

GWT-TUD GmbH

katja.reichardt@gwtonline.de004935125933188

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026