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

NCT ID: NCT01547104

Last Updated: 2012-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-10-31

Brief Summary

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.

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.

Conditions

Diabetes Mellitus Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Glimepiride-ratiopharm

Glimepiride (1-4mg) as add on therapy

Group Type: ACTIVE_COMPARATOR

Glimepiride

Intervention Type: DRUG

Glimepiride 1-4mg (individually dosed) as add on therapy to an existing metformin therapy

Trajenta

Linagliptin 5 mg as add on therapy

Group Type: EXPERIMENTAL

Linagliptin

Intervention Type: DRUG

Linagliptin dosed 5 mg as add on therapy to an existing metformin therapy

Interventions

Linagliptin

Linagliptin dosed 5 mg as add on therapy to an existing metformin therapy

Intervention Type: DRUG

Glimepiride

Glimepiride 1-4mg (individually dosed) as add on therapy to an existing metformin therapy

Intervention Type: DRUG

Other Intervention Names

Glimepirid-ratiopharm

Eligibility Criteria

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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ikfe-CRO GmbH

INDUSTRY

Sponsor Role: collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Marcus Borchert

INDUSTRY

Sponsor Role: lead

Responsible Party

Marcus Borchert

Prof. Dr. Thomas Forst

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas Forst, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ikfe GmbH

Locations

ikfe GmbH

Mainz, Rhineland-Palatinate, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Thomas Forst, MD, PhD

Role: CONTACT

ThomasF@ikfe.de

+ 49 6131 57636 ext. 16

Claudia Forkel

Role: CONTACT

C.Forkel@ikfe-cro.de

+ 49 6131 32790 ext. 32

Facility Contacts

Thomas Forst, MD, PhD

Role: primary

ThomasF@ikfe.de

+ 49 6131 57636 ext. 16

Daniela Sachsenheimer, MD

Role: backup

DanielaS@ikfe.de

+ 49 6131 57636 ext. 46

Other Identifiers

2012-000179-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ikfe-Lina-002

Identifier Type: -

Identifier Source: org_study_id