NCT00396071

Brief Summary

This mechanistic study will evaluate the effect of vildagliptin on glucose-stimulated insulin secretion to improve the incretin effect in patients with type 2 diabetes.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

November 2, 2006

Last Update Submit

November 16, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetesvildagliptinincretin effectmetformin

Outcome Measures

Primary Outcomes (1)

  • Change in C-peptide IAUC (0-4hr)

    2 weeks after treatment

Secondary Outcomes (5)

  • Change in insulin secretion rate (ISR) relative to glucose (0-2hr)

    after 2 weeks of treatment

  • Change in postprandial C-peptide

    after two weeks of treatment

  • Change in postprandial insulin

    after two weeks of treatment

  • Change in postprandial glucagon

    after two weeks of treatment

  • Change in postprandial GLP-1

    after 2 weeks of treatment

Study Arms (2)

1

EXPERIMENTAL

Vildagliptin 100 mg qd

Drug: vildagliptin

2

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

vildagliptinDRUG

vildagliptin 100 mg

Also known as: Galvus
1
PlaceboDRUG

matching placebo

2

Eligibility Criteria

Age30 Years - 78 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes on metformin for at least 3 months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks
  • Agreement to maintain the same dose of metformin throughout the study
  • Body mass index (BMI) in the range of 22-35 kg/m2
  • HbA1c in the range of 7.0 to 9.0%
  • FPG \<200 mg/dl (11.1 mmol/L)
  • Agreement to maintain prior diet and exercise habits during the full course of the study
  • Ability to comply with all study requirements and signed informed consent to participate in the study

You may not qualify if:

  • A history of type 1 diabetes
  • A history of acute metabolic diabetic complications
  • Evidence of significant diabetic complications
  • Insulin treatment for longer than 10 days within the past 6 months
  • Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Diabetes Zentrum Bad Lauterberg

Bad Lauterberg im Harz, 37431, Germany

Location

Novartis Pharmaceuticals

Basel, Switzerland

Location

Related Publications (1)

  • Vardarli I, Nauck MA, Kothe LD, Deacon CF, Holst JJ, Schweizer A, Foley JE. Inhibition of DPP-4 with vildagliptin improved insulin secretion in response to oral as well as "isoglycemic" intravenous glucose without numerically changing the incretin effect in patients with type 2 diabetes. J Clin Endocrinol Metab. 2011 Apr;96(4):945-54. doi: 10.1210/jc.2010-2178. Epub 2011 Jan 14.

    PMID: 21239518RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 2006

First Posted

November 6, 2006

Study Start

October 1, 2006

Primary Completion

November 1, 2007

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

CH(1)DE(1)