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

NCT02243176 | Completed Phase 4 Results

• 1 other identifier: D1680L00018
• Study Type: interventional
• Target: 689
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Mellitus

Keywords

Saxagliptin; Acarbose; Type 2 Diabetes; Metformin

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  From baseline to 24 week

Secondary Outcomes (7)

• Proportion (%) of Patients With Any GI Adverse Events

  24 weeks

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

  24 weeks

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

  Whole study duration

• Change From Baseline in Fasting Plasma Glucose (FPG)

  From baseline to 24 week

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

  From baseline to 24 week

Study Arms (2)

Saxagliptin

EXPERIMENTAL

The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.

Drug: Saxagliptin

Acarbose

ACTIVE COMPARATOR

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. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.

Drug: Acarbose

Interventions

Saxagliptin DRUG

The dose of saxaglitpin will be 5mg oral qd.

Also known as: Onglyza

Saxagliptin

Acarbose DRUG

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.

Also known as: Glucobay

Acarbose

Eligibility Criteria

• Age: 18 Years - 150 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with type 2 diabetes mellitus
• Men and women (non-pregnant and using a medically approved birth-control method) aged at least 18 years at screening.
• 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
• 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)
• FPG ≤ 13.3 mmol/L (≤ 240 mg/dL) at pre-randomization visit (by central laboratory)
• Able and willing to provide written informed consent and to comply with the study protocol

You may not qualify if:

• 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.
• Diagnosis or history of:
• Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, eg, acromegaly or Cushing's syndrome.
• Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months.
• Previous treatment with any dipeptidyl peptidase-4 (DPP4) inhibitor or GLP-1 receptor agonists within the past one year.
• History of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to dipeptidyl peptidase-4 inhibitor (DPP4) or Acarbose.
• Treatment with any anti-diabetic medication for more than 7 consecutive days other than metformin in the last 8 weeks prior to screening

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 28296055 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptin; Acarbose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Xia, Zhang
• Organization: ASTRAZENECA INVESTMENT (CHINA) CO., LTD.

Xia.Zhang@astrazeneca.com

+86 21 6030 2288

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 17, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 14, 2017
• Results First Posted: April 14, 2017

Record last verified: 2017-03

Locations

CN (1)