Phase 4
N=1,423
The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus, Non-Insulin-Dependent
Bottom Line
View on ClinicalTrials.gov: NCT01608724 ↗Enrolled (actual)
1,423
Serious AEs
1.8%
Results posted
Feb 2016
Primary outcome: Primary: Absolute Change From Baseline in Haemoglobin A1c (HbA1c) — -1.19; -1.59; -1.61 (%)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Saxagliptin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Haemoglobin A1c (HbA1c) |
-1.19; -1.59; -1.61 | — |
| SECONDARY Proportion (%) of Patients Achieving HbA1c <7% |
25.4; 45.6; 44.1 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
-0.77; -0.89; -0.74; -0.55 | — |
| SECONDARY Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG) |
-2.83 | — |
Summary
The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with type 2 diabetes mellitus.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01608724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.