Efficacy and safety of avandamet or uptitrated metformin treatment in patients with type 2 diabetes inadequately controlled with metformin alone

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13003776

Enrollment

Unknown

Registered

2013-05-10

Start date

2009-11-19

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

Avandamet:Avandamet

metformin:Avandamet

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-65 years;2. who have been diagnosed with type 2 diabetes;3. 7.5%=HbA1c=9.5%, and 7mmol/L=FPG=15 mmol/L at screening; 4. Participants had body mass index=24kg/m2;5. and were receiving 0.75g-1.0g metformin alone at constant doses for at least 6 weeks prior to entry;6. having written the consent form.

Exclusion criteria

Exclusion criteria: 1) treatment with glucose-lowing agents other than metformin within 12 weeks before screening; 2) allergic to thiazolidinedione or their ingredients; 3) treatment with exogenous insulin or receiving insulin within 12 weeks before screening; 4) history of diabetic ketoacidosis (DKA); 5) hemoglobin disease or chronic anemia with the level of hemoglobin 2.5 times the upper limit of normal, suffering from hepatic disease; 8) type 1 diabetes, gestational diabetes, or other type of diabetes(MODY, et al); 9) a history of ischemic heart disease or heart failure according to the New York Heart Association Classification Class I–IV; 10) patients taking nitrates; 11) ongoing edema requiring pharmacological treatment; 12) systemic blood pressure>170mmHg or diastolic blood pressure>100mmHg while on anti-hypertensive treatment; 13) any chronic disease requiring continuous intermittent treatment with corticosteroids; 14) breastfeeding, pregnant or planning pregnancy women (women of childbearing age before interview 1 to use effective contraception for at least 1 months); 15) patients with abnormality during screening by the investigator judgement; 16) active drug or alcohol abuse within the last 6 months or any associated condition that could preclude completion of the study; 17) patients probably accept the iodinated contrast agent during study duration; 18) ECG with QTc>500ms or unadjusted QT>600ms; or patients with bundle branch block with QTc>530ms.

Design outcomes

Primary

Measure	Time frame
HbA1;	—

Secondary

Measure	Time frame
fasting plasma glucose;post prandial glucose;fasting insulin;total cholesterol;LDL-C;HDL-C;triglyceride;CR;	—

Countries

China

Contacts

Public ContactLinong Ji

prof_jilinong@aliyun.com+86 13910978815

Outcome results

None listed

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