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

NCT01547104 | Unknown Phase 4

• 2 other identifiers: ikfe-Lina-0022012-000179-17
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (21)

• Postprandial increase in intact Proinsulin levels (Peak, AUC)

  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

  after 12 weeks treatment

• Fasting intact Proinsulin levels

  after 12 weeks treatment

• Fasting Proinsulin/Insulin Ratio

  after 12 weeks treatment

• Fasting Blood Glucose

  after 12 weeks treatment

• Postprandial Blood Glucose Excursions (Peak; AUC)

  30, 60, 90, 120, 150, 180, 210, 240, 270 300 mins post test meal procedure, 3 times within 12 weeks treatment

• Fasting Lipids

  after 12 weeks treatment

• Postprandial Lipids

  after 12 weeks treatment

• Fasting Erythrocyte Flexibility

  after 12 weeks treatment

• Postprandial Erythrocyte Flexibility

  after 12 weeks treatment

• Fasting GLP-1 levels

  after 12 weeks treatment

• Postprandial GLP-1 levels

  after 12 weeks treatment

• Fasting cGMP

  after 12 weeks treatment

• Postprandial cGMP

  after 12 weeks treatment

• Fasting Calcitonin

  after 12 weeks treatment

• Fasting PAI-1 levels

  after 12 weeks treatment

• Postprandial PAI-1 levels

  after 12 weeks treatment

• Fasting ADMA levels

  after 12 weeks treatment

• Postprandial ADMA levels

  after 12 weeks treatment

• Fasting Malonyldialdehyd

  after 12 weeks treatment

• fasting oxidatively modified nucleosides 8-oxodG and 8-oxoGuo

  after 12 weeks treatment

Secondary Outcomes (2)

• Hypoglycemic events

  after 12 weeks treatment

• Body Weight

  after 12 weeks treatment

Study Arms (2)

Glimepiride-ratiopharm

ACTIVE COMPARATOR

Glimepiride (1-4mg) as add on therapy

Drug: Glimepiride

Trajenta

EXPERIMENTAL

Linagliptin 5 mg as add on therapy

Drug: Linagliptin

Interventions

Linagliptin DRUG

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

Trajenta

Glimepiride DRUG

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

Also known as: Glimepirid-ratiopharm

Glimepiride-ratiopharm

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pretreatment with PPAR gamma agonists within the last three months
• History of type 1 diabetes
• Uncontrolled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>90 mmHg)
• Acute infections
• Medical history of hypersensitivity to the study drugs or to drugs with similar chemical structures
• History of severe or multiple allergies
• Treatment with any other investigational drug within 3 months before trial entry.
• Progressive fatal disease
• History of drug or alcohol abuse in the past 2 years
• State after kidney transplantation
• Serum potassium \> 5.5 mmol/L
• Pregnancy or breast feeding
• 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.
• Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous 30 days
• Any elective surgery during study participation

Sponsors & Collaborators

• Marcus Borchert: lead
• ikfe-CRO GmbH: collaborator
• Boehringer Ingelheim: collaborator

Study Sites (1)

ikfe GmbH

Mainz, Rhineland-Palatinate, 55116, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin; glimepiride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Officials

• Thomas Forst, MD, PhD

  Ikfe GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Forst, MD, PhD

CONTACT

+ 49 6131 57636; ThomasF@ikfe.de

Claudia Forkel

CONTACT

+ 49 6131 32790; C.Forkel@ikfe-cro.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Thomas Forst

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 7, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 11, 2012

Record last verified: 2012-04

Locations

DE (1)