NCT01565096

Brief Summary

The aim of this pilot-study is to investigate the effect of Vildagliptin in comparison to glimepiride on beta cell function and the cardiovascular risk profile in patients previously treated with Metformin monotherapy.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Last Updated

March 28, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

March 23, 2012

Last Update Submit

March 26, 2012

Conditions

Diabetes Mellitus Type II

Outcome Measures

Primary Outcomes (1)

  • Postprandial increase in intact proinsulin levels in patient treated with Vildagliptin and Metformin compared to intact proinsulin levels in patients treated with Glimepiride and Metformin (Area under the curve 0-300 min)

    One year

Secondary Outcomes (13)

  • Fasting intact proinsulin levels

    One year

  • Max postprandial intact proinsulin levels

    One year

  • Retinal endothelial response to flicker light stimulation

    One year

  • Mean 24h systolic and diastolic blood pressure

    One year

  • Erythrocyte deformability

    One year

  • +8 more secondary outcomes

Study Arms (2)

Vildagliptin plus Metformin

EXPERIMENTAL

Metformin (1000 mg BID) + Vildagliptin 50 mg twice daily

Drug: MetforminDrug: Vildagliptin

Glimepirid plus Metformin

ACTIVE COMPARATOR

Metformin (1000 mg BID) + Glimepiride (individual dosage)

Drug: MetforminDrug: Glimepiride

Interventions

MetforminDRUG

Metformin 1000 mg BID

Vildagliptin plus Metformin
VildagliptinDRUG

Vildagliptin 50 mg twice daily

Vildagliptin plus Metformin
GlimepirideDRUG

Glimepiride at individual dose

Glimepirid plus Metformin

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus type 2
  • HbA1c \> 6.5%\* ≤ 9.5%
  • \* NOTE: Patients with cardiovascular preconditions (Coronary Heart Disease or Myocard Infarction) require an HbA1c \> 7.0% ≤ 9.5%
  • Treatment with Metformin at maximal or maximal tolerated dosage, stable for at least 3 months with indication for treatment with an additional medication as judged by the investigator
  • Age 30 - 80 years
  • Patient consents that his/her family physician will be informed of trial participation

You may not qualify if:

  • Pre-treatment with insulin, peroxisome proliferator activated receptor (PPAR) gamma agonists or other oral antidiabetic treatments (except Metformin) within the last three months
  • History of type-1-diabetes
  • Fasting blood glucose \>240mg/dl
  • Uncontrolled hypertension (systolic blood pressure \>160 and/or diastolic blood pressure \>90)
  • Anamnestic history of acute infections
  • Anamnestic history of epilepsy
  • Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
  • History of severe or multiple allergies
  • Hereditary galactose intolerance, lapp-lactase defect or glucose-galactose mal-absorption
  • Treatment with any other investigational drug within 3 months before trial entry
  • Pregnant or lactating women
  • 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 intrauterine devices, sexual abstinence or vasectomized partner
  • Progressive fatal disease
  • History of drug or alcohol abuse in the past 2 years
  • State after kidney transplantation
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ikfe GmbH

Mainz, 55116, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

MetforminVildagliptinglimepiride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsNitrilesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Thomas Forst, Prof. Dr.

    Ikfe GmbH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Forst, Prof. Dr.

CONTACT

+49 6131 576 36 16thomasf@ikfe.de

Swantje Anders

CONTACT

+49 6131 327 90 22s.anders@ikfe-cro.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2012

First Posted

March 28, 2012

Study Start

November 1, 2011

Primary Completion

November 1, 2012

Last Updated

March 28, 2012

Record last verified: 2012-03

Locations

DE(1)