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Randomized controlled trial of rosiglitazone in the treatment of LADA patients

Randomized controlled trial of rosiglitazone in the treatment of LADA patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000117
Enrollment
Unknown
Registered
2008-06-23
Start date
2006-06-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

1) Latent autoimmune diabetes of adults (LADA). 2) Type 2 diabetes (T2DM).

Interventions

Group 1 LADA Placebo Group:Group 1 LADA patients treated by Placebo 8mg per day
Group 2 T2DM Placebo Group:Group 2 T2DM patients treated by Placebo 8mg per day
Group 3 LADA Rosiglitazone Group:Group 3 LADA patients treated by Rosiglitazone 8mg
Group 4 T2DM Rosiglitazone Group:Group 3 LADA patients treated by Rosiglitazone 8mg

Sponsors

Diabetes Center of CSU
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. male or female, 25~70 years old; 2.diagnosed LADA or T2DM: 1) diagnosed diabetes according to the criteria of WHO 1999; 2) no ketosis in the first 6 months after diagnosis of diabetes; 3) GADA positivity (LADA) or negativity(T2DM); 3. Obtain the informed consent.

Exclusion criteria

Exclusion criteria: 1. Gestational diabetes, secondary diabetes; 2. Liver disease or the ALT/AST was 2.5 fold higher than the the highest normal level, the TBIL was 1.5 fold higher than the highest normal level; 3. Renal disease, the serum Cr more than 1.5mg/dl or more than 115umol/L; 4. WBC<3*10^9/L and/or Plt<80*10^9/L and/or Hb<=90g/L; 5. Female who are in the pregnant period or have the plan of pregnancy in 3 years; 6. Severe systemic diseases, for Heart failure, stroke, and tumor; 7. Severe chronic diabetic complications; 8. Allergic to rosiglitazone or taken the immune inhibitory medicine; 9. Surgery or other stress, abuse of medicine.

Design outcomes

Primary

MeasureTime frame
HbA1c;B cell functio;none;Blood routine tests, liver and renel functions;

Secondary

MeasureTime frame
none;GAD;

Countries

China

Contacts

Public ContactZhiguang Zhou
zhouzg@hotmail.com+86 0 13873104348

Outcome results

None listed

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