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
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy 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

Resource links provided by NLM:


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 ]

Enrollment: 2165
Study Start Date: November 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open label
Saxagliptin, oral 5mg once a day(Q. D.)
Drug: Saxagliptin
oral, 5 mg once a day (Q.D.)
Other Name: Onglyza

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
China
Research Site
Baotou, China
Research Site
Beijing, China
Research Site
Benxi, China
Research Site
Changchun, China
Research Site
Chengdu, China
Research Site
Chongqing, China
Research Site
Dalian, China
Research Site
Dongguan, China
Research Site
Foshan, China
Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Guiyang, China
Research Site
Haikou, China
Research Site
Hangzhou, China
Research Site
Hhht, China
Research Site
Hubei, China
Research Site
Jimo, China
Research Site
Jinan, China
Research Site
Kunming, China
Research Site
Linyi, China
Research Site
Nanjing, China
Research Site
Nantong, China
Research Site
Qingdao, China
Research Site
Shanghai, China
Research Site
Shantou, China
Research Site
Shenyang, China
Research Site
Shiyan, China
Research Site
Suzhou, China
Research Site
Taiyuan, China
Research Site
Tianjin, China
Research Site
Urumqi, China
Research Site
Wenzhou, China
Research Site
Wuhan, China
Research Site
Wuxi, China
Research Site
Xian, China
Research Site
Zhanjiang, China
Research Site
Zhengzhou, China
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Simon Fisher 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: June 13, 2014
Health Authority: China: Ethics Committee

Keywords provided by AstraZeneca:
Type 2 DM

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

ClinicalTrials.gov processed this record on October 22, 2014