The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with type 2 diabetes mellitus.

Detailed Description
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A multicenter, single arm, cohort study to evaluate the Efficacy and Safety of saxagliptin 5mg, once daily for 24 weeks, in patients with type 2 diabetes mellitus who are treatment naive or who have inadequate glycaemic control on metformin alone

Official Title
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A Multicenter, Single Arm, Cohort Study to Evaluate the Efficacy and Safety of Saxagliptin 5mg, Once Daily for 24 Weeks, in Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
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* Drug: Saxagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study specific procedures Diagnosed with type 2 diabetes Men or women who are >18 years of age at time of consenting upon Visit 1 HbA1c >7.5% and ≤11.0% Patients should be drug naive or treated with metformin alone on stable doses of for at least continues 8 weeks prior to Visit 1 Drug naive patients are defined as patients who have not received medical treatment for diabetes (insulin and/or oral hypo) Exclusion Criteria: Pregnant or breastfeeding patients Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes) Previous treatment with any DPP-IV inhibitors or GLP-1 analogue History of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to Visit 1(12 weeks for previous TZD) Treatment with systemic glucocorticoids other than replacement therapy Inhaled, local injected and topical use of glucocorticoids is allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open label<br>Saxagliptin, oral 5mg once a day(Q. D.) | Drug: Saxagliptin<br>* oral, 5 mg once a day (Q.D.)<br>* Other names: Onglyza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change From Baseline in Haemoglobin A1c (HbA1c) | Evaluation after 24 weeks oral administration of saxagliptin treatment in patients with type 2 diabetes inadequately controlled with diet and exercise or with metformin in addition to diet and exercise. | Weeks 6, 12, and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion (%) of Patients Achieving HbA1c <7% |  | Weeks 6, 12, and 24 | 
| Change From Baseline in Fasting Plasma Glucose (FPG) |  | Weeks 6, 12, 18, and 24 | 
| Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG) |  | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 DM