Efficacy and Safety of Saxagliptin VS. Glimepiride in Chinese T2DM Patients Controlled Inadequately With Metformin

NCT02280486 | Completed Phase 4 DMC

• 1 other identifier: ISSSAXA0014
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-centre, open-label, randomized, parallel trial to investigate the efficacy and safety profile of saxagliptin and glimepiride treatment in patients with type 2 diabetes inadequately controlled with metformin monotherapy.

Conditions

Type 2 Diabetes

Keywords

saxagliptin; glimepiride; metformin monotherapy

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving glycemic response defined as Glycosylated hemoglobin (HbA1c) < 7.0%

  Compare the proportion of subjects after 48-week treatment achieving HbA1c\<7.0%, with no hypoglycemia and no body weight gain (defined as glucose \< 3.9 mmol/L with or without symptoms and weight gain \< 3.0%).

  Change from Baseline after 48 weeks treatment

Secondary Outcomes (4)

• The change in blood glucose fluctuations of subjects.

  Change from Baseline after 48 weeks treatment

• The improvement in beta-cell function of subjects

  Change from Baseline after 48 weeks treatment

• The change in body composition of subjects.

  Change from Baseline after 48 weeks treatment

• Safety and tolerability of saxagliptin vs. glimepiride measured by adverse events, serious adverse events (SAEs); laboratory assessments (biochemistry, lipids, blood and urine routine tests

  Change from Baseline after 48 weeks treatment

Study Arms (2)

Saxagliptin

ACTIVE COMPARATOR

The treatment of saxagliptin will be initiated and maintained at 5mg every morning until the completion of the test.Meanwhile,subjects will be instructed to take stable doses of metformin (1500mg/d) through the whole trial.

Drug: Saxagliptin; Drug: Glimepiride

Glimepiride

ACTIVE COMPARATOR

Glimepiride will be initially treated with 1 mg every morning to a dose of 6 mg/day.a.m. Every 4-week the subjects will be evaluated whether reach the target fasting plasma glucose (assayed by finger-stick ≦6.1 mmol/l ). If the fasting blood glucose not achieved the target at the maximum dose, maintain the maximum dose(6mg/d) until the completion of the test.Meanwhile,subjects will be instructed to take stable doses of metformin (1500mg/d) through the whole trial.

Drug: Saxagliptin; Drug: Glimepiride

Interventions

Saxagliptin DRUG

5 mg/d

Also known as: Onglyza，Astrazeneca

Glimepiride; Saxagliptin

Glimepiride DRUG

1mg/d, up titrated 1mg if FPG \>6.1 mmol/L (110mg/dL) till 6 mg

Also known as: Amaryl，Sanofi-Aventis

Glimepiride; Saxagliptin

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Type2 diabetic patients had been on stable, maximum tolerated doses of metformin (≧1500mg/d, ≧8 weeks)
• Male or female age ≧ 25 years and ≦75 years old
• HbA1c ≧7.0 and ≦9.5%
• BMI ≧ 20 and ≦ 30 kg/m2

You may not qualify if:

• Known or suspected allergy to trial products or related products.
• Impaired renal function defined as serum-creatinine ≥ 1.5 mg/dL (≥ 132.6 μmol/l).
• Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, shock.
• Hepatic insufficiency, acute alcohol intoxication, alcoholism.
• Subjects has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (MI), arrhythmias or conduction delays on ECG, unstable angina, or decompensated heart failure (New York Heart Association-class Ⅲ and Ⅳ).
• Proliferative retinopathy or muscular oedema requiring acute treatment.
• Lactation.
• Pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception (adequate contraceptive measures are sterilization, intrauterine device, oral contraceptives or barrier methods).
• Treatment with systemic corticosteroids within the past two months prior to screening.
• Tested positive for glutamic acid decarboxylase antibody.
• Receipt of any investigational drug within 1 month prior to this trial.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Zhongda Hospital: collaborator
• Nanjing PLA General Hospital: collaborator
• Changzhou No.2 People's Hospital: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Wuxi People's Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Huai'an First People's Hospital: collaborator

Study Sites (1)

at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 210008, China

Location

Related Publications (1)

• Gu T, Ma J, Zhang Q, Zhu L, Zhang H, Xu L, Cheng J, Shi B, Li D, Shao J, Sun Z, Zhong S, Bi Y, Zhu D. Comparative effect of saxagliptin and glimepiride with a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in patients uncontrolled with metformin therapy: Results from the SPECIFY study, a 48-week, multi-centre, randomized, controlled trial. Diabetes Obes Metab. 2019 Apr;21(4):939-948. doi: 10.1111/dom.13605. Epub 2019 Jan 4.

  PMID: 30520221 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptin; glimepiride

Condition Hierarchy (Ancestors)

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

Study Officials

• Dalong Zhu, MD, PhD

  the Affiliated Drum Tower Hospital of Nanjing University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 31, 2014
• Study Start: January 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2017
• Last Updated: July 23, 2018

Record last verified: 2018-03

Locations

CN (1)