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:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT00971659
Eligibility Criteria:
Inclusion Criteria:
* male or female subjects aged between 35 and 70 years, inclusive
* type 2 diabetes with duration \>6 months and \<10 years
* for at least 3 months: treatment solely with a long- or intermediate-acting insulin formulation (insulin glargine, insulin detemir, or NPH insulin) with or without a stable dose of metformin or treatment solely with a stable dose of metformin or combination of stable doses of metformin plus sulfonylureas
* HbA1c \>=7.0% and \<=10.0%
* if treated with antihypertensive or lipid lowering agents, the treatment regimen had to be stable during 3 months prior to study start
* written informed consent
Exclusion Criteria:
* history or presence of cancer or any clinically relevant diseases
* chronic heart failure NYHA class III or IV, unstable angina pectoris or myocardial infarction within the previous 6 months
* recurrent hypoglycemia
* abnormal lab tests at screening (ALAT and/or ASAT \>=3 times ULN), creatinine \>1.6 mg/dL in males and \>1.4 mg/dL in females
* clinically relevant ECG findings at screening
* treatment with a rapid-acting insulin or with a mixed insulin formulation during the previous 3 months
* treatment with any other OHA than metformin or metformin plus sulfonylureas during the previous 3 months
* any systemic or topical treatment with drugs known to influence glucose metabolism
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT00971659
Study Brief:
Protocol Section:
NCT00971659