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“Effects of Vildagliptin on Beta-cell Dynamics”

“Novel Approach to Detect the Detailed Effects of Vildagliptin on Beta-cell Dynamics in Patients with Early-onset Type 2 Diabetes” - “Effects of Vildagliptin on Beta-cell Dynamics”

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-002230-37-NL
Enrollment
Unknown
Registered
2013-12-19
Start date
2013-12-19
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

impaired fasting glucose/impaired glucose tolerance, prediabetes

Interventions

Trade Name: Galvus Product Name: Vildagliptin Pharmaceutical Form: INN or Proposed INN: VILDAGLIPTIN CAS Number: 274901-16-5 Concentration unit: mg milligram(s) Concentration type: equal Pharmaceutic

Sponsors

Erasmus Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - South Asian individuals - all adult; age = 18 years - impaired fasting glucose and/or impaired glucose tolerance, which will be confirmed with a 2 hour OGTT (based on criteria of WHO) - Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -History of macrovascular disease - Heart failure - Pregnancy - Thyroid disease - COPD - Infection with/without usage of antibiotics/antiviral medication - Usage of corticosteroids

Design outcomes

Primary

MeasureTime frame
Main Objective: 3 months’ effect of vildagliptin: on beta-cell granule and synthesis insulin capacity ;Secondary Objective: - 3 months’ effect of vildagliptin on immunoassay based measurement of glucose, insulin, C-peptide levels and related OGTT indexes - 3 months-effect of vildagliptin on hormonal axes, most importantly GLP1 and GIP and Glucagon - 3 months-effect of vildagliptin on body weight, body mass index, waist-to-hip ratio, RR, plasma lipids. ;Primary end point(s): effect of vildagliptin: on beta-cell granule and synthesis insulin capacity ;Timepoint(s) of evaluation of this end point: after three months—

Secondary

MeasureTime frame
Secondary end point(s): - effect of vildagliptin on immunoassay based measurement of glucose, insulin, C-peptide levels and related OGTT indexes - effect of vildagliptin on hormonal axes, most importantly GLP1 and GIP and Glucagon - effect of vildagliptin on body weight, body mass index, waist-to-hip ratio, RR, plasma lipids. ;Timepoint(s) of evaluation of this end point: after three months—

Countries

Netherlands

Contacts

Public ContactF.W.M. de Rooij

Erasmus Medical Center

f.derooij@erasmusmc.nl+31107035457

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026