Effects of sitagliptin and sulfonylurea on lipid and glucose metabolism in patients with type 2 diabetes fairly or poorly controlled with oral agents including sulfonylurea : a prospective randomized, multicenter, open-label trial

Effects of sitagliptin and sulfonylurea on lipid and glucose metabolism in patients with type 2 diabetes fairly or poorly controlled with oral agents including sulfonylurea : a prospective randomized, multicenter, open-label trial - SLIM study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006511

Enrollment

200

Registered

2011-10-11

Start date

2011-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

sitagliptin addition group sulfonylurea intensification group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)uncontrolled type 2 diabetic patients who are taking oral agents including sulfonylurea(glymepiride at a dose of 2 mg or less per day,glibenclamide at a dose of 1.25 mg or less per day,gliclazide at a dose of 40 mg or less per day)for more than 1 month. Patients whose HbA1c ranges from 6.5% to 8.5% (JDS value) 2)Patients whose Triglyceride is between 120 mg/dL and 400 mg/dL. 3)Patients who go on diets and exercise program. 4)Patients who have been received diabetes treatment for more than 6 months. 5)over 20 years age 6)Gender is not restricted. 7)Patient understands study procedures and agrees to participate in the study by giving written informed consent prior to the study start

Exclusion criteria

Exclusion criteria: 1) Patients who had diabetic ketosis, or diabetic pre-coma and coma within 6 months of the study entry. 2) Patients with severe infections, before or after operation, or with serious trauma. 3) Patients with pregnancy, possibility of pregnancy or having a breast feeding. 4) Patients with renal insufficiency (serum creatinine = and > 1.5 mg/dl) 5) Patients with serious liver damage. 6) Patients who received insulin therapy. 7) Patients who received incretin-related drugs (DPP4 inhibitor or GLP-1 receptor agonist ) 8) Patients who received rapid-acting insulin secretagogues 9) Patients who administered antihyperlipidemic agent for observation period. 10) Patients who had a history of hypersensitive reaction to DPP-4 inhibitor. 11) Patients whom the attending doctor estimated to be ineligible according to the medical rationale.

Design outcomes

Primary

Measure	Time frame
Lipid profiles(apolipoproteinB-48,six types of apolipoprotein,total cholesterol,triglyceride,HDL cholesterol,LDL cholesterol,Small dense LDL,RLP-C,LPL,campesterol,sitosterol,cholestarol,lathosterol)	—

Secondary

Measure	Time frame
HbA1c,fasting plasma glucose,1.5AG glycoalbumin,body weight change,the frequency of(hypoglycemia)adverse event	—

Countries

Japan

Contacts

Public ContactShinichi Oikawa

Fukujuji Hospital, Japan Anti-Tuberculosis Association (JATA) Division of Diabetes

shinichi@nms.ac.jp042-491-4111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026