NCT01193296

Brief Summary

The study will assess glycemic variability and optimized glycemic control in T2DM patients treated with a DPP-4 inhibitor as add-on therapy to metformin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

7 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

June 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 4, 2012

Status Verified

May 1, 2012

Enrollment Period

1 year

First QC Date

August 31, 2010

Last Update Submit

May 3, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes mellitus, vildagliptin, continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

  • Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion)

    8 weeks

Secondary Outcomes (3)

  • Glycemic control assessed through CSGM

    8 weeks

  • Glycemic control assessed by A1C, FPG, PPG and the mean of 6 points self-monitoring of blood glucose (SMBG) at baseline and after 8 weeks

    8 weeks

  • Unrecognized hypoglycemic periods recorded by CSGM, frequency and duration

    8 weeks

Study Arms (2)

Vildagliptin

EXPERIMENTAL
Drug: Vildagliptin

Sitagliptin

ACTIVE COMPARATOR
Drug: Sitagliptin

Interventions

VildagliptinDRUG
Vildagliptin
SitagliptinDRUG
Sitagliptin

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes Mellitus (DM) willing to perform SMBG at least 6 times daily to use the MiniMed CGMS for up to 3 consecutive days on 2 occasions.
  • HbA1c: 6.5 to 9% with metformin monotherapy for a least 3 months

You may not qualify if:

  • Age \>= 80 years
  • BMI \<= 22 and \>=40 kg/m2
  • Secondary T2 DM
  • Hepatic failure, ASAT/ALAT\>3 ULN, and moderate/severe renal failure (CI \< 50 ml/min) CHF III \& IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Investigative Site

Bondy, France

Location

Investigative Site

Corbeil, France

Location

Investigative Site

Marseille, France

Location

Investigative Site

Nancy, France

Location

Investigative Site

Paris, France

Location

Investigative Site

Toulouse, France

Location

Investigative Site

Vénissieux, France

Location

Related Publications (2)

  • Guerci B, Monnier L, Serusclat P, Petit C, Valensi P, Huet D, Raccah D, Colette C, Quere S, Dejager S. Continuous glucose profiles with vildagliptin versus sitagliptin in add-on to metformin: results from the randomized Optima study. Diabetes Metab. 2012 Oct;38(4):359-66. doi: 10.1016/j.diabet.2012.06.001. Epub 2012 Jul 17.

    PMID: 22809630DERIVED

  • Monnier L, Colette C, Comenducci A, Vallee D, Dejager S. Add-on therapies to metformin in type 2 diabetes: what modulates the respective decrements in postprandial and basal glucose? Diabetes Technol Ther. 2012 Oct;14(10):943-50. doi: 10.1089/dia.2012.0045. Epub 2012 Jul 9.

    PMID: 22775317DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

VildagliptinSitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTriazolesAzolesPyrazines

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

August 31, 2010

First Posted

September 1, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 4, 2012

Record last verified: 2012-05

Locations

FR(7)