Effect of Linagliptin in Comparison With Glimepiride as Add on to Metformin on Postprandial Beta Cell Function, Postprandial Metabolism and Oxidative Stress in Patients With Type 2 Diabetes Mellitus

April 10, 2012 updated by: Marcus Borchert
The goal of this mechanistic study is to investigate the effect of Linagliptin in comparison to Glimepiride as add on therapy on several parameters characterizing postprandial metabolism and oxidative stress in type 2 diabetic patients on stable control with metformin.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this mechanistic study is to investigate the effect of Linagliptin in comparison to Glimepiride as add on therapy on several parameters characterizing postprandial metabolism and oxidative stress in type 2 diabetic patients on stable control with metformin.

This mechanistic phase IV study has a prospective, comparative, open, randomized, two arm and exploratory design. Overall 40 Patients will be randomized to two treatment arms both receiving Metformin at a maximally tolerated dose. In addition to that both treatment groups will receive either an individually titrated dose of Glimepiride or 5mg once daily of Linagliptin. Subsequent to a standardized meal, several parameters reflecting beta cell function, metabolism and oxidative stress will be evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Thomas Forst, MD, PhD
  • Phone Number: 16 + 49 6131 57636
  • Email: ThomasF@ikfe.de

Study Contact Backup

Study Locations

  • Germany
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55116
        • Recruiting
        • IKFE GmbH
        • Contact:
          • Thomas Forst, MD, PhD
          • Phone Number: 16 + 49 6131 57636
          • Email: ThomasF@ikfe.de
        • Contact:
          • Daniela Sachsenheimer, MD
          • Phone Number: 46 + 49 6131 57636
          • Email: DanielaS@ikfe.de
        • Sub-Investigator:
          • Stefan Diessel
        • Sub-Investigator:
          • Michael Mitry, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diabetes mellitus type 2
  2. HbA1c > 6.5% - ≤ 8.5%
  3. HbA1c > 7.0% - ≤ 8.5% for those patients with a significant cardiovascular history
  4. Treatment with metformin at a maximum tolerated dose
  5. Age 45 - 75 years (inclusively)
  6. Patient consents that his/her family physician/diabetologist will be informed of trial participation.

Exclusion Criteria:

  1. Pretreatment with PPAR gamma agonists within the last three months
  2. History of type 1 diabetes
  3. Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg)
  4. Acute infections
  5. Medical history of hypersensitivity to the study drugs or to drugs with similar chemical structures
  6. History of severe or multiple allergies
  7. Treatment with any other investigational drug within 3 months before trial entry.
  8. Progressive fatal disease
  9. History of drug or alcohol abuse in the past 2 years
  10. State after kidney transplantation
  11. Serum potassium > 5.5 mmol/L
  12. Pregnancy or breast feeding
  13. Sexually active woman of childbearing age not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomized partner.
  14. Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous 30 days
  15. Any elective surgery during study participation
  16. Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit
  17. History of pancreatitis
  18. History of dehydration, pre-coma diabeticum or diabetic ketoacidosis
  19. Acute or scheduled investigation with iodine containing radiopaque material
  20. Uncontrolled unstable angina pectoris
  21. History of pericarditis, myocarditis, endocarditis
  22. Recent pulmonary embolism
  23. Hemodynamic relevant aortic stenosis
  24. Aortic aneurysm
  25. Regular use of NSAID's (no acute use of NSAID within 48 hours before V2,V4,V5)
  26. Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
  27. History of respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (Creatinine > 1.1 mg/dl in women and > 1.5 mg/dl in men ), neurological, psychiatric and/or hematological disease as judged by the investigator
  28. Lactose intolerance
  29. Intake of Coumarin or coumarin derived compounds such as phenprocoumon (Marcumar) or warfarin (Coumadin, Warfant)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Glimepiride-ratiopharm
Glimepiride (1-4mg) as add on therapy
Drug: Glimepiride
Glimepiride 1-4mg (individually dosed) as add on therapy to an existing metformin therapy
Other Names:
  • Glimepirid-ratiopharm
Experimental: Trajenta
Linagliptin 5 mg as add on therapy
Drug: Linagliptin
Linagliptin dosed 5 mg as add on therapy to an existing metformin therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Postprandial increase in intact Proinsulin levels (Peak, AUC)
Time Frame: 30, 60, 90, 120, 150, 180, 210, 240, 270 300 mins post test meal procedure, 3 times within 12 weeks treatment
30, 60, 90, 120, 150, 180, 210, 240, 270 300 mins post test meal procedure, 3 times within 12 weeks treatment
Postprandial Proinsulin/Insulin Ratio
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Fasting intact Proinsulin levels
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Fasting Proinsulin/Insulin Ratio
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Fasting Blood Glucose
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Postprandial Blood Glucose Excursions (Peak; AUC)
Time Frame: 30, 60, 90, 120, 150, 180, 210, 240, 270 300 mins post test meal procedure, 3 times within 12 weeks treatment
30, 60, 90, 120, 150, 180, 210, 240, 270 300 mins post test meal procedure, 3 times within 12 weeks treatment
Fasting Lipids
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Postprandial Lipids
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Fasting Erythrocyte Flexibility
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Postprandial Erythrocyte Flexibility
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Fasting GLP-1 levels
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Postprandial GLP-1 levels
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Fasting cGMP
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Postprandial cGMP
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Fasting Calcitonin
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Fasting PAI-1 levels
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Postprandial PAI-1 levels
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Fasting ADMA levels
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Postprandial ADMA levels
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Fasting Malonyldialdehyd
Time Frame: after 12 weeks treatment
after 12 weeks treatment
fasting oxidatively modified nucleosides 8-oxodG and 8-oxoGuo
Time Frame: after 12 weeks treatment
after 12 weeks treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Hypoglycemic events
Time Frame: after 12 weeks treatment
after 12 weeks treatment
Body Weight
Time Frame: after 12 weeks treatment
after 12 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marcus Borchert

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boehringer Ingelheim
ikfe-CRO GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Forst, MD, PhD, IKFE GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ikfe-Lina-002
  • 2012-000179-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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