Clinical trial NCT02243176: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Saxagliptin
Acarbose
Type 2 Diabetes
Metformin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 689
Sex: ALL
Minimum age (years): 18
Maximum age (years): 150
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Absolute Change From Baseline in HbA1c at Week 24 (DAO)
timeFrame: From baseline to 24 week
measure: Absolute Change From Baseline in HbA1c at Week 24 (DAO)
timeFrame: From baseline to 24 week
Secondary outcomes:
measure: Proportion (%) of Patients With Any GI Adverse Events
timeFrame: 24 weeks
measure: Proportion (%) of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c<7.0%
timeFrame: 24 weeks
measure: Proportion (%) of Patients Achieving HbA1c<7.0% Without GI Adverse Events
timeFrame: Whole study duration
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
timeFrame: From baseline to 24 week
measure: Change From Baseline in 2H Postprandial Glucose (2HPPG)
timeFrame: From baseline to 24 week
measure: Change From Baseline in HOMA-β
timeFrame: From baseline to 24 week
measure: Change From Baseline in Body Weight
timeFrame: From baseline to 24 week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Research Site
Study officials:
References:
citation: Du J, Liang L, Fang H, Xu F, Li W, Shen L, Wang X, Xu C, Bian F, Mu Y. Efficacy and safety of saxagliptin compared with acarbose in Chinese patients with type 2 diabetes mellitus uncontrolled on metformin monotherapy: Results of a Phase IV open-label randomized controlled study (the SMART study). Diabetes Obes Metab. 2017 Nov;19(11):1513-1520. doi: 10.1111/dom.12942. Epub 2017 Jul 6.