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

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ClinicalTrials.gov Identifier: NCT02373865
Recruitment Status : Terminated (Premature termination due to insufficient patient recruitement..)
First Posted : February 27, 2015
Results First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
GWT-TUD GmbH

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Sitagliptin Drug: Glimepiride Drug: Sitagliptin-Placebo Drug: Glimepiride-Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
Patients receiving Sitagliptin 100 mg+ Glimepiride-placebo (adapted dosage)
Drug: Sitagliptin
Sitagliptin 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

Active Comparator: Arm B
Glimepiride (adapted dosage) + Sitagliptin 100 mg Placebo
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




Primary Outcome Measures :
  1. Number of Hypoglycemic Episodes (HE) Under Treatment With Sitagliptin Compared to Glimepiride [ Time Frame: 12 weeks (at baseline and at EOT) ]
    measurement of hypoglycemic episodes including event duration at baseline and EOT after 12 weeks of treatment and measurement of time spent below critical values for hypoglycemic episodes are the primary objectives of this study. We will calculate overall episodes/time (5 days) and nocturnal episodes.


Secondary Outcome Measures :
  1. Occurence and Number of Nocturnal Ventricular Arrhythmias [ Time Frame: 12 weeks (at baseline and at EOT) ]
    measurement of nocturnal ventricular arrhythmias at baseline and EOT (after 12 weeks of treatment) - per patient, couplets per patient, triplets per patient)

  2. Glycemic Variability (Profile) of Sitagliptin Compared to Glimepiride [ Time Frame: 12 weeks (at baseline and at EOT) ]
    The glycemic profile is defined as the area under the glucose-timeprofile obtained by continuous glucose monitoring (5 days baseline and 5 days after 12 weeks of each treatment)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373865


Locations
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Germany
GWT-TUD GmbH / Studienzentrum Hanefeld
Dresden, Germany, 01307
Sponsors and Collaborators
GWT-TUD GmbH
Investigators
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Study Director: Markolf Hanefeld, Prof. Dr. GWT-TUD GmbH
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Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT02373865    
Other Study ID Numbers: DIA-2-REDESIGN
First Posted: February 27, 2015    Key Record Dates
Results First Posted: February 27, 2019
Last Update Posted: February 27, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by GWT-TUD GmbH:
Diabetes mellitus type 2
nocturnal hypoglycemia
metformin monotherapy
Additional relevant MeSH terms:
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Diabetes Mellitus
Hypoglycemia
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Glimepiride
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors