Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT01500850
Brief Summary:
The aim of this study is to observe changes in cardiovascular biomarkers during treatment with Lantus in patients with Type 2 Diabetes mellitus.
Detailed Description:
* Phase IV
* Indication: Diabetes mellitus Type 2
* Primary objective:
To compare fasting intact proinsulin secretion at the beginning and after a 24 week treatment period.
\- Secondary objectives: To evaluate changes in the parameters
* insulin,
* glucose,
* intact proinsulin (after a glucose challenge),
* hsCRP,
* adiponectin,
* MMP-9,
* HbA1c,
* weight
after 24 weeks of treatment.
To investigate the changes of
* glucose,
* intact proinsulin,
* hsCRP,
* adiponectin,
* HbA1c
* weight
between visit 2 (baseline), visit 6 (12 weeks) and visit 8 (final visit after 24 weeks).
To investigate the number of patients with normal values for parameters hsCRP, adiponectin, and intact proinsulin after 24 weeks of treatment (responder rates).
-Primary efficacy variable: Fasting intact proinsulin concentration at timepoint Visit 2 (Baseline) and Visit 8 (after 24 week treatment)
-Secondary efficacy variables: All secondary parameters will be assessed after 24 weeks of treatment and compared versus baseline assessment.
* Weight
* hsCRP
* Adiponectin
* MMP-9
* OGTT parameters (insulin, intact proinsulin, glucose at time point 0, 60 and 120 minutes after 24 weeks
* HOMA-IR score
* HbA1c
Additionally the following parameters will be assessed at visit 6 and will be compared with visit 2 and visit 8:
* Weight
* hsCRP
* Adiponectin
* Fasting intact Proinsulin
* Glucose
* HbA1c
* Safety Variables:
* Adverse Events
* Hypoglycaemic events
Medication/Dosage:
Insulin glargine, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)NPH Insulin, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)Insulin glulisine, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)Human Insulin, dose individually adapted to reach treatment goal (FBG ≤ 100 mg/dL)
-Study Duration: Duration of study participation for one patient is approximately 26 weeks. Overall total duration of the study is approximately 10 months.
Design:
This is a randomized in four arms, open-label, multi-center study. Population Patients with Type 2 Diabetes mellitus, Sample Size n = 60 (15 per arm)
Study:
NCT01500850
Study Brief:
Protocol Section:
NCT01500850