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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01608724
First received: May 28, 2012
Last updated: June 13, 2014
Last verified: June 2014

May 28, 2012
June 13, 2014
November 2012
May 2014   (final data collection date for primary outcome measure)
Absolute change from baseline in HbA1c [ Time Frame: baseline( visit 2); 6 weeks (visit 3); 12 weeks( visit 4); 24 weeks ( visit 6) ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01608724 on ClinicalTrials.gov Archive Site
  • Proportion of patients achieving HbA1c <7% [ Time Frame: baseline( visit 2); 6 weeks (visit 3); 12 weeks( visit 4); 24 weeks ( visit 6) ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: baseline( visit 2); 6 weeks (visit 3); 12 weeks( visit 4); 18 weeks (visit 5); 24 weeks ( visit 6) ] [ Designated as safety issue: No ]
  • Change from baseline in 2-hour postprandial plasma glucose (2h-PPG) [ Time Frame: baseline( visit 2); 24 weeks ( visit 6) ] [ Designated as safety issue: No ]
  • Change from baseline in HbA1c in sub population by age (Age<65y; Age≥65y) [ Time Frame: baseline( visit 2); 6 weeks (visit 3); 12 weeks( visit 4); 18 weeks (visit 5); 24 weeks ( visit 6) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus
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

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

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

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Non-Insulin-Dependent
Drug: Saxagliptin
oral, 5 mg once a day (Q.D.)
Other Name: Onglyza
Experimental: Open label
Saxagliptin, oral 5mg once a day(Q. D.)
Intervention: Drug: Saxagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2165
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01608724
D1680L00008
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Simon Fisher AstraZeneca
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP