NCT01751321

Brief Summary

Glucose Variability With DPP-4 Inhibition

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable type-2-diabetes

Status
unknown

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

First Submitted

Initial submission to the registry

December 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

4 months

First QC Date

December 13, 2012

Last Update Submit

December 13, 2012

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • glucose variability

    1 month

Study Arms (1)

sitagliptin, metformin, placebo

OTHER

1. group- 25 patients will take sitagliptin 50 mg and metformin 1000 mg twice in a day 2. group- 25 patients will take placebo 50 mg and metformin 1000 mg twice in a day

Drug: Sitagliptin, placebo

Interventions

Sitagliptin, placeboDRUG

sitagliptin 50 / metformin 1000 twice in a day and placebo 50 mg /metformin 1000 twice in a day

Also known as: Januvia
sitagliptin, metformin, placebo

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • receiving a stable dose of metformin ≥ 1500 mg
  • HbA1c 7,5% -10/0 %

You may not qualify if:

  • Type 1 diabetes
  • HbA1c \< 7,5% and \> 10,0%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Alexander Ametov, MD

    Research Clinical Centre of the Russian Railways, JSC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 17, 2012

Study Start

May 1, 2013

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

December 17, 2012

Record last verified: 2012-12