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

Type 2 Diabetes Mellitus Clinical Trial

— SMART  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02243176
• Other study ID #: D1680L00018
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2014
• Last updated: January 11, 2016
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 689
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 150 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Saxagliptin
The dose of saxaglitpin will be 5mg oral qd.
• Acarbose
Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose.

Locations

Country	Name	City	State
China	Research Site	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and tolerability of Saxagliptin versus Acarbose by measure adverse events/serious adverse events, Vital signs, Clinical chemistry/haematology parameters.	Safety Objective	From baseline to 24 week	Yes
Other	The patient report outcomes (PROs)of Saxagliptin versus Acarbose by measure Change from baseline in EQ-5D(European Quality of Life-5 Dimensions) at week 24	Exploratory Objective	From baseline to 24 week	No
Primary	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	Primary Objective	From baseline to 24 week	No
Secondary	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.	Secondary Objective	From baseline to 24 week	Yes
Secondary	Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, ß-cell function, body weight at week 24	Secondary Objective	From baseline to 24 week	No
Secondary	Effects of saxagliptin versus acarbose on the additional parameters, by measure proportion of patients achieving a therapeutic glycemic response defined as HbA1c<7.0%	Secondary Objective	From baseline to 24 week	No