Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-03-05 @ 9:08 AM
Study NCT ID:
NCT01500850
Status:
UNKNOWN
Last Update Posted:
2011-12-29
First Post:
2011-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use
Sponsor:
ikfe-CRO GmbH
Organization:
Study Overview
Official Title:
Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use.
Status:
UNKNOWN
Status Verified Date:
2011-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: