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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent
• Interventions: Drug: Saxagliptin

• Registration Number: NCT01608724
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-05-28
• Study First Submitted QC: 2012-05-30
• Study First Posted: 2012-05-31
• Study Start: 2012-11
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2015-05-14
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-31
• Last Update Submitted: 2015-12-31
• Results First Posted: 2016-02-02
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open label	Saxagliptin	Saxagliptin, oral 5mg once a day(Q. D.)

Primary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Haemoglobin A1c (HbA1c)	Weeks 6, 12, and 24	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhengzhou, China