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Comparison of glycaemic control and beta-cell function among newly diagnosed type 2 diabetic patients treated with exenatide, insulin or rosiglitazone: a multicentre randomized parallel-group trial

Comparison of glycaemic control and beta-cell function among newly diagnosed type 2 diabetic patients treated with exenatide, insulin or rosiglitazone: a multicentre randomized parallel-group trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000879
Enrollment
Unknown
Registered
2010-10-27
Start date
2010-09-01
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

Type 2 diabetes

Interventions

A:Exenatide injection (Byetta)
B:Premixed insulin analog (Humalog Mix 25)
C:Pioglitazone (Ruitong)

Sponsors

The Third Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. newly-diagnosed type 2 diabetic patients, drug naive; 2. age 30~70 years; 3. HbA1c 7.0-10.0%; 4. BMI 20~35 kg/m2, stable body weight (<=10% variation) for at least 3 months prior to screening; 5. female patients of reproductive age should practice a reliable method of birth control throughout the study.

Exclusion criteria

Exclusion criteria: 1. acute or severe chronic diabetic complications; 2. congestive heart failure (NYHA grade III-IV); 3. severe gastrointestinal disease; 4. severe osteoporosis or history of pathological fracture, or use of bisphosphonates preparation; 5. other severe intercurrent illness; 6. serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie>=133umol/L (1.5mg/dL); 7. tested positive for glutamic acid decarboxylase antibody; 8. use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug; 9. history of pancreatitis; 10. serum triglyceride >=5.0 mmol/L; 11. pregnancy.

Design outcomes

Primary

MeasureTime frame
Glycemic control, as assessed by HbA1;

Secondary

MeasureTime frame
(2)beta-cell function (first-phase insulin response;early-phase and late-phase insulin response;(1) Percentage of patients achieving HbA1c <=6.5% and effect of different interventions on fasting;

Countries

China

Contacts

Public ContactJianping Weng
wjianp@mail.sysu.edu.cn+86 020 85253239

Outcome results

None listed

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