NCT03125694

Brief Summary

This study has been designed to investigate the comparative effects of sitagliptin vs. pioglitazone as add-on treatments in patients with type 2 diabetes who were uncontrolled on the full-dose of metformin and sulfonylurea

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

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

February 1, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2017

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

2.2 years

First QC Date

March 22, 2017

Last Update Submit

April 19, 2017

Conditions

Uncontrolled Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in mean glycated hemoglobin (A1C) levels by sitagliptin vs. pioglitazone

    52 weeks

Study Arms (2)

Sitagliptin

ACTIVE COMPARATOR
Drug: Sitagliptin 100mg

Pioglitazone

ACTIVE COMPARATOR
Drug: Pioglitazone 30 mg

Interventions

Sitagliptin 100mgDRUG

Sitagliptin arm took sitagliptin 100 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks

Sitagliptin
Pioglitazone 30 mgDRUG

Pioglitazone arm took pioglitazone 30 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks

Pioglitazone

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of type 2 diabetes according to the American Diabetes Association
  • Baseline level of 7% ≤ A1C \< 11% despite a minimum 6 months period of active treatment with metformin 2000 mg/day plus gliclazide 240 mg/day (uncontrolled type 2 diabetes)

You may not qualify if:

  • Acute or chronic diseases of heart, lung, kidney,
  • Active or past infectious conditions
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Iran

Location

MeSH Terms

Interventions

Sitagliptin PhosphatePioglitazone

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesThiazolidinedionesThiazolesSulfur CompoundsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor of Medicine

Study Record Dates

First Submitted

March 22, 2017

First Posted

April 24, 2017

Study Start

February 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 24, 2017

Record last verified: 2017-04

Locations

IR(1)