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

This study is currently recruiting participants.
Verified March 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01608724
First received: May 28, 2012
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
 Drug: Saxagliptin
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Saxagliptin
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1708
Study Start Date: November 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open label Drug: Saxagliptin
oral, 5 mg once a day (Q.D.)

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608724

Contacts
Contact: AZ Clinical Study Information +86 (0) 21 60301232 Belinda.Wang@astrazeneca.com

  Show 35 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01608724     History of Changes
Other Study ID Numbers: D1680L00008
Study First Received: May 28, 2012
Last Updated: March 20, 2013
Health Authority: China: Ethics Committee

Keywords provided by AstraZeneca:
Type 2 DM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013