A randomized controlled trial of Ipragliflozin and sitagliptin

JRCT ID: jRCTs031180205

Registered date:07/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 20/11/2015
• Target sample size: 166
• Study type: Interventional
• Intervention(s): Ipragliflozin 50mg/day or sitagliptin 50mg/day

Outcome(s)

Primary Outcome

Comparison of percentage of patients who achieve the following items 52 weeks after randomization
1) Decreased HbA1c values by 0.5% or more
2) No increase of body weight

Secondary Outcome

1) Comparison of percentage of patients achieved following items after 24 weeks from randomization
1. Decrease of >= 0.5% HbA1c
2. No increase of body weight

2) Comparison of change or percent change of following items after 24 and 52 weeks from randomization
1. HbA1c, fasting plasma glucose, blood insulin/serum C-pepitide (Fasting)
2. Body weight, BMI, waist circumference
3. Serum lipid (Fasting TG, TC, LDL-C, HDL-C)
4. SBP/DBP (Casual blood pressure)
5. Urinary albumin, transferrin, NAG, electrolyte (Na, K, Cl) (Spot urine)
6. Target level achievement rate (HbA1c, blood pressure, lipid etc.)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

[Inclusion criteria before initiation of metformin monotherapy]
1) Type 2 diabetes
2) Aged from 20 to 80 years at providing consent
3) With poorly glycemic controlled, nevertheless undergo diet and exercise therapy or administrated oral hypoglycemic agents
4) HbA1c >= 6.5% and <10.0%
5) Provided written informed consent
[Inclusion criteria at randomization]
6) Patients who are only administrated identical dose of metformin (>= 500 mg/day) for 8 weeks or more
7) HbA1c >= 6.5% and <10.0%

Exclude criteria

1) Type 1 diabetes
2) With severe ketosis, diabetic coma, or precoma within 6 months from the day of providing consent
3) With severe infection, pre or post surgery, and serious trauma
4) With moderate or severe renal dysfunction (Serum Creatinine male: >= 1.3 mg/dL, female: >= 1.2 mg/dL)
5) With severe hepatic disorder
6) Has history of stroke, myocardial infarction, or other serious cardiovascular complications requiring hospitalization
7) Has history of lactic acidosis
8) Patients who drink excessive alcohol
9) Has urinary tract infection, genital infection and dehydration at providing consent
10) Administrated insulin, GLP-1 receptor agonist within 1 year
11) Is pregnant, nursing, possibly pregnant and planned to become pregnant
12) Has history of hypersensitivity to SGLT-2 inhibitors, DDP-4 inhibitors and BG
13) Considered as inadequate by the investigator

Related Information

• Primary Sponsor: Sone Hirohito
• Source(s) of Monetary Support: Astellas Pharma Inc.
• Secondary ID(s): UMIN000018364