Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes
Information source: GWT-TUD GmbH
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus Type 2
Intervention: Sitagliptin (Drug); Glimepiride (Drug); Sitagliptin-Placebo (Drug); Glimepiride-Placebo (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: GWT-TUD GmbH Official(s) and/or principal investigator(s): Markolf Hanefeld, Prof. Dr., Study Director, Affiliation: GWT-TUD GmbH
Overall contact: Katja Reichardt, Dr., Phone: +49 351 25933, Ext: 188, Email: katja.reichardt@gwtonline.de
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: number of hypoglycemic episodes (HE) under treatment with sitagliptin compared to glimepiride
Secondary outcome: occurence and number of nocturnal ventricular arrhythmiasglycemic variability (profile) of sitagliptin compared to glimepiride
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.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Katja Reichardt, Dr., Phone: +49 351 25933, Ext: 188, Email: katja.reichardt@gwtonline.de
GWT-TUD GmbH / Studienzentrum Hanefeld, Dresden 01307, Germany
Additional Information
Starting date: April 2015
Last updated: February 22, 2015
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