Study to Understand Usage and Effect of Saxagliptin as First Add-On After Metformin in Indian Type 2 Diabetes Mellitus Patients

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT02588859
• Lead Sponsor: AstraZeneca

Brief Summary

This is a multicentre, non-interventional, prospective, observational study which would be conducted in India to understand the usage and effect of saxagliptin as first add-on therapy after metformin. The study will enroll Type 2 Diabetes Mellitus (T2DM) patients who were inadequately controlled with metformin alone and have been recently prescribed saxagliptin as an add-on to metformin.

Detailed Description

This is a multicentre, non-interventional, prospective, observational study which would be conducted in India to understand the usage and effect of saxagliptin as first add-on therapy after metformin. The study will enroll Type 2 Diabetes Mellitus (T2DM) patients who were inadequately controlled with metformin alone and have been recently (i.e. within past 15 days) prescribed saxagliptin as an add-on to metformin.

The Investigator/designee would get signed informed consent from potential subjects of the study. The patients who meet all inclusion and none of the exclusion criteria will be enrolled in the study. These patients will then be assigned a patient identification number for the study. The Investigator/designee will collect the information as per the study schedule. This will be considered as Visit 1 of the patients. The patients will be managed as per the routine clinical practice of the physician for their condition and this study will neither interfere/advise the Investigators/designee for any drug/medication to be prescribed to the patients nor prescribe any intervention to them.The enrolled patients would then be asked to visit their respective study sites after 3 months ( +7 days) for the Visit-2 of study.

Around 50 study centers throughout India will be selected with a goal of enrolling up to 1500 patients (approximately 30 subjects each per site). The study will be initiated after obtaining written approval of Independent/Institutional Ethics Committee and written Informed consent of the patient.

Study Timeline

• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Study Start: 2015-10-30
• Primary Completion: 2016-12-26
• Study Completion: 2016-12-26
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Patients willing to provide informed consent.
2. Female or male patients aged 18 years or above.
3. Patients with known case of Type 2 diabetes mellitus.
4. Patients with inadequate glycaemic control taking metformin monotherapy (minimum dose of 500 mg OD) for at least 3 months.
5. Patients who have recently (last 15 days) been prescribed saxagliptin in addition to metformin.

Exclusion Criteria

1. Patients with Type 1 diabetes mellitus.
2. Patients taking glucose lowering drugs apart from metformin or saxagliptin.
3. Any medical condition of the patient which in the opinion of Investigator would interfere with safe completion of the study.
4. Pregnant or lactating women.
5. Women of childbearing potential not ready to use an effective barrier contraceptive method during the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Medication usage in enrolled subjects	at 3 months	By Frequency of subjects taking different doses of saxagliptin and metformin

Secondary Outcome Measures

Name	Time	Method
Reduction in HbA1C	baseline and at 3 months	Compare the reduction in HbA1C levels from baseline to follow up visit with baseline HbA1C levels

Trial Locations

Locations (1)

Research Site; 🇮🇳 new Delhi, India