A Phase IV Study in Drug-Naive Patients With T2DM in China

NCT03344341 | Terminated Phase 4

• 1 other identifier: D1690C00060
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 20

Brief Summary

This is a 24-week, multicenter, randomized, open-label, parallel-group, active controlled Phase IV study to assess the efficacy and safety of Dapagliflozin as monotherapy compared with Acarbose in patients with T2DM who were inadequately controlled with diet and exercise. The study is designed to evaluate the efficacy and safety of dapagliflozin monotherapy compared with acarbose monotherapy in patients with T2DM inadequately controlled with diet and exercise.

Conditions

Type 2 Diabetes Mellitus

Keywords

T2DM

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in HbA1c at Week 24

  Which will be derived using the HbA1c (%) at week 24 minus HbA1c (%) at baseline.

  At week 24

Secondary Outcomes (9)

• Percentage of patients at Week 24 with reduction of HbA1c≥0.5%, body weight≥3% and SBP ≥3mmHg from baseline

  From baseline to week 24

• Percentage of patients achieving HbA1c<7.0%

  From baseline to week 24

• Percentage of patients with reduction of HbA1c≥0.5%

  From baseline to week 24

• Absolute change from baseline in fasting plasma glucose (FPG)

  From baseline to week 24

• Absolute change from baseline in 2h postprandial glucose (PPG)

  From baseline to week 24

Other Outcomes (3)

• Homeostasis model assessment-β

  From baseline to week 24

• HOMA-IR

  From baseline to week 24

• The difference of the number between tablets taken and tablets prescribed

  From baseline to week 24

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin is started from 5 mg once a day, taken orally in the morning, before or after breakfast. From the third week, the dose will be increased to 10 mg once a day and last to the end of the study.

Drug: Dapagliflozin

Acarbose

ACTIVE COMPARATOR

Acarbose is started from 50 mg once a day at dinner during the first week, titrated up to 50 mg twice a day at lunch and dinner in the second week, 50 mg three times a day at three meals in the third week, and 100 mg three times a day till the end of the study.

Drug: Acarbose

Interventions

Dapagliflozin DRUG

Starting dose of dapagliflozin is 5 mg once daily, taken orally in the morning, before or after breakfast. From the third week,the dose can be increased to 10 mg once daily, and last to the end of the study.

Dapagliflozin

Acarbose DRUG

Acarbose was started from 50 mg once a day at dinner during the first week and titrated up to 50 mg twice a day at lunch and dinner in the second week, 50 mg three times a day at three meals in the third week, and 100 mg three times a day till the end of the study.

Acarbose

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed within the past 12 months with T2DM according to 1999 World Health Organization(WHO) criteria.
• Men and women aged at least 18 years at screening.
• Either not received oral anti-diabetic drugs or had been on short-term (1 month) treatment that had been discontinued 3 months before enrolment.
• HbA1c ≥ 7.5% and ≤ 10.5% at screening and HbA1c ≥ 7.0% and ≤ 10.5% at pre-randomization visit.
• FPG ≤ 13.3 mmol/L (≤ 240 mg/dL) .
• BMI≥18.5 kg/m2 and ≤ 45.0 kg/m2 .
• C-peptide ≥0.33nmol/L(≥1.0 ng/mL).
• Able and willing to provide written informed consent and to comply with the study.

You may not qualify if:

• Women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods.
• Diagnosis or history of:
• a. Acute metabolic diabetic complications such as ketoacidosis or hyperglycemic hyperosmolar state b. Diabetes insipidus.
• Requirement for insulin therapy. Symptoms of poorly controlled diabetes, including but not limited to, marked polyuria and polydipsia with \>10% weight loss during the 3 months before enrollment.
• Triglycerides (fasting) \> 9.3 mmol/L (\> 800 mg/dL).
• Patients with clinically apparent hepatobiliary disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency. Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) \> 3x upper limit of normal (ULN), or serum total bilirubin (TB) \>34.2 μmol/L (\>2 mg/dL).
• Patients with following renal disease history or renal disease related features:
• History of unstable or rapidly progressing renal disease;
• Patients with moderate /severe renal impairment or end-stage renal disease (eGFR\< 60 mL/min/1.73 m2);
• Urinary albumin: creatinine ratio \>1800 mg/g;
• Serum creatinine (Cr) ≥133 μmol/L (≥1.50 mg/dL) for male subjects; Serum Cr≥124 μmol/L (≥1.40 mg/dL) for female subjects;
• Conditions of congenital renal glycosuria.
• Severe uncontrolled hypertension defined as SBP ≥180 mmHg and/or BP ≥110 mmHg; Patients with SBP \< 95mmHg.
• Any of the following cardiovascular diseases within 6 months of the enrollment visit:
• Myocardial infarction;

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (20)

Research Site

Beijing, 100020, China

Location

Research Site

Beijing, 100730, China

Location

Research Site

Changsha, 410013, China

Location

Research Site

Chengdu, 610041, China

Location

Research Site

Chongqing, 400016, China

Location

Research Site

Guangzhou, 510280, China

Location

Research Site

Hangzhou, 310014, China

Location

Research Site

Hangzhou, 310016, China

Location

Research Site

Hefei, 230022, China

Location

Research Site

Jinan, 250012, China

Location

Research Site

Nanjing, 2100008, China

Location

Research Site

Qingdao, 266003, China

Location

Research Site

Qingdao, China

Location

Research Site

Shanghai, 200233, China

Location

Research Site

Shanghai, CN-200120, China

Location

Research Site

Shenyang, 100003, China

Location

Research Site

Suzhou, 215004, China

Location

Research Site

Tianjin, CN-300070, China

Location

Research Site

Xi'an, 710061, China

Location

Research Site

Yinchuan, 750004, China

Location

Related Publications (1)

• 1. Cefalu, W.T., et al., Dapagliflozin's Effects on Glycemia and Cardiovascular Risk Factors in High-Risk Patients With Type 2 Diabetes: A 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a 28-Week Extension. Diabetes Care, 2015. 38(7): p. 1218-27. 2. Yang, W., et al., Prevalence of diabetes among men and women in China. N Engl J Med, 2010. 362(12): p. 1090-101. 3. Ji, L., et al., Primacy of the 3B approach to control risk factors for cardiovascular disease in type 2 diabetes patients. Am J Med, 2013. 126(10): p. 925.e11-22. 4. 中华医学会糖尿病学分会, 中国2型糖尿病防治指南(2013年版). 中华糖尿病杂志, 2014. 06((07): p. 447-498. 5. Komoroski, B., et al., Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther, 2009. 85(5): p. 513-9. 6. Henry, R.R., et al., Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract, 2012. 66(5): p. 446-56. 7. Nauck, M.A., et al., Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care, 2011. 34(9): p. 2015-22. 8. 中华医学会糖尿病分会, 中国2型糖尿病防治指南2013年版. 9. Johnsson, K.M., et al., Urinary tract infections in patients with diabetes treated with dapagliflozin. J Diabetes Complications, 2013. 27(5): p. 473-8. 10. Johnsson, K.M., et al., Vulvovaginitis and balanitis in patients with diabetes treated with dapagliflozin. J Diabetes Complications, 2013. 27(5): p. 479-84.

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; 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

Study Officials

• Weiping Jia

  Shanghai 6th People's Hospital

  STUDY CHAIR

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: November 13, 2017
• First Posted: November 17, 2017
• Study Start: December 15, 2017
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: December 7, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (20)