Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT01154933
Eligibility Criteria:
Inclusion Criteria:
* Males or females 20-75 years of age inclusive.
* Type 2 diabetes
* On insulin therapy
* HbA1c ≥7.5% and ≤ 9%
* BMI ≥ 30 kg/m2
* Subjects on statins, ACE inhibitors, metformin, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study.
Exclusion Criteria:
* Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
* Pregnancy
* Hepatic disease (abnormal LFT's)
* Use of DPP4 inhibitors.
* Renal impairment (serum creatinine \> 1.5)
* Participation in any other concurrent clinical trial
* Any other life-threatening, non-cardiac disease
* Uncontrolled hypertension (BP \> 160/100 mm of Hg)
* Congestive Heart Failure.
* Use of an investigational agent or therapeutic regimen within 30 days of study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01154933
Study Brief:
Protocol Section:
NCT01154933