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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01608724
Recruitment Status : Completed
First Posted : May 31, 2012
Results First Posted : February 2, 2016
Last Update Posted : February 2, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Non-Insulin-Dependent Drug: Saxagliptin Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 2165 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Saxagliptin

Arm Intervention/treatment
Experimental: Open label
Saxagliptin, oral 5mg once a day(Q. D.)
Drug: Saxagliptin
oral, 5 mg once a day (Q.D.)
Other Name: Onglyza

Primary Outcome Measures :
  1. Absolute Change From Baseline in Haemoglobin A1c (HbA1c) [ Time Frame: 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 :
  1. Proportion (%) of Patients Achieving HbA1c <7% [ Time Frame: Weeks 6, 12, and 24 ]
  2. Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Weeks 6, 12, 18, and 24 ]
  3. Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG) [ Time Frame: Week 24 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01608724

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

Responsible Party: AstraZeneca Identifier: NCT01608724     History of Changes
Other Study ID Numbers: D1680L00008
First Posted: May 31, 2012    Key Record Dates
Results First Posted: February 2, 2016
Last Update Posted: February 2, 2016
Last Verified: December 2015

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
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents