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

NCT02373865 | Terminated Phase 4 Results

• 1 other identifier: DIA-2-REDESIGN
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes mellitus type 2; nocturnal hypoglycemia; metformin monotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Hypoglycemic Episodes (HE) Under Treatment With Sitagliptin Compared to Glimepiride

  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.

  12 weeks (at baseline and at EOT)

Secondary Outcomes (2)

• Occurence and Number of Nocturnal Ventricular Arrhythmias

  12 weeks (at baseline and at EOT)

• Glycemic Variability (Profile) of Sitagliptin Compared to Glimepiride

  12 weeks (at baseline and at EOT)

Study Arms (2)

Arm A

EXPERIMENTAL

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

Drug: Sitagliptin; Drug: Glimepiride-Placebo

Arm B

ACTIVE COMPARATOR

Glimepiride (adapted dosage) + Sitagliptin 100 mg Placebo

Drug: Glimepiride; Drug: Sitagliptin-Placebo

Interventions

Sitagliptin DRUG

Sitagliptin will be given in a daily dosage of 100 mg

Arm A

Glimepiride DRUG

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

Arm B

Sitagliptin-Placebo DRUG

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

Arm B

Glimepiride-Placebo 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 A

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GWT-TUD GmbH: lead

Study Sites (1)

GWT-TUD GmbH / Studienzentrum Hanefeld

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Limitations and Caveats

Limitations of the study: deceleration of patient recruitment, break up of patient recruitment, descriptive reporting of patient characteristics of 4 enrolled patients (no statistically reliable results are available)

Results Point of Contact

• Title: Prof. Dr. Markolf Hanefeld
• Organization: GWT-TUD GmbH, Study center Prof. Hanefeld

Markolf.Hanefeld@gwtonline.de

+49 351 44005

Study Officials

• Markolf Hanefeld, Prof. Dr.

  GWT-TUD GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: February 27, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 27, 2019
• Results First Posted: February 27, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)