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

Type 2 Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280486
• Other study ID #: ISSSAXA0014
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: October 2017

Study information

• Verified date: March 2018
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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 ? and ?).

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Saxagliptin
5 mg/d
• Glimepiride
1mg/d, up titrated 1mg if FPG >6.1 mmol/L (110mg/dL) till 6 mg

Locations

Country	Name	City	State
China	at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (9)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Changzhou No.2 People's Hospital, Huai'an First People's Hospital, Nanjing PLA General Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University, Wuxi People's Hospital, Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Change from Baseline after 48 weeks treatment
Secondary	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.	Change from Baseline after 48 weeks treatment
Secondary	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.	Change from Baseline after 48 weeks treatment
Secondary	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).	Change from Baseline after 48 weeks treatment