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Effect of pioglitazone and metformin in combination with insulin therapy in patients with type 2 diabetes

Effect of pioglitazone and metformin in combination with insulin therapy in patients with type 2 diabetes - Effect of pioglitazone and metformin in combination with insulin therapy in patients with type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003830
Enrollment
250
Registered
2010-07-01
Start date
2010-07-01
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

Insulin + Pioglitazone (pioglitazone was started with 15mg/day and titrated up to 30mg/day) Insulin + Metformin (metformin was started with 500mg/day and titrated up to 2250mg/day)

Sponsors

Chigasaki Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) A consent form for participating in this study is submitted 2) Patients with type 2 diabetes 3) Patients treated with insulin therapy 4) HbA1c >= 7.5% 5) BMI<35kg/m2

Exclusion criteria

Exclusion criteria: 1) Patients with type 1 diabetes 2) Patients receiving thiazolidiones or biguanides 3) Heart failure defined as NYHA class III or above 4) Having allergy to thiazolidiones or biguanides 5) Patients with severe liver failure or renal failure 6) History of acute coronary syndrome or cerebrovascular accident with in 3 months 7) Pregnant or breastfeeding 8) Patients with familial hypercholesterolemia 9) Other patients determined to be inappropriate by physician

Design outcomes

Primary

MeasureTime frame
Changes of HbA1c from the baseline to 24 weeks later

Secondary

MeasureTime frame
body weight change, fasting plasma glucose, postprandial plasma glucose, insulin dose requirements, lipid profile(Total cholesterol,Triglyceride,LDL-cholesterol,HDL-cholesterol), albuminuria, Cystatin C, High sensitivity CRP

Countries

Japan

Contacts

Public ContactYoshinobu Kondo

Chigasaki Municipal Hospital Department of Endocrinology and Metabolism

bleu-ciel@umin.ac.jp0467-52-1111

Outcome results

None listed

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