24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Saxagliptin (Drug); Acarbose (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: AstraZeneca
Summary
SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active
Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin
Compared with Acarbose when in Combination with Metformin in Patients with Type 2 Diabetes
Mellitus (T2D) Inadequately Controlled with Metformin Monotherapy
Clinical Details
Official title: SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With Type 2 Diabetes Mellitus (T2D) Inadequately Controlled With Metformin Monotherapy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Efficacy of saxagliptin plus metformin on glycemic control compared with acarbose plus metformin in patients with T2D inadequately controlled with metformin. By Measure absolute change from baseline in HbA1c at Week 24
Secondary outcome: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion of patients with any gastrointestinal adverse events, proportion of patients achieving HbA1c<7.0% without GI adverse events.Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24 Effects of saxagliptin versus acarbose on the additional parameters, by measure proportion of patients achieving a therapeutic glycemic response defined as HbA1c<7.0%
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Diagnosed with type 2 diabetes mellitus
2. Men and women (non-pregnant and using a medically approved birth-control method) aged
at least 18 years at screening.
3. T2D patients treated with stable metformin monotherapy for at least 8 weeks prior to
screening. Metformin dose should be ≥ 1500 mg/day (or individual maximally tolerated
dose), but not more than the maximum dose specified in the label
4. HbA1c ≥ 7. 5% and ≤ 11. 0% at screening or within 4 weeks prior to screening (by local
laboratory) and HbA1c ≥ 7. 0% and ≤ 11. 0% at pre-randomization visit (by central
laboratory)
5. FPG ≤ 13. 3 mmol/L (≤ 240 mg/dL) at pre-randomization visit (by central laboratory)
6. Able and willing to provide written informed consent and to comply with the study
protocol
Exclusion Criteria:
1. Women who are pregnant, intending to become pregnant during the study period,
lactating females, or women of child-bearing potential not using highly effective,
medically approved birth control methods.
2. Diagnosis or history of:
1. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary
forms of diabetes, eg, acromegaly or Cushing's syndrome.
2. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma
within the past 6 months.
3. Previous treatment with any dipeptidyl peptidase-4 (DPP4) inhibitor or GLP-1
receptor agonists within the past one year.
4. History of hypersensitivity reaction (e. g., anaphylaxis, angioedema, exfoliative skin
conditions) to dipeptidyl peptidase-4 inhibitor (DPP4) or Acarbose.
5. Treatment with any anti-diabetic medication for more than 7 consecutive days other
than metformin in the last 8 weeks prior to screening
Locations and Contacts
Research Site, Shanghai, China
Additional Information
Starting date: September 2014
Last updated: June 15, 2015
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