Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea

Uncontrolled Type 2 Diabetes Mellitus Clinical Trial

Official title:

Efficacy, Durability, Safety, and Tolerability of Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea: a 52-week, Randomized, Open-label, Parallel-group, Phase 3 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125694
• Other study ID #: 9311160040
• Status: Completed
• Phase: Phase 3
• First received: March 22, 2017
• Last updated: April 19, 2017
• Start date: February 1, 2015
• Est. completion date: April 1, 2017

Study information

• Verified date: April 2017
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Acute or chronic diseases of heart, lung, kidney,

• Active or past infectious conditions

• Malignancy

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Uncontrolled Type 2 Diabetes Mellitus

Intervention

Drug:
• Sitagliptin 100mg
Sitagliptin arm took sitagliptin 100 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks
• Pioglitazone 30 mg
Pioglitazone arm took pioglitazone 30 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean glycated hemoglobin (A1C) levels by sitagliptin vs. pioglitazone		52 weeks