NCT01238978

Brief Summary

The study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated with a DPP-4 inhibitor or another OAD 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
46

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2010

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

Geographic Reach
1 country

15 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, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

November 9, 2010

Last Update Submit

February 21, 2017

Conditions

Type 2 Diabetes MellitusElderly

Keywords

Diabetes mellitus, vildagliptin, hypoglycemia, elderly

Outcome Measures

Primary Outcomes (1)

  • Percent of patients in each of the two treatment groups presenting no hypoglycemia (confirmed events with SMBG and severe episodes) after 24 wk of randomized therapy added to their ongoing metformin background therapy.

    24 weeks

Secondary Outcomes (3)

  • Percent of patients reaching their therapeutic goal

    24 weeks

  • Percent of patients with success of primary EP (no confirmed/severe hypoglycemia) and reaching their therapeutic goal

    24 weeks

  • Glycemic control assessed by A1C, and the mean of 6 Points self-monitoring of blood glucose (SMBG) at baseline and after 24 weeks.

    24 weeks

Study Arms (2)

Vildagliptin

EXPERIMENTAL
Drug: Vildagliptin

other Oral Antidiabetic Drug in a different therapeutic class

ACTIVE COMPARATOR
Drug: "Usual Care"

Interventions

VildagliptinDRUG
Vildagliptin
"Usual Care"DRUG
other Oral Antidiabetic Drug in a different therapeutic class

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Type 2 Diabetes Mellitus (DM) patients aged 65 to 80 years, willing to perform SMBG in case of symptomatic hypoglycemia.
  • HbA1c: 6.5 to 8.5 % with max tolerated dose of metformin monotherapy for at least 3 months.

You may not qualify if:

  • Age \> 80 yrs
  • BMI \< 22 and ≥ 45 kg/m2
  • Secondary T2 DM
  • Hepatic failure, moderate/severe renal failure (Cl \< 50 ml/min) and CHF III \& IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Novartis Investigative Site

Armentières, 59208, France

Location

Novartis Investigative Site

Brest, 29200, France

Location

Novartis Investigative Site

Caen, 14000, France

Location

Novartis Investigative Site

Creil, 60100, France

Location

Novartis Investigative Site #2

Paris, 75012, France

Location

Novartis Investigative Site

Paris, 75020, France

Location

Novartis Investigative Site

Pau, 64000, France

Location

Novartis Investigative Site

Saint-Jean-de-la-Ruelle, 45140, France

Location

Novartis Investigative Site

Strasbourg, 67000, France

Location

Novartis Investigative Site

Strasbourg, France

Location

Novartis Investigative Site

Toulouse, 31200, France

Location

Novartis Investigative Site

Tours, 37000, France

Location

Novartis Investigative Site

Versailles, 78000, France

Location

Novartis Investigative Site

Vénissieux, 69200, France

Location

Novartis Investigative Site #2

Vénissieux, France

Location

Related Publications (1)

  • Penfornis A, Bourdel-Marchasson I, Quere S, Dejager S. Real-life comparison of DPP4-inhibitors with conventional oral antidiabetics as add-on therapy to metformin in elderly patients with type 2 diabetes: the HYPOCRAS study. Diabetes Metab. 2012 Dec;38(6):550-7. doi: 10.1016/j.diabet.2012.08.003. Epub 2012 Sep 18.

    PMID: 22996038RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusHypoglycemia

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Glucose 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 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2010

First Posted

November 11, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

FR(15)