|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT01608724 |
|
Date of registration:
|
28/05/2012 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus
SUNSHINE |
|
Scientific 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 |
|
Date of first enrolment:
|
November 2012 |
|
Target sample size:
|
2165 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01608724 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Simon Fisher |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
AstraZeneca |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Diabetes Mellitus, Non-Insulin-Dependent
|
|
Intervention(s)
|
|
Drug: Saxagliptin
|
|
Primary Outcome(s)
|
|
Absolute Change From Baseline in Haemoglobin A1c (HbA1c)
[Time Frame: Weeks 6, 12, and 24]
|
|
Secondary Outcome(s)
|
|
Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG)
[Time Frame: Week 24]
|
|
Proportion (%) of Patients Achieving HbA1c <7%
[Time Frame: Weeks 6, 12, and 24]
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
[Time Frame: Weeks 6, 12, 18, and 24]
|
|
Secondary ID(s)
|
|
D1680L00008
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|