Skip to content

Switch to oral hypoglycemic agent therapy from insulin injection in patients with type 2 diabetes

Switch to oral hypoglycemic agent therapy from insulin injection in patients with type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN35210312
Enrollment
40
Registered
2007-08-17
Start date
2005-05-01
Completion date
Unknown
Last updated
2021-11-08

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

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes

Interventions

All participants are hospitalized. On the day insulin injection therapy is completely withdrawn, the therapy with oral hypoglycemic agents (combination therapy) is initiated. The init

Sponsors

Okhotsk-kai Hospital (Japan)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes under long-term insulin injection 2. Age between 40 and 86 years 3. Insulin dosage >10 units/24 h 4. Insulin injection duration >3 months 5. C-peptide in 24-hr urine >10 micrograms 6. Fasting CPR >0.5 ng/ml

Exclusion criteria

Exclusion criteria: 1. Positive for glutamine acid decarboxylase antibody 2. ALT and/or AST >3 times the upper limit of normal 3. Presently and/or in the past suffering from heart failure 4. Ejection fraction assessed by echocardiography 50% positivity for insulin antibody 9. Diagnosis of type I diabetes 10. Pregnant or breast feeding 11. Under dialysis 12. Concomitantly using pioglitazone

Design outcomes

Primary

MeasureTime frame
Rate of success in the study. Success is defined as HbA1c at four months after the switch <7.0%.

Secondary

MeasureTime frame
Difference in mean HbA1C from the baseline compared to four-month timepoint. Differences among values of the following are also assessed (measured at months 0 and 4): 1. Serum lipid concentrations 2. Blood pressure 3. Body weight 4. Hematocrit 5. Albumin 6. Blood urea nitrogen 7. Creatinine 8. Aspartate Transaminase (AST) 9. Alanine Transaminase (ALT)

Countries

Japan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026