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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Uncontrolled Type 2 Diabetes Mellitus

Treatments: Drug: Pioglitazone 30 mg; Drug: Sitagliptin 100mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03125694

9311160040

Details and patient eligibility

About

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

Enrollment: 250 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Sitagliptin

Active Comparator group

Treatment:

Drug: Sitagliptin 100mg

Pioglitazone

Active Comparator group

Treatment:

Drug: Pioglitazone 30 mg