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

AstraZeneca689 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

689

Conditions

Type 2 Diabetes Mellitus

Interventions

SaxagliptinDRUG

The dose of saxaglitpin will be 5mg oral qd.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 150 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Absolute Change From Baseline in HbA1c at Week 24 (DAO)

Primary Objective: 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

Time frame: From baseline to 24 week

Absolute Change From Baseline in HbA1c at Week 24 (DAO)

The primary endpoint was analyzed based on Per protocol analysis set as the supportive analysis.

Time frame: From baseline to 24 week

Secondary Outcomes

Proportion (%) of Patients With Any GI Adverse Events

Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients with any gastrointestinal adverse events.

Time frame: 24 weeks

Proportion (%) of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c<7.0%

Secondary Objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure proportion (%) of patients achieving a therapeutic glycemic response defined as HbA1c\<7.0%

Time frame: 24 weeks

Proportion (%) of Patients Achieving HbA1c<7.0% Without GI Adverse Events

Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients achieving HbA1c\<7.0% without GI adverse events.

Time frame: Whole study duration

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame: From baseline to 24 week

Change From Baseline in 2H Postprandial Glucose (2HPPG)

Time frame: From baseline to 24 week

Change From Baseline in HOMA-β

Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function was estimated by the Homeostasis model assessment-β (HOMA-β), which was defined as fasting insulin (mU/mL) x 20 / (fasting glucose (mmol/mL) - 3.5, body weight at week 24

Time frame: From baseline to 24 week

Change From Baseline in Body Weight

Time frame: From baseline to 24 week

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes