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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Saxagliptin
Glimepiride
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring saxagliptin, glimepiride, metformin monotherapy

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • For inclusion in the study subjects should fulfill the following criteria:
  • 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

Exclusion Criteria:

  • Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
  • 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Saxagliptin

Glimepiride

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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%).

Secondary Outcome Measures

The change in blood glucose fluctuations of subjects.
30 subjects of each group would be randomly chosen to evaluate blood glucose fluctuations by continuous glucose monitoring system (CGMS) before and after 48 weeks treatment.
The improvement in beta-cell function of subjects
All subjects would be tested in fasting proinsulin, proinsulin/insulin ratio, true insulin and C-peptide during standard meal test (75-gram instant noodles) before and after 48 weeks treatment.
The change in body composition of subjects.
All subjects would be measured by their weight (WT), body mass index (BMI) and waist-hip ratio (WHR) every four weeks until the end of 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
The proportion of AEs and SAEs would be measured.Incidence of hypoglycemia episodes (defined as symptoms with glucose < 3.1 mmol/L);adverse events (AEs);serious adverse events (SAEs);laboratory assessments (biochemistry, lipids, blood and urine routine tests);other safety and tolerability parameters (ECG, vital signs, physical examination).

Full Information

First Posted
October 23, 2014
Last Updated
July 19, 2018
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
The First Affiliated Hospital with Nanjing Medical University, Zhongda Hospital, Nanjing PLA General Hospital, Changzhou No.2 People's Hospital, The First Affiliated Hospital of Soochow University, Wuxi People's Hospital, The First Affiliated Hospital of Anhui Medical University, Huai'an First People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02280486
Brief Title
Efficacy and Safety of Saxagliptin VS. Glimepiride in Chinese T2DM Patients Controlled Inadequately With Metformin
Acronym
SPECIFY
Official Title
Efficacy and Safety of Saxagliptin and Glimepiride in Chinese Patients With Type 2 Diabetes Controlled Inadequately With Metformin Monotherapy (SPECIFY Study) : a 48-week, Multi-center, Randomized, Open-label Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
The First Affiliated Hospital with Nanjing Medical University, Zhongda Hospital, Nanjing PLA General Hospital, Changzhou No.2 People's Hospital, The First Affiliated Hospital of Soochow University, Wuxi People's Hospital, The First Affiliated Hospital of Anhui Medical University, Huai'an First People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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. Screening will be made to select eligible participants before intervention. The trial will include 1-week run-in period of stable doses of metformin (1500mg) and 48-week treatment period. After the run-in period, patients were randomly assigned to one of two groups for antihyperglycaemic therapies for a total of 48-weeks: saxagliptin and glimepiride. The treatment of saxagliptin will be initiated and maintained at 5mg every morning until the completion of the study. Glimepiride will be initially treated with 1 mg every morning, and further titrated up at 4-week intervals until to reach the target fasting blood glucose (FPG).As to Glimepiride groups, if the fasting blood glucose dose not achieved the target after the maximal doses, maintain the maximal doses(6mg per day) until the completion of the study.Meanwhile, participants in both groups should take metformin 1500mg per day throughout the whole 48 weeks. At the end of the study, data will be collected and analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
saxagliptin, glimepiride, metformin monotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
388 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saxagliptin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Glimepiride
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Saxagliptin
Other Intervention Name(s)
Onglyza，Astrazeneca
Intervention Description
5 mg/d
Intervention Type
Drug
Intervention Name(s)
Glimepiride
Other Intervention Name(s)
Amaryl，Sanofi-Aventis
Intervention Description
1mg/d, up titrated 1mg if FPG >6.1 mmol/L (110mg/dL) till 6 mg
Primary Outcome Measure Information:
Title
Proportion of subjects achieving glycemic response defined as Glycosylated hemoglobin (HbA1c) < 7.0%
Description
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%).
Time Frame
Change from Baseline after 48 weeks treatment
Secondary Outcome Measure Information:
Title
The change in blood glucose fluctuations of subjects.
Description
30 subjects of each group would be randomly chosen to evaluate blood glucose fluctuations by continuous glucose monitoring system (CGMS) before and after 48 weeks treatment.
Time Frame
Change from Baseline after 48 weeks treatment
Title
The improvement in beta-cell function of subjects
Description
All subjects would be tested in fasting proinsulin, proinsulin/insulin ratio, true insulin and C-peptide during standard meal test (75-gram instant noodles) before and after 48 weeks treatment.
Time Frame
Change from Baseline after 48 weeks treatment
Title
The change in body composition of subjects.
Description
All subjects would be measured by their weight (WT), body mass index (BMI) and waist-hip ratio (WHR) every four weeks until the end of 48 weeks treatment.
Time Frame
Change from Baseline after 48 weeks treatment
Title
Safety and tolerability of saxagliptin vs. glimepiride measured by adverse events, serious adverse events (SAEs); laboratory assessments (biochemistry, lipids, blood and urine routine tests
Description
The proportion of AEs and SAEs would be measured.Incidence of hypoglycemia episodes (defined as symptoms with glucose < 3.1 mmol/L);adverse events (AEs);serious adverse events (SAEs);laboratory assessments (biochemistry, lipids, blood and urine routine tests);other safety and tolerability parameters (ECG, vital signs, physical examination).
Time Frame
Change from Baseline after 48 weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For inclusion in the study subjects should fulfill the following criteria: 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 Exclusion Criteria: Subjects should not enter the study if any of the following exclusion criteria are fulfilled: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalong Zhu, MD, PhD
Organizational Affiliation
the Affiliated Drum Tower Hospital of Nanjing University
Official's Role
Principal Investigator
Facility Information:
Facility Name
at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30520221
Citation
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.
Results Reference
derived

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

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